Northwestern University Feinberg School of Medicine

The Ken & Ruth Davee Department of Neurology

Clinical Trials

Our current active protocols are listed below. If you have any questions about the particular study protocol, please contact the study coordinator.  For more information about the research or participation in general, please call our office at 312-695-8643.

Feinberg Clinical Trials

Scientists at the medical school are conducting hundreds of clinical trials daily. Learn more about all our work via the Feinberg Office of Research Clinical Trials page. Search for trials by disease or condition.

Trials
National Parkinson Foundation Patient Registry
The purpose of this study is to collect registry data to examine the relationship between clinical symptoms and treatment in PD patients. Data collected will be used to describe differences in current treatment practices across many sites to evaluate tre…
The purpose of this study is to collect registry data to examine the relationship between clinical symptoms and treatment in PD patients. Data collected will be used to describe differences in current treatment practices across many sites to evaluate treatment and ultimately improve patient care.
• Patients diagnosed with idiopathic Parkinson’s Disease
• Must have established care with a movement disorder specialist at Northwestern
Simuni, TatyanaSimuni, Tatyana
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
STU00014255
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Friedeck, Heidi 312 503 1522
Platelet-Orientated Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
The purpose of this study is to determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, h…
The purpose of this study is to determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, heart attacks and other complications in patients who have just had a TIA or minor ischemic stroke.
Mendelson, ScottMendelson, Scott
STU00023167
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1-855-NU-STUDY
Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression
This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls…
This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.
Genetic Cohort-PD Subjects
• Have at least two of the following: resting tremor, slowness of movement, muscle rigidity
• Parkinson disease diagnosis for 7 years or less
• Male or female 18 years or older
• Confirmation of LRRK2, GBA, or SNCA genetic mutation
• Willing to undergo genetic testing

