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Neurobiological Principles Applied to the Rehabilitation of Stroke Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00715520
First Posted: July 15, 2008
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Cathrin Buetefisch, Emory University
Results First Submitted: October 12, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Stroke
Interventions: Other: Transcranial Magnetic Stimulation (TMS)
Drug: Carbidopa-Levodopa
Drug: Methylphenidate
Drug: Amphetamine Sulfate
Drug: Placebo
Other: Sham Transcranial Magnetic Stimulation (TMS)
Other: Transcranial Magnetic Stimulation (TMS) Training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited between April 2007 and August 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aim 1 Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
Aim 2 Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
Aim 3 Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.

Participant Flow:   Overall Study
    Aim 1   Aim 2   Aim 3
STARTED   20   10   3 
COMPLETED   10   9   1 
NOT COMPLETED   10   1   2 
Screen failure                8                1                1 
Withdrawal by Subject                2                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants included in the baseline analysis received a study intervention and completed all study procedures.

Reporting Groups
  Description
Aim 1 Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
Aim 2 Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
Aim 3 Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
Total Total of all reporting groups

Baseline Measures
   Aim 1   Aim 2   Aim 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   9   1   20 
Age 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 10   9   1   20 
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7  70.0%      7  77.8%      1 100.0%      15  75.0% 
>=65 years      3  30.0%      2  22.2%      0   0.0%      5  25.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 10   9   1   20 
Female      5  50.0%      6  66.7%      1 100.0%      12  60.0% 
Male      5  50.0%      3  33.3%      0   0.0%      8  40.0% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 0   0   0   0 
            0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States         
Participants Analyzed 
[Units: Participants]
 10   9   1   20 
United States   10   9   1   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)   [ Time Frame: Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) ]

2.  Primary:   Aim 1: Mean Peak Acceleration of Wrist Extension Movements   [ Time Frame: Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) ]

3.  Secondary:   Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse   [ Time Frame: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) ]

4.  Secondary:   Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse   [ Time Frame: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) ]

5.  Secondary:   Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency   [ Time Frame: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) ]

6.  Secondary:   Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency   [ Time Frame: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) ]

7.  Secondary:   Aim 3: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)   [ Time Frame: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) ]

8.  Secondary:   Aim 3: Mean Peak Acceleration of Wrist Extension Movements   [ Time Frame: Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Target enrollment for aim 3 was not me due to difficulty identifying participants that met the inclusion criteria. Therefore the study team did not have a sufficient sample size to complete any data analysis for this aim.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Cathrin Buetefisch
Organization: Emory University
phone: 4047121894
e-mail: cathrin.buetefisch@emory.edu



Responsible Party: Cathrin Buetefisch, Emory University
ClinicalTrials.gov Identifier: NCT00715520     History of Changes
Other Study ID Numbers: IRB00046953
R01NS060830-01A1 ( U.S. NIH Grant/Contract )
NPARR01 ( Other Identifier: Other )
First Submitted: July 11, 2008
First Posted: July 15, 2008
Results First Submitted: October 12, 2017
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017