taVNS‑paired constraint therapy with sTMS screening for infants with one‑sided weakness
Integrating Corticospinal Tract Assessment Via sTMS And taVNS-Augmented CIMT In Infants With Hemiplegia
NA · Medical University of South Carolina · NCT07063446
This trial will test whether adding mild noninvasive vagus nerve stimulation to intensive one‑arm therapy helps infants 8–24 months with one‑sided weakness and whether a single brain stimulation pulse can predict who will benefit.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 8 Months to 24 Months |
| Sex | All |
| Sponsor | Medical University of South Carolina (other) |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT07063446 on ClinicalTrials.gov |
What this trial studies
The trial pairs transcutaneous vagus nerve stimulation (taVNS) with constraint induced movement therapy (CIMT) to try to boost motor recovery in infants with unilateral weakness after perinatal brain injury. Before the intervention, single‑pulse transcranial magnetic stimulation (sTMS) over motor cortex is used to record motor evoked potentials (MEPs) as a biomarker of corticospinal tract integrity and cortical excitability. Infants who receive taVNS‑paired CIMT will undergo a defined dosing schedule (about 40 hours of CIMT paired with taVNS) with outcomes measured acutely and at three months. The study is conducted at a single site with close, repeated in‑person visits during the two‑week intervention period.
Who should consider this trial
Good fit: Infants aged 8–24 months with asymmetric arm weakness or hemiplegia, GMFCS I–IV, whose families can attend consecutive intervention visits over two weeks and a three‑month follow‑up are ideal candidates.
Not a fit: Infants with severe global motor impairment (GMFCS V), uncontrolled seizures, significant uncorrected sensory deficits or cardiomyopathy, recent CIMT within three months, or quadriplegia are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this approach could accelerate hand and arm functional gains in infants with hemiplegia by enhancing the effects of CIMT.
How similar studies have performed: Small pilot studies and adult stroke rehabilitation research suggest taVNS can enhance motor training and sTMS‑elicited MEPs serve as useful motor biomarkers, but large, definitive evidence in infants with perinatal hemiplegia is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants 8-24mo with hemiplegia or asymmetric weakness of one arm, with or without truncal and transitional motor delays * Gross Motor function Classification system (GMFCS) I - IV * Parents are able to make consecutive appointments for assessments and intervention over 2wks and complete the 3mo follow-up. * Parents are willing to fill out developmental questionnaires and provide the study team feedback on tolerability and outcomes. Exclusion Criteria: * previous CIMT within 3 months * GMFCS V or severe motor impairment/quadriplegia * uncorrected blindness/deafness, cardiomyopathy * poorly controlled seizure disorder
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Dorothea Jenkins, MD
- Email: jenkd@mus.edu
- Phone: 843-792-2112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemiplegia, Perinatal Brain Injury, constraint induced movement therapy, infants, taVNS, sTMS, hemiplegia