Genetic Cohort-Unaffected Subjects
• 50 years or older with LRRK2/GBA mutation or first degree relative with LRRK2/GBA mutation
• Willing to undergo genetic testing
OR
• 30 years or older with SNCA mutation or first degree relative with SNCA mutation
• Willing to undergo genetic testing
Simuni, TatyanaSimuni, Tatyana
NCT01141023 STU00031752
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Friedeck, Heidi 312 503 1519
GLORIA-AF Registry Program - Second and Third Phases
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. …
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.
Bernstein, Richard ABernstein, Richard A
NCT01468701 STU00062959
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1-855-NU-STUDY
Sleep Disturbance and Metabolic Syndrome
The goal of this study is to determine the ability of auditory stimulation with these sound waves to improve sleep, cardiovascular disease and metabolic function in patients with elevated cardiovascular disease risk factors. The study will involve a home …
The goal of this study is to determine the ability of auditory stimulation with these sound waves to improve sleep, cardiovascular disease and metabolic function in patients with elevated cardiovascular disease risk factors. The study will involve a home sleep test to look for sleep apnea and 7-days of at-home activity monitoring using a wristwatch before the inpatient visit. This study will also include surveys, blood draws, and overnight sleep studies. There is compensation for completing the study.
Need to be overweight, have high blood pressure (130/85 or higher), high blood sugar (110 or higher) in the past month, difficulty falling or staying asleep, and have daytime sleepiness and poor sleep quality. Total time commitment – 2 visits: One outpatient visit (2-3 hours) and one 5-day/4-night inpatient visit for overnight sleep studies at Northwestern Memorial Hospital.
Zee, Phyllis CZee, Phyllis C
STU00074507
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Ortiz, Rosemary J 1-888-NU-STUDY
Cardiometabolic outcomes with light exposure during sleep
The overall aim is to determine the impact of light during the sleep period on cardiometabolic outcomes and melatonin. We hypothesize that light at night contributes to circadian and sleep disruptions that may then lead to adverse cardiometabo…
The overall aim is to determine the impact of light during the sleep period on cardiometabolic outcomes and melatonin. We hypothesize that light at night contributes to circadian and sleep disruptions that may then lead to adverse cardiometabolic outcomes. Light pollution, and specifically light at night, has been shown to impact circadian rhythms via changes to melatonin, sleep, and other parameters. Poor sleep, changes in melatonin, and circadian disturbances are known to affect cardiometabolic outcomes. Therefore, it is plausible that light exposure during the sleep period may adversely impact next day cardiometabolic outcomes. Understanding the consequences of light during the sleep period is of great interest considering the high prevalence of light pollution in modern society.
If you are 18-40 years of age with a regular sleeping schedule. Please visit https://www.surveymonkey.com/s/LANstudy
Zee, Phyllis CZee, Phyllis C
STU00094737
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Cheung, Ivy N 1-888-NU-STUDY
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Carotid revascularization for primary prevention of stroke (CREST-2) is a multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in…
Carotid revascularization for primary prevention of stroke (CREST-2) is a multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.
Eskandari, MarkEskandari, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02089217 STU00200290
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Vyas, Riddhi 312 926 4801
Biochronicity Grand Challenge: Human Time Stamp Development, Validation and Prediction
This research is being done to develop a diagnostic test that will determine the time of your internal clock from a single blood draw. We want to determine whether changes to the internal clock, reflected in this …
This research is being done to develop a diagnostic test that will determine the time of your internal clock from a single blood draw. We want to determine whether changes to the internal clock, reflected in this blood test, can predict recovery from traumatic brain injury.
Between the ages of 18-55 and have had a traumatic brain injury.
Zee, Phyllis CZee, Phyllis C
STU00200445
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Gendy, Maged 1-888-NU-STUDY
SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
The purpose of this study placebo-controlled, randomized, double-blind study is to assess the safety and efficacy of SYN120 in …
The purpose of this study placebo-controlled, randomized, double-blind study is to assess the safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already treated with a stable dose of a cholinesterase inhibitor.
Simuni, TatyanaSimuni, Tatyana
NCT02258152 STU00200019
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1-888-NU-STUDY
Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate (110 mg or 150 mg, oral b.i.d.) versus acetylsalicylic acid (100 mg oral q.d.) in patients with Embolic Stroke of Undetermined Source (RESPECT ESUS)
Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate (110 mg or 150 mg, oral b.i.d.) versus acetylsalicylic acid (100 mg oral q.d.) in patients with Embolic Stroke of Undetermined Source (RESPECT ESUS)
Caprio, FanCaprio, Fan
STU00200255
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1-855-NU-STUDY
Circadian rhythms and epilepsy: a prospective study
This study is to further understand the link between epilepsy, sleep and circadian rhythms. We propose to characterize sleep-wake and circadian rhythm patterns in patients with epilepsy (PWE). To assess the interactions between circadian function an…
This study is to further understand the link between epilepsy, sleep and circadian rhythms. We propose to characterize sleep-wake and circadian rhythm patterns in patients with epilepsy (PWE). To assess the interactions between circadian function and sleep quality with seizure frequency and timing by data from self- reported sleep and circadian chronotype questionnaires, sleep diaries, seizure type and frequency as reported by the subjects’ primary physician, and objective sleep (actigraphy) and circadian rhythm measures.
Adults (18 years of age and older) with generalized seizures and focal seizures.
Patients are allowed to remain on their usual regimen of antiepileptic medications.

