taVNS‑paired constraint therapy with sTMS screening for infants with one‑sided weakness
Official title: Integrating Corticospinal Tract Assessment Via sTMS And taVNS-Augmented CIMT In Infants With Hemiplegia
Run by Medical University of South Carolina · NCT07063446 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 8 Months to 24 Months |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Status | Recruiting |
| Started | November 7, 2025 |
| Main results expected | October 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | November 26, 2025 |
| Trial ID | NCT07063446 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.