Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine
Primary Purpose
Stroke
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
D-cycloserine + distributed treatment
D-cycloserine + condensed treatment
Placebo + distributed treatment
Placebo + condensed treatment
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, hemiparesis, randomized controlled trial, d-cycloserine, distributed practice, constraint induced movement therapy
Eligibility Criteria
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.
Sites / Locations
- North Florida/South Georgia Veterans Health System, Gainesville, FL
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Sham Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
D-cycloserine + distributed treatment
D-cycloserine + condensed treatment
Placebo + distributed treatment
Placebo + condensed treatment
Outcomes
Primary Outcome Measures
Wolf Motor Function Test (Time)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00720759
First Posted
July 21, 2008
Last Updated
January 21, 2014
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00720759
Brief Title
Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine
Official Title
Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Each year 730,000 Americans experience a stroke. Forty percent are left with significant paralysis of one arm. Certain types of physical therapy, for example constraint induced movement therapy (CIMT), have been shown to be effective in improving arm function. However, for most subjects, improvement is modest. In this trial, we test two approaches that may increase the amount of improvement achieved: 1) distributing treatment over a greater amount of time; and 2) adding a drug, d-cycloserine, which theoretically enhances the molecular mechanisms of learning.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, hemiparesis, randomized controlled trial, d-cycloserine, distributed practice, constraint induced movement therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
D-cycloserine + distributed treatment
Arm Title
Arm 2
Arm Type
Sham Comparator
Arm Description
D-cycloserine + condensed treatment
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
Placebo + distributed treatment
Arm Title
Arm 4
Arm Type
Placebo Comparator
Arm Description
Placebo + condensed treatment
Intervention Type
Drug
Intervention Name(s)
D-cycloserine + distributed treatment
Other Intervention Name(s)
spaced training
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
D-cycloserine + condensed treatment
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo + distributed treatment
Other Intervention Name(s)
spaced training
Intervention Description
Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session
Intervention Type
Behavioral
Intervention Name(s)
Placebo + condensed treatment
Intervention Description
Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session
Primary Outcome Measure Information:
Title
Wolf Motor Function Test (Time)
Description
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.
Time Frame
3 months after completion of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen E Nadeau, MD BS BS
Organizational Affiliation
North Florida/South Georgia Veterans Health System, Gainesville, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
12. IPD Sharing Statement
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Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine
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