Zee, Phyllis CZee, Phyllis C
STU00201284
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Erlikh, Natanie 1-888-NU-STUDY
A Phase 3 Study to Examine the Efficacy, Safety and Tolerability of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease
A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patie…
A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to determine the efficacy, safety and tolerability of APL-130277.
Zadikoff, CindyZadikoff, Cindy
NCT02469090 STU00201467
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1-855-NU-STUDY
Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients Using Levodopa
Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part …
Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).
Zadikoff, CindyZadikoff, Cindy
NCT02453386 STU00201468
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1-855-NU-STUDY
Modeling Neuroscience for Enhancing Memory Operations through Non-Invasive Channels (MNEMONIC)
Slow wave sleep, or deep sleep, is important for memory consolidation. Enhancing slow wave or deep sleep may be beneficial for memory performance. We have recently developed a new approach to increase slow …
Slow wave sleep, or deep sleep, is important for memory consolidation. Enhancing slow wave or deep sleep may be beneficial for memory performance. We have recently developed a new approach to increase slow wave sleep by delivering sound waves played through headphones in a specific sequence. When applied during sleep the sound waves increase the total amount and amplitude of deep slow wave sleep. The goal of this study is to determine the ability of these sound waves to improve sleep and memory. We are looking for people who healthy. This study would involve a total of 5 visits (2 inpatient visits and 3 outpatient visits). The first visit is a detailed screening visit which involves informed consent, medical history, physical examination, and surveys. That visit takes place at the Circadian Rhythms and Sleep Research Laboratory in Abbott Hall, located in the Northwestern University Chicago Campus. You will also be given an activity monitor that senses movement and is worn like a watch for 1 week and a home sleep test to look for sleep apnea to wear for 1 night. You will be asked to return the devices either in person or a pre-paid envelope. The second and fourth visit is a 3-day/2-night stay at Northwestern Memorial Hospital and involves sleep studies each night. You will also be given some surveys and brief attention testing. There will be blood draws 2 times each day stay starting after the first night and a few blood draws overnight. You will be randomized (like a coin flip) to one of two groups: the sound wave stimulation or a sham-stimulation (like a placebo). You will not be allowed to know which group you are in. On the 2nd night of each visit, this stimulation or sham stimulation will be applied. Following each inpatient visit your will return 48 hours later to complete 1 hour of memory tasks. For your participation, you will get up to $900 in compensation. If you have questions about the study, you may ask now. You will also get more details and have more time to ask questions at the first study visit if you are interested and are eligible for this study.
18-35 years old
Zee, Phyllis CZee, Phyllis C
STU00202059
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Gendy, Maged 312 503 2519
Attention Bias: Testing a Potential Marker for the Diagnosis of Atypical Movement Disorders
The purpose of this study is to determine whether problems with attention lead to abnormal movements. The study involves a few thinking tests to determine if certain patterns of thinking or focusing can be ass…
The purpose of this study is to determine whether problems with attention lead to abnormal movements. The study involves a few thinking tests to determine if certain patterns of thinking or focusing can be associated with abnormal movements.
• Adult patients with a clinically established or documented psychogenic movement disorder
• Adult patients with a diagnosis of benign familial/ essential tremor as made by a movement disorder specialist
• Healthy adults who do not have any suspected or known neurologic movement disorders

Bega, DannyBega, Danny
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
STU00202673
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Woods, Zakary 1-888-NU-STUDY
Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease
The objective of this study is to determine the mechanisms of stroke in patients with Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of antegrade flow through the sten…
The objective of this study is to determine the mechanisms of stroke in patients with Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of antegrade flow through the stenotic artery, distal tissue perfusion to the affected territory, and artery-to-artery embolism. The hypothesis is that non-invasive imaging biomarkers that stratify stroke risk and distinguish mechanisms of IAD. This prospective multicenter study will enroll 175 patients with recently symptomatic high-grade IAD. Patients will be studied within 21 days of the index event (allowing appropriate time to arrange for diverse imaging modalities), with the following advanced neuroimaging techniques to elucidate mechanisms of recurrent ischemia: - Quantitative magnetic resonance imaging (QMRA) to assess volumetric flow rate through the stenotic artery. - Magnetic resonance perfusion weighted imaging (PWI-MRI) to determine distal tissue perfusion. - Vasomotor reactivity by Transcranial Doppler using the breath-holding technique (BHI-TCD) to assess compensatory flow characteristics to the territory distal to the affected artery; - Transcranial Doppler with embolic signal monitoring to evaluate artery-to-artery embolism that reflects plaque instability. Patients will receive standardized medical management and its effectiveness on blood pressure, lipid, and glycemic control will be monitored. The primary outcome is recurrent stroke in the territory of the stenotic artery during a 1-year follow-up period; secondary outcomes are: a) new asymptomatic ischemic lesions on MRI in the distribution of the stenotic artery at 6-8 weeks, and b) transient ischemic attack (TIA) in the distribution of the stenotic artery during a 1-year follow-up period. Patients will be recruited at various sites that will be trained and certified on the imaging techniques employed. Raw imaging data will be interpreted centrally.
Inclusion
1- Symptomatic stroke/TIA due to IAD

