ClinicalTrials.gov
ClinicalTrials.gov Menu

Driving Neuroplasticity With Nerve Stimulation and Modified CIT

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.
ClinicalTrials.gov Identifier: NCT02587234
Recruitment Status : Completed
First Posted : October 27, 2015
Results First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Lumy Sawaki, University of Kentucky

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
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Sham PNS
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 11 10
Completed 10 7
Not Completed 1 3
Reason Not Completed
Withdrawal by Subject             1             1
Lost to Follow-up             0             2
Arm/Group Title Active PNS Sham PNS Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 19 participants
56.7  (8.6) 54.6  (10.2) 55.7  (9.2)
[1]
Measure Analysis Population Description: 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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Female
7
  70.0%
3
  33.3%
10
  52.6%
Male
3
  30.0%
6
  66.7%
9
  47.4%
[1]
Measure Analysis Population Description: Numbers do not include the 2 subjects who withdrew prior to completing the interventions.
1.Primary Outcome
Title Change in Wolf Motor Function Test (WMFT), Timed Portion
Hide Description Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline
Time Frame baseline, post-intervention, 1-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects in the Sham PNS group were lost to follow-up.
Arm/Group Title Active PNS Sham PNS
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 10 9
Mean (95% Confidence Interval)
Unit of Measure: log(seconds)
Post-intervention minus baseline Number Analyzed 10 participants 9 participants
-0.36
(-0.45 to -0.27)
-0.18
(-0.28 to -0.07)
1-month follow-up minus baseline Number Analyzed 10 participants 7 participants
-0.37
(-0.51 to -0.22)
-0.15
(-0.29 to -0.01)
2.Secondary Outcome
Title Change in Fugl Meyer Assessment Motor Score
Hide Description Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline. The scores can range from 0 to 66, with higher scores indicating better performance. The scores are calculated by summing the scores to the 33 individual tasks.
Time Frame baseline, post-intervention, 1-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects from the Sham PNS group were lost to follow-up.
Arm/Group Title Active PNS Sham PNS
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 10 9
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Post-intervention minus baseline Number Analyzed 10 participants 9 participants
10.2
(7.44 to 12.96)
5.6
(2.34 to 8.77)
1-month follow-up minus baseline Number Analyzed 10 participants 7 participants
12.5
(7.52 to 17.48)
6.3
(2.96 to 9.61)
3.Secondary Outcome
Title Change in Action Research Arm Test (ARAT)
Hide Description

Values given are score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline.

The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement).

Performance on each item is rated on a 4-point ordinal scale ranging from:

3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty

1: Performs test partially 0: Can perform no part of test The maximum score on the ARTS is 57 points (possible range 0 to 57).

Time Frame baseline, post-intervention, 1-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects from the Sham PNS group were lost to follow-up.
Arm/Group Title Active PNS Sham PNS
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 10 9
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Post-intervention minus baseline
9.6
(5.64 to 13.57)
3.67
(2.28 to 5.05)
1-month follow-up minus baseline
11.1
(5.43 to 16.77)
4.43
(2.67 to 6.19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active PNS Sham PNS
Hide Arm/Group Description

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

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

All-Cause Mortality
Active PNS Sham PNS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active PNS Sham PNS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active PNS Sham PNS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      0/10 (0.00%)    
Injury, poisoning and procedural complications     
Fall [1]  1/11 (9.09%)  1 0/10 (0.00%)  0
[1]
Subject sustained a fall at home during the intervention period of the study. The subject was evaluated by a doctor not associated with the study and no fractures or major trauma was detected. The event was determined to not be related to the study.
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
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