HemiplegiaNCT07063446
sTMS Combined With CIMT and taVNS In Infants With Hemiplegia
A study testing sTMS and taVNS in people with Hemiplegia and Perinatal Brain Injury, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Preterm and term infants with brain injury frequently have delayed motor skills, and one hand and arm may become stronger than the other, which can signal early cerebral palsy. A new treatment, transcutaneous vagus nerve stimulation (taVNS), boosts specific brain circuits and may improve function when paired with… Read more about this study
- Who is it for?
- Ages 8 to 24 months
- Conditions the study is for
- Hemiplegia, Perinatal Brain Injury
- What is being tested?
- sTMS and taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- previous CIMT within 3 months
- GMFCS V or severe motor impairment/quadriplegia
- uncorrected blindness/deafness, cardiomyopathy
- poorly controlled seizure disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Dorothea Jenkins, MD, 843-792-2112, jenkd@msuc.edu
Cynthia Dodds, PhD PT
About this study
Official title: Integrating Corticospinal Tract Assessment Via sTMS And taVNS-Augmented CIMT In Infants With Hemiplegia
Preterm and term infants with brain injury frequently have delayed motor skills, and one hand and arm may become stronger than the other, which can signal early cerebral palsy. A new treatment, transcutaneous vagus nerve stimulation (taVNS), boosts specific brain circuits and may improve function when paired with intensive motor activities. This study will test taVNS-paired constraint induced movement therapy in infants who have greater weakness on one side and determine if a single pulse of transcranial brain stimulation over the motor area can cause a measurable movement of the hand or thumb, and indicate which infants can benefit from 40h taVNS-paired CIMT.
Read the detailed description
One of the most effective early therapies for improving motor skills in infants with unilateral motor weakness after perinatal brain injury, is constraint induced movement therapy (CIMT), in which a therapist engages a child in targeted play therapy with the more-affected arm/hand while the less-affected arm is immobilized in a mitt, reinforcing activity-dependent neuroplasticity. taVNS may accelerate functional gains and boost CIMT effects in young infants with hemiplegia over CIMT alone, based on pilot data. Before embarking on a larger scale trial, single pulse transcranial magnetic stimulation (sTMS) will be used to determine the connectivity and strength of the cortical spinal tract motor circuit with motor evoked potential of the hand or thumb.
The hypothesis is that the ability to respond to taVNS paired with intensive motor skill therapy in hemiplegic infants may be predicted by motor evoked potentials (MEP) elicited from sTMS over the motor cortex, as a quantifiable biomarker of CST circuit integrity, circuit response and cortical excitability.
- Conditions
- Hemiplegia, Perinatal Brain Injury
- Being tested
- sTMS, taVNS
- Keywords
- constraint induced movement therapy, infants, taVNS, sTMS, hemiplegia
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sTMSDevice
Single pulses of TMS will be delivered over the motor cortex to quantify and map the motor evoked potentials
taVNSDevice
Also called transcutaneous auricular vagus nerve stimulation
taVNS will be used to stimulate the auricular branch of the vagus nerve and paired with CIMT for a total of 40hours of CIMT
| Study group | Role | What they receive |
|---|---|---|
| sTMS with taVNS paired CIMT | Experimental | sTMS diagnostic testing will be performed before and after 40hours of taVNS paired with CIMT treatment Receives: Device: sTMS; Device: taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assisted Hand Assessment
Percent Change in the mini-AHA or AHA from baseline to end of treatment- the standardized scale on the Assisted hand assessments range from 0-100 where 100 indicates greatest possible functional use of the hand and 0 indicates no hand function
Measured: 3months
Motor Evoked Potential (MEP)
Presence or absence (+ or -) of MEP in the affected upper extremity in response to sTMS of primary motor cortex in both hemispheres (circuit analysis)
Measured: 3 months
Secondary outcomes (1)
GMFM-88
Percent Change in scores of Gross motor function measure-88 from baseline to end of treatment; total raw scores range from 0-264, with higher scores indicating greater motor function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start7 Nov 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The trial is designed to use a diagnostic device prior to using an experimental treatment device paired with non-experimental physical therapy (CIMT).
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorothea Jenkins, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063446
- Sponsor's protocol ID
- Pro00146198
- Status last verified
- Nov 2025
- First submitted
- 3 Jul 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Videotapes of motor skills assessments are identifiable PHI and will not be shared. Extracted, de-identifed data may be shared on request.
Publications
Sutter EN, Casey CP, Gillick BT. Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury. Expert Rev Med Devices. 2024 Mar;21(3):179-186. doi: 10.1080/17434440.2023.2299310. Epub 2024 Jan 3.
PubMed 38166497Casey CP, Sutter EN, Grimaldo A, Collins KM, Guerrero-Gonzalez J, McAdams RM, Dean DC 3rd, Gillick BT. Preservation of Bilateral Corticospinal Projections from Injured Hemisphere