2- Stenosis 70-99% measured on CTA/DSA/MRA as SOC (WASID criteria) and MRA flow gap (send to bay state)


3-Stroke/TIA diagnosed on CT or MRI

3- TIA with DWI abnormalities or ≥2 stereotyped events (weakness, aphasia)

5- IAD-Intracranial Carotid
MCA, Intracranial Vertebral,
Basilar

6- Age >30;
7- 30-49 also IAD in another vascular bed (coronary, extracranial carotid, peripheral) or the presence of 2 or more risk factors (hypertension, diabetes mellitus, hyperlipidemia, tobacco abuse within the last 2 years).

8- Enrollment within 21 days of index event

.
Exclusion
1- No ACA No PCA
2- Other cause of stroke/TIA besides ICAD
3- Angioplasty/stenting performed or planned on target vessel or on a vessel proximal to it.
4- Contraindications to MRI,
5- Pregnancy, lactation, morbid obesity, and severe claustrophobia.
6- Cr >1.5 mg/dL or GFR <30 ml/min/1.73 m2;
7- Known allergy to gadolinium.

Ansari, Sameer AhmadAnsari, Sameer Ahmad
NCT02121028 STU00202274
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Muzaffar, Ayesha 312 926 4251
RESTORE: A clinical study of patients with symptomatic neuRogenic orthostatic hypotEnsion to assess Sustained effecTs Of dRoxidopa thErapy
The purpose of this study is to evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonom…
The purpose of this study is to evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH) (dizziness, light-headedness, or feelings that they are about to black out).
• 18 years or older and able to stand (with or without limited assistance)
• Clinical diagnosis of symptomatic orthostatic hypotension
Zadikoff, CindyZadikoff, Cindy
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
NCT02586623 STU00202923
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Rutkowski, Anna 1-888-NU-STUDY
Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia
The MATRICS Study - This study aims to investigate the effectiveness of different combinations and sequences of evidence-based treatment strategies for people with both Obstructive Sleep Apnea and Insomnia. Participants will be rand…
The MATRICS Study - This study aims to investigate the effectiveness of different combinations and sequences of evidence-based treatment strategies for people with both Obstructive Sleep Apnea and Insomnia. Participants will be randomly assigned to one of three treatment conditions using a medical device known as CPAP, or using this device in combination with a behavioral treatment to improve sleep.
Inclusion Criteria:
Males and Females age 18 and older;
Meets criteria for Obstructive Sleep Apnea;
Meets criteria for an Insomnia Disorder; Able to make around 15 in-person visits over 7-9 months.
Exclusion Criteria:
Comorbid medical condition that requires immediate treatment of OSA;
Severe cases of OSA that require immediate treatment;
Psychiatric conditions that may interfere with study protocol or uncontrolled psychiatric conditions that require immediate treatment;
Comorbid sleep disorders that require treatment outside of the study protocol;
Other sleep-related breathing disorder besides OSA;
Excessive daytime sleepiness that requires immediate treatment or presents significant risk;
CPAP use or formal CBT for insomnia within the past 6 months.
Ong, Jason COng, Jason C
NCT01785303 STU00203478
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Yap, Bonnie 312 503 6627
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in subjects 55 Years and Older with Insomnia Disorder
This study is being done by Eisai Inc., a company that does drug research studies in order to develop ne…
This study is being done by Eisai Inc., a company that does drug research studies in order to develop new drugs. Eisai is studying a drug called lemborexant or E2006, being developed to treat people with insomnia disorder. The main goal of this study is to compare the effectiveness of two strengths of lemborexant with another drug called zolpidem tartrate extended release tablets (zolpidem ER), (also known as Ambien® Controlled Release tablets) and placebo. Everyone in the study will get placebo at some time during the study. The placebo is a tablet that looks like lemborexant or zolpidem ER but has no active drug in it. The study will last about 10 weeks and involves 9 visits of which 7 of those visits will be overnight sleep studies follow with daytime testing.
Female age 55 years old or male age 65 or older. Trouble falling asleep and/or staying asleep.
Abbott, SabraAbbott, Sabra
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
NCT02783729 STU00203381
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Ortiz, Rosemary J 312 908 1024
Enroll-HD: A Prospective Registry Study in a Global Huntington’s Disease Cohort
