- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00720759
Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine
Study Overview
Status
Conditions
Detailed Description
Each year, 730,000 Americans experience a stroke. Forty percent are left with persistent impairment of upper extremity function. Although scientifically vetted rehabilitation therapies for this impairment are starting to emerge, current treatment is generally unsatisfactory. Therapies that seek to engage neuroplastic mechanisms constitute one approach to this problem. A good example is constraint induced movement therapy (CIMT), a treatment that seeks, through extensive functional task practice, to overcome an acquired intentional predisposition to use the spared arm (learned non-use), and to improve motor function in the affected arm. CIMT has been tested in a host of trials, most recently a multicenter randomized controlled trial (RCT) - the EXCITE trial. These trials have generally demonstrated that on average, the treatment shows efficacy, and the results from the RCT indicate that it is more efficacious than "standard" therapies. However, problems with CIMT can be readily identified that pose research challenges: 1) on average, efficacy is limited; 2) only a fraction of subjects show substantial benefit. We propose to address these two problems in a pilot RCT of 20 subjects that will test two modifications of standard CIMT: 1) addition of a drug, d-cycloserine, that may enhance neuroplasticity by potentiating NMDA-glutamate receptor-mediated learning mechanisms; 2) delivery of a fixed amount of CIMT over a greater number of days, which according to learning research, may enhance long-term retention of gains.
All subjects in this trial will receive CIMT. Subjects will be randomized to one of 4 groups:
A. CIMT + d-cycloserine, more condensed treatment B. CIMT + d-cycloserine, less condensed treatment C. CIMT + placebo, more condensed treatment D. CIMT + placebo, less condensed treatment The primary outcome measure will be performance on the Wolf Motor Function Test (time) 3 months after completion of treatment.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Florida
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Gainesville, Florida, United States, 32608
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 21-80,
- of either sex,
- diverse ethnic background,
- s/p a single unilateral hemispheric stroke 6 or more months prior,
- who meet upper extremity functional criteria for participation in constraint induced movement therapy.
Exclusion Criteria:
- History of more than minor head trauma,
- subarachnoid hemorrhage,
- dementia or other neurodegenerative disease,
- multiple sclerosis,
- lobar intracerebral hemorrhage,
- epilepsy,
- drug or alcohol abuse,
- serious medical illness,
- serum creatinine >1.5,
- schizophrenia,
- major refractory depression,
- insufficient cardiopulmonary function to participate in low-intensity,
- sustained upper extremity exercise,
- severe visual impairment,
- pregnancy,
- inability to understand the potential risks and benefits of the study,
- personally provide informed consent, and
- understand and cooperate with treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
D-cycloserine + distributed treatment
|
Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
Other Names:
|
Sham Comparator: Arm 2
D-cycloserine + condensed treatment
|
Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
|
Placebo Comparator: Arm 3
Placebo + distributed treatment
|
Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session
Other Names:
|
Placebo Comparator: Arm 4
Placebo + condensed treatment
|
Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wolf Motor Function Test (Time)
Time Frame: 3 months after completion of treatment
|
The Wolf Motor Function Test (time) score is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers.
Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task.
Score range on the WMFT-T is 0-120, lower scores being better.
|
3 months after completion of treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stephen E Nadeau, MD BS BS, North Florida/South Georgia Veterans Health System, Gainesville, FL
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Stroke
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antimetabolites
- Anti-Bacterial Agents
- Antitubercular Agents
- Antibiotics, Antitubercular
- Anti-Infective Agents, Urinary
- Renal Agents
- Cycloserine
Other Study ID Numbers
- B6346-R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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