Trial Outcomes & Findings for Extending taVNS Paired With Infant CIMT Into a Home-Based Setting (NCT NCT05857527)

Last Updated: 2025-07-04

Results Overview

Feasibility is measured as percent of total treatment time Electromyography (EMG) can successfully trigger stimulation during a Constraint induced movement therapy (CIMT) rehabilitation session.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

4 participants

Primary outcome timeframe

end of 4 week treatment intervention (40 hours of CIMT)

Results posted on

2025-07-04

Participant Flow

Recruitment occurred through flyers in the local hospital and clinics. Flyers were provided to high-risk infant follow-up clinics to be distributed to eligible parents.

All participants received 40 hours of CIMT paired with taVNS. The first 2 participants received treatment in the lab so the engineer could address sensor calibration and settings to automate EMG triggering. The remaining participants received the same 40 hours of CIMT paired with taVNS in the home setting with the goal to test feasibility of translation of the new EMG triggered taVNS into standard home therapy settings. Participants were told if they would be in home or lab before consent.

Participant milestones

Participant milestones
Measure	Custom EMG Triggered Soterix taVNS Stimulation With CIMT Therapy in Lab Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 1 will occur in the lab, and ongoing notifications will be made to the EMG system to test the feasibility of automatic stimulation	Custom EMG Triggered Soterix taVNS Stimulation With CIMT Therapy in Home Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 2 will occur in the home and will assess the quality of the CIMT therapy provided with the automated EMG system.
Overall Study STARTED	2	2
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Custom EMG Triggered Soterix taVNS Stimulation With CIMT Therapy in Lab Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 1 will occur in the lab, and ongoing notifications will be made to the EMG system to test the feasibility of automatic stimulation	Custom EMG Triggered Soterix taVNS Stimulation With CIMT Therapy in Home Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 2 will occur in the home and will assess the quality of the CIMT therapy provided with the automated EMG system.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Extending taVNS Paired With Infant CIMT Into a Home-Based Setting

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: end of 4 week treatment intervention (40 hours of CIMT)

Feasibility is measured as percent of total treatment time Electromyography (EMG) can successfully trigger stimulation during a Constraint induced movement therapy (CIMT) rehabilitation session.

Outcome measures

Outcome measures
Measure	Custom EMG Triggered Soterix taVNS Stimulation With CIMT Therapy in Lab n=2 Participants Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 1 will occur in the lab, and ongoing notifications will be made to the EMG system to test feasibility of automatic stimulation	Custom EMG Triggered Soterix taVNS Stimulation With CIMT Therapy in Home Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 2 will occur in the home and will assess the quality of the CIMT therapy provided with the automated EMG system.
Device Feasibility	33.33 percent time EMG taVNS stimulation Interval 3.0 to 77.0	—

SECONDARY outcome

Timeframe: end of 4 week treatment intervention (40 hours of CIMT)

Population: Even though we met the threshold to move to trialing the EMG triggered taVNS in home we faced technical issues with the EMG triggering interface. We completed the full 40 hours of CIMT therapy but could not use EMG triggered taVNS stimulation. Therefore, we were not able to rate the fidelity of the CIMT treatment with TMG triggered taVNS because the EMG system did not function properly. Our 2nd participant withdrew and therefore, we were again not able to rate the fidelity of implementation.

Fidelity Rating of Quality of Constraint Induced Movement Therapy Delivery while using the experimental EMG triggered Soterix taVNS stimulator. Fidelity of Implementation Measure (FIRM) which describes how consistently therapists exhibit behaviors consistent with CIMT principles and operant conditioning techniques and are rated on a scale of 1-4. A 4 being consistently demonstrating with less than 1 exception, and 1 being rarely or not at all. A score of 3 indicates acceptable to high fidelity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change in functional motor outcome completed pre and post 40 hours of treatment

Population: We completed analysis on the 3 participants who received 40 hours of CIMT therapy paired with taVNS. The 2nd participant in the home group withdrew and did not complete the 40 hours of therapy so change in function was not assessed.

Quality of Upper Extremity Skills Test The QUEST is a criterion-referenced measure designed to evaluate the quality of upper extremity function in young children with spasticity. We calculated scores from 2 domains:1) Dissociated movement and2) Grasp Item scores are summed; formulas are used to calculate percentages for each domain. Domain percentages are summed and divided by number of domains (2 for our study) to obtain total score. Minimum score = 0; Maximum score = 100 The total QUEST score was calculated by summing scores for each sub-domain tested divided by the total number of sub-domains tested. The total scores on the QUEST range from 0 to 100. Higher scores represent better quality of movement.

Outcome measures

Outcome measures
Measure	Custom EMG Triggered Soterix taVNS Stimulation With CIMT Therapy in Lab n=2 Participants Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 1 will occur in the lab, and ongoing notifications will be made to the EMG system to test feasibility of automatic stimulation	Custom EMG Triggered Soterix taVNS Stimulation With CIMT Therapy in Home n=1 Participants Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 2 will occur in the home and will assess the quality of the CIMT therapy provided with the automated EMG system.
Quality of Upper Extremity Skills Test (QUEST)	14.8 score on a scale Interval 8.01 to 21.59	24.89 score on a scale Interval 24.89 to 24.89

Adverse Events

Soterix taVNS Stimulation Using EMG Sensors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kelly McGloon

Medical University of South Carolina

Phone: 8437926443

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Custom EMG Triggered Soterix taVNS Stimulation With CIMT Therapy in Lab n=2 Participants Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 1 will occur in the lab, and ongoing notifications will be made to the EMG system to test feasibility of automatic stimulation	Custom EMG Triggered Soterix taVNS Stimulation With CIMT Therapy in Home n=2 Participants Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 2 will occur in the home and will assess the quality of the CIMT therapy provided with the automated EMG system.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	18.5 months n=5 Participants	22.5 months n=7 Participants	20.5 months n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Gross Motor Functional Measure (GMFM) function at baseline	36 Gross Motor Functional Measure 66 score n=5 Participants	31.5 Gross Motor Functional Measure 66 score n=7 Participants	33.75 Gross Motor Functional Measure 66 score n=5 Participants