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Driving Neuroplasticity With Nerve Stimulation and Modified CIT

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02587234
First Posted: October 27, 2015
Last Update Posted: July 14, 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.
Information provided by (Responsible Party):
Lumy Sawaki, University of Kentucky
Results First Submitted: June 16, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Stroke
Cerebrovascular Accident
Intervention: Device: peripheral nerve stimulation

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Active

2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training

peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves

Sham PNS

2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training

peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves


Participant Flow:   Overall Study
    Active   Sham PNS
STARTED   11   10 
COMPLETED   10   7 
NOT COMPLETED   1   3 
Withdrawal by Subject                1                1 
Lost to Follow-up                0                2 



  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.
No text entered.

Reporting Groups
  Description
Active PNS

2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training

peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves

Sham PNS

2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training

peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves

Total Total of all reporting groups

Baseline Measures
   Active PNS   Sham PNS   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   10   21 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 10   9   19 
   56.7  (8.6)   54.6  (10.2)   55.7  (9.2) 
[1] Age calculations exclude the subject from the Active PNS group who withdrew during the interventions and the subject from the Sham PNS group who withdrew during the interventions.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 10   9   19 
Female      7  70.0%      3  33.3%      10  52.6% 
Male      3  30.0%      6  66.7%      9  47.4% 
[1] Numbers do not include the 2 subjects who withdrew prior to completing the interventions.


  Outcome Measures
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1.  Primary:   Change in Wolf Motor Function Test (WMFT), Timed Portion   [ Time Frame: baseline, post-intervention, 1-month follow-up ]

2.  Secondary:   Change in Fugl Meyer Assessment Motor Score   [ Time Frame: baseline, post-intervention, 1-month follow-up ]

3.  Secondary:   Change in Action Research Arm Test (ARAT)   [ Time Frame: baseline, post-intervention, 1-month follow-up ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lumy Sawaki, MD, PhD
Organization: University of Kentucky
e-mail: lumy.sawaki@uky.edu



Responsible Party: Lumy Sawaki, University of Kentucky
ClinicalTrials.gov Identifier: NCT02587234     History of Changes
Other Study ID Numbers: R03HD049408 ( U.S. NIH Grant/Contract )
First Submitted: October 23, 2015
First Posted: October 27, 2015
Results First Submitted: June 16, 2017
Results First Posted: July 14, 2017
Last Update Posted: July 14, 2017