Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine

NCT00720759 | Completed Phase 2 Results

• 1 other identifier: B6346-R
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; hemiparesis; randomized controlled trial; d-cycloserine; distributed practice; constraint induced movement therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after completion of treatment

Study Arms (4)

Arm 1

EXPERIMENTAL

D-cycloserine + distributed treatment

Drug: D-cycloserine + distributed treatment

Arm 2

SHAM COMPARATOR

D-cycloserine + condensed treatment

Behavioral: D-cycloserine + condensed treatment

Arm 3

PLACEBO COMPARATOR

Placebo + distributed treatment

Drug: Placebo + distributed treatment

Arm 4

PLACEBO COMPARATOR

Placebo + condensed treatment

Behavioral: Placebo + condensed treatment

Interventions

D-cycloserine + distributed treatment DRUG

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

Also known as: spaced training

Arm 1

D-cycloserine + condensed treatment BEHAVIORAL

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

Arm 2

Placebo + distributed treatment DRUG

Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session

Also known as: spaced training

Arm 3

Placebo + condensed treatment BEHAVIORAL

Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session

Arm 4

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Stephen E. Nadeau
• Organization: VAHSRD

stephen.nadeau@va.gov

352-374-6082

Study Officials

• Stephen E Nadeau, MD BS BS

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 23, 2008
• Study Start: July 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 7, 2014
• Results First Posted: March 7, 2014

Record last verified: 2014-01

Locations

US (1)