Trial Outcomes & Findings for Driving Neuroplasticity With Nerve Stimulation and Modified CIT (NCT NCT02587234)

NCT ID: NCT02587234

Last Updated: 2023-09-13

Results Overview

Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: baseline, post-intervention, 1-month follow-up
• Results posted on: 2023-09-13

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	11	10
Overall Study COMPLETED	10	7
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	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
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

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.

Baseline characteristics by cohort

Measure	Active PNS n=11 Participants 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 n=10 Participants 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 n=21 Participants Total of all reporting groups
Age, Continuous	56.7 years STANDARD_DEVIATION 8.6 • n=10 Participants • 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.	54.6 years STANDARD_DEVIATION 10.2 • n=9 Participants • 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.	55.7 years STANDARD_DEVIATION 9.2 • n=19 Participants • 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 Female	7 Participants n=10 Participants • Numbers do not include the 2 subjects who withdrew prior to completing the interventions.	3 Participants n=9 Participants • Numbers do not include the 2 subjects who withdrew prior to completing the interventions.	10 Participants n=19 Participants • Numbers do not include the 2 subjects who withdrew prior to completing the interventions.
Sex: Female, Male Male	3 Participants n=10 Participants • Numbers do not include the 2 subjects who withdrew prior to completing the interventions.	6 Participants n=9 Participants • Numbers do not include the 2 subjects who withdrew prior to completing the interventions.	9 Participants n=19 Participants • Numbers do not include the 2 subjects who withdrew prior to completing the interventions.

PRIMARY outcome

Timeframe: baseline, post-intervention, 1-month follow-up

Population: Two subjects in the Sham PNS group were lost to follow-up.

Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline

Outcome measures

Measure	Active PNS n=10 Participants 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 n=9 Participants 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
Change in Wolf Motor Function Test (WMFT), Timed Portion Post-intervention minus baseline	-0.36 log(seconds) Interval -0.45 to -0.27	-0.18 log(seconds) Interval -0.28 to -0.07
Change in Wolf Motor Function Test (WMFT), Timed Portion 1-month follow-up minus baseline	-0.37 log(seconds) Interval -0.51 to -0.22	-0.15 log(seconds) Interval -0.29 to -0.01

SECONDARY outcome

Timeframe: baseline, post-intervention, 1-month follow-up

Population: Two subjects from the Sham PNS group were lost to follow-up.

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.

Outcome measures

Measure	Active PNS n=10 Participants 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 n=9 Participants 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
Change in Fugl Meyer Assessment Motor Score Post-intervention minus baseline	10.2 units on a scale Interval 7.44 to 12.96	5.6 units on a scale Interval 2.34 to 8.77
Change in Fugl Meyer Assessment Motor Score 1-month follow-up minus baseline	12.5 units on a scale Interval 7.52 to 17.48	6.3 units on a scale Interval 2.96 to 9.61

SECONDARY outcome

Timeframe: baseline, post-intervention, 1-month follow-up

Population: Two subjects from the Sham PNS group were lost to follow-up.

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).

Outcome measures

Measure	Active PNS n=10 Participants 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 n=9 Participants 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
Change in Action Research Arm Test (ARAT) Post-intervention minus baseline	9.6 units on a scale Interval 5.64 to 13.57	3.67 units on a scale Interval 2.28 to 5.05
Change in Action Research Arm Test (ARAT) 1-month follow-up minus baseline	11.1 units on a scale Interval 5.43 to 16.77	4.43 units on a scale Interval 2.67 to 6.19

Adverse Events

Active PNS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham PNS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active PNS n=11 participants at risk 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 n=10 participants at risk 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
Injury, poisoning and procedural complications Fall	9.1% 1/11 • Number of events 1	0.00% 0/10

Additional Information

Lumy Sawaki, MD, PhD

University of Kentucky

Email: lumy.sawaki@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place