Trial Outcomes & Findings for CIMT and taVNS for Hemiplegia in Infants (NCT NCT05101707)
NCT ID: NCT05101707
Last Updated: 2025-06-13
Results Overview
Feasibility of delivering high fidelity CIMT therapy sessions while the therapist is also triggering taVNS using the Fidelity of Implementation Measure (FIRM) with scoring range (0-4), higher scores indicate greater consistency of therapy with established CIMT procedure
COMPLETED
EARLY_PHASE1
6 participants
at 1 month
2025-06-13
Participant Flow
We recruited participants from referrals from neonatal high risk development clinic, and referral from other rehab professionals seeing patients in their clinics from June 1, 2021 to July 30, 2024.
open label study without a washout period. all participants were receiving physical and occupational therapy for hemiplegia
Participant milestones
| Measure |
CIMT + taVNS
The investigators will deliver taVNS paired with 40h of Constraint Induced Movement Therapy for unilateral weakness/hemiplegia
transcutaneous auricular vagus nerve stimulation: Applying a pulsed microcurrent to the auricular branch of the vagus nerve, timed with motor activity of the weaker arm/hand
Constraint induced movement therapy: Applying a custom-made splint constraint to the stronger hand/arm to encourage use of the weaker hand/arm in intensive therapy sessions
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CIMT and taVNS for Hemiplegia in Infants
Baseline characteristics by cohort
| Measure |
Open Label taVNS Paired With 40 Hours CIMT
n=6 Participants
infants with hemiplegia receive taVNs paired with constraint induced movement therapy for a total of 40h, 2h a day 5 days a week for 4 weeks
|
|---|---|
|
Age, Continuous
|
16.7 months of age
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: at 1 monthFeasibility of delivering high fidelity CIMT therapy sessions while the therapist is also triggering taVNS using the Fidelity of Implementation Measure (FIRM) with scoring range (0-4), higher scores indicate greater consistency of therapy with established CIMT procedure
Outcome measures
| Measure |
Open Label taVNS Paired With 40 Hours CIMT
n=3 Participants
infants with hemiplegia receive taVNs paired with constraint induced movement therapy for a total of 40h, 2h a day 5 days a week for 4 weeks
|
|---|---|
|
CIMT Fidelity
|
3.76 score on a scale
Interval 3.58 to 3.76
|
PRIMARY outcome
Timeframe: 1 monthPopulation: entire group (n=6) received 40h of CIMT with taVNS
change in test of hand function and quality of movement between the right and left sides of the body, scoring range 0-100, higher scores indicate better hand function; from baseline to end of treatment
Outcome measures
| Measure |
Open Label taVNS Paired With 40 Hours CIMT
n=6 Participants
infants with hemiplegia receive taVNs paired with constraint induced movement therapy for a total of 40h, 2h a day 5 days a week for 4 weeks
|
|---|---|
|
Quality of Upper Extremity Skills Test (QUEST), GRASP
|
209 percentage of change from baseline
Standard Deviation 161
|
SECONDARY outcome
Timeframe: 1 monthPopulation: entire group that received 40h of CIMT paired with taVNS
The Gross Motor Function Measure-88 (GMFM-88) assessment tool includes 88 items, each receiving a score from 0 to 3 (0 = does not initiate; 1 = initiates; 2 = partially completes; 3 = completes). Items span the spectrum of gross motor activities in five dimensions: A: Lying and Rolling (17 items), B: Sitting (20 items), C: Crawling and Kneeling (14 items), D: Standing (13 items), E: Walking, Running, Jumping (24 items). Every dimension score is expressed with a percentage. All dimension scores are then averaged to a total GMFM-88 percentage score, which is an estimate of the participant's gross motor function (0 = low motor function; 100 = high motor function).
Outcome measures
| Measure |
Open Label taVNS Paired With 40 Hours CIMT
n=6 Participants
infants with hemiplegia receive taVNs paired with constraint induced movement therapy for a total of 40h, 2h a day 5 days a week for 4 weeks
|
|---|---|
|
Gross Motor Function Measure-88 (GMFM-88)
|
32 units on a scale
Standard Deviation 28
|
Adverse Events
CIMT + taVNS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Dorothea Jenkins
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place