StrokePhase 2NCT00720759
Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine
A Phase 2 study testing D-cycloserine + distributed treatment and D-cycloserine + condensed treatment in people with Stroke, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- D-cycloserine + distributed treatment and D-cycloserine + condensed treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Nov 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of more than minor head trauma,
- subarachnoid hemorrhage,
- dementia or other neurodegenerative disease,
- multiple sclerosis,
- lobar intracerebral hemorrhage,
- epilepsy,
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
About this study
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.
Read the 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:
- 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.
- Conditions
- Stroke
- Being tested
- D-cycloserine + distributed treatment, D-cycloserine + condensed treatment, Placebo + distributed treatment, Placebo + condensed treatment
- Keywords
- stroke, hemiparesis, randomized controlled trial, d-cycloserine, distributed practice, constraint induced movement therapy
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserine + distributed treatmentDrug
Also called spaced training
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
D-cycloserine + condensed treatmentBehavioural
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 + distributed treatmentDrug
Also called spaced training
Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session
Placebo + condensed treatmentBehavioural
Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | D-cycloserine + distributed treatment Receives: Drug: D-cycloserine + distributed treatment |
| Arm 2 | Sham comparator | D-cycloserine + condensed treatment Receives: Behavioral: D-cycloserine + condensed treatment |
| Arm 3 | Placebo comparator | Placebo + distributed treatment Receives: Drug: Placebo + distributed treatment |
| Arm 4 | Placebo comparator | Placebo + condensed treatment Receives: Behavioral: Placebo + condensed treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startJul 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stephen E Nadeau, MD BS BS, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720759
- Sponsor's protocol ID
- B6346-R
- Status last verified
- Jan 2014
- First submitted
- 21 Jul 2008
- Last updated
- 7 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine
- ClinicalTrials.gov ID
- NCT00720759
- Acronym / sponsor ID
- B6346-R
- Conditions
- Stroke
- Keywords
- stroke, hemiparesis, randomized controlled trial, d-cycloserine, distributed practice, constraint induced movement therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Jul 2008 (estimated)
- Results
- Posted 7 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: D-cycloserine + distributed treatmentD-cycloserine + distributed treatment |
| Arm 2 | Sham comparator | Behavioral: D-cycloserine + condensed treatmentD-cycloserine + condensed treatment |
| Arm 3 | Placebo comparator | Drug: Placebo + distributed treatmentPlacebo + distributed treatment |
| Arm 4 | Placebo comparator | Behavioral: Placebo + condensed treatmentPlacebo + condensed treatment |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- History of more than minor head trauma,
- subarachnoid hemorrhage,
- dementia or other neurodegenerative disease,
- multiple sclerosis,
- lobar intracerebral hemorrhage,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-cycloserine + distributed treatmentAlso: spaced trainingSubjects 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 | Drug | Arm 1 |
| D-cycloserine + condensed treatmentSubjects 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 | Behavioural | Arm 2 |
| Placebo + distributed treatmentAlso: spaced trainingSubjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session | Drug | Arm 3 |
| Placebo + condensed treatmentSubjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session | Behavioural | Arm 4 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen E Nadeau, MD BS BS principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-cycloserine + distributed treatment and D-cycloserine + condensed treatment in people with Stroke, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (Time) (time frame: 3 months after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2014.