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Trial record 76 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine

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ClinicalTrials.gov Identifier: NCT00720759
Recruitment Status : Completed
First Posted : July 23, 2008
Results First Posted : March 7, 2014
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Stroke
Interventions Drug: D-cycloserine + distributed treatment
Behavioral: D-cycloserine + condensed treatment
Drug: Placebo + distributed treatment
Behavioral: Placebo + condensed treatment
Enrollment 24
Recruitment Details Subjects were recruited between 1/5/10 and 6/3/11. Recruitment sites included: 1) The VA Rehabilitation Research and Development Brain Rehabilitation Research Center of Excellence at the Malcom Randall VA Medical Center, Gainesville, Florida; and outpatient clinics of the Brooks Rehabilitation Hospital, Jacksonville, Florida.
Pre-assignment Details All potential participants who met inclusion and exclusion criteria for the study and who provided informed consent were promptly randomized and entered into the study.
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
Hide Arm/Group Description

D-cycloserine + distributed treatment

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

D-cycloserine + condensed treatment

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 + distributed treatment

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

Placebo + condensed treatment

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

Period Title: Overall Study
Started 6 6 6 6
Completed 6 5 5 6
Not Completed 0 1 1 0
Reason Not Completed
Lost to Follow-up             0             1             1             0
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4 Total
Hide Arm/Group Description

D-cycloserine + distributed treatment

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

D-cycloserine + condensed treatment

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 + distributed treatment

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

Placebo + condensed treatment

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

Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  66.7%
6
 100.0%
4
  66.7%
4
  66.7%
18
  75.0%
>=65 years
2
  33.3%
0
   0.0%
2
  33.3%
2
  33.3%
6
  25.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 24 participants
60.33  (6.71) 57.83  (4.40) 56.50  (12.31) 58.17  (11.63) 58.2  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 24 participants
Female
3
  50.0%
4
  66.7%
3
  50.0%
2
  33.3%
12
  50.0%
Male
3
  50.0%
2
  33.3%
3
  50.0%
4
  66.7%
12
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 6 participants 6 participants 24 participants
6 6 6 6 24
1.Primary Outcome
Title Wolf Motor Function Test (Time)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
Hide Arm/Group Description:

D-cycloserine + distributed treatment

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

D-cycloserine + condensed treatment

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 + distributed treatment

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

Placebo + condensed treatment

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

Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.21  (14.26) 29.69  (39.06) 19.09  (32.55) 26.05  (31.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1, Arm 2, Arm 3, Arm 4
Comments A general linear model was employed. The independent variables were baseline WMFT score, treatment (condensed vs distributed), treatment (d-cycloserine vs placebo), and treatment interaction effect. The dependent measure was WMFT score at 3 months post treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value .83
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.54
Estimation Comments [Not Specified]
Time Frame Adverse event data were collected from trial entry through 3 months following treatment completion.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
Hide Arm/Group Description

D-cycloserine + distributed treatment

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

D-cycloserine + condensed treatment

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 + distributed treatment

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

Placebo + condensed treatment

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

All-Cause Mortality
Arm 1 Arm 2 Arm 3 Arm 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2 Arm 3 Arm 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      1/6 (16.67%)      0/6 (0.00%)    
Nervous system disorders         
Recurrent stroke  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Standard to our IRB
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Arm 2 Arm 3 Arm 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      1/6 (16.67%)      1/6 (16.67%)    
Nervous system disorders         
insomnia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders         
skin tear  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, Standard to our IRB
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Stephen E. Nadeau
Organization: VAHSRD
Phone: 352-374-6082
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00720759     History of Changes
Other Study ID Numbers: B6346-R
First Submitted: July 21, 2008
First Posted: July 23, 2008
Results First Submitted: October 7, 2013
Results First Posted: March 7, 2014
Last Update Posted: March 7, 2014