The purpose of this research study is to collect clinical information about patients and their health. We will also collect biological samples, such as blood and DNA (the genetic material in your blood). Researchers wil…
The purpose of this research study is to collect clinical information about patients and their health. We will also collect biological samples, such as blood and DNA (the genetic material in your blood). Researchers will use this information and samples to learn more about HD and to try to find new treatments for the disease. People from many countries contribute to Enroll-HD.
Individuals 18 yrs or older affected by Huntington's Disease (HD) or from a HD family or are a "community control" (a person who does not carry the HD genetic mutation that causes Huntington's disease and is not part of an HD family, but would like to participate in the study). Research visits are conducted yearly and will consists of a collection of medical and family history and biological samples.
Bega, DannyBega, Danny
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
STU00203021
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Brown, ZsaZsa 312 503 4121
A Phase IIb/III, Randomized, Double-Blind, Placebo-Controlled Trial of BHV-4157 in Adult Subjects with Spinocerebellar Ataxia
The purpose of this study is to evaluate the possible risks and effectiveness of the study drug BHV-4157 on ataxia symptoms in participants with spinocerebellar ataxia (SCA). …
The purpose of this study is to evaluate the possible risks and effectiveness of the study drug BHV-4157 on ataxia symptoms in participants with spinocerebellar ataxia (SCA). The effects of the study drug will be compared to placebo, an inactive substance made to look like an active medicine. Participants will either get the study drug or placebo.
• Age 18-75
• Ability to provide written informed consent
• Subjects with a known or suspected diagnosis of the following specific
hereditary ataxias: SCA1, SCA2, SCA6, SCA8 and SCA10;
1. Participants should have confirmed genotypic diagnosis from a CLIA-certified lab or a family member has had such testing
2. Participants must be willing to undergo genetic testing from a CLIA-certified lab if testing has not yet been previously done on the participant and a copy of results is not available for verification
• Ability to walk 8 meters without assistance (canes and other devices allowed)
• Minimum of 6 years of education and fluent in English
• Subjects must have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol
• Subjects must be able to understand and agree to comply with the prescribed dosage regimens and procedures; report for regularly scheduled office visits; and reliably communicate with study personnel about adverse events and concomitant medications
Opal, PuneetOpal, Puneet
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
NCT02960893 STU00204304
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Tripathi, Priya Rakesh 1-888-NU-STUDY
The Role of Circadian Dysfunction in Hepatic Encephalopathy in Patients with Cirrhosis
Individuals with advanced liver disease (cirrhosis) often report new or worsening sleep problems. Additionally, cirrhosis increases
1) Diagnosis of end-stage liver disease or cirrhosis; 2) being evaluated for liver transplant; 3) Age >=18yo; 4) fluent in English; 5) no severe kidney disease (for example, patients currently on dialysis are not eligible)
Kim, MinjeeKim, Minjee
  • Map it 201 E. Huron St.
    Chicago, IL
STU00204423
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Kim, Minjee 312 695 7976
Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA) to Study Natural History and Genetic Modifiers in Spinocerebellar Ataxia (SCA)
The purpose of this study is to collect natural history data among ataxia patients in a cohort of SCA 1, 2, 3, 6 patients using clinic-based neurolo…
The purpose of this study is to collect natural history data among ataxia patients in a cohort of SCA 1, 2, 3, 6 patients using clinic-based neurological rating scales and performance measures. Another study goal is to identify new measures of ataxia, cognition, and neurobehavior in comparison to traditional clinician rating methods. The gene analysis is expected to establish a relationship, if any, between age at onset of disease and disease progression rates.
• Age 18 and older
• Presence of symptoms and signs of ataxia
• Molecular diagnosis of SCA 1, 2, 3, 6 either in the participant or an affected family member
• Willingness to participate in the study and ability to give informed consent.
Opal, PuneetOpal, Puneet
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
NCT01060371 STU00204294
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Brown, ZsaZsa 312 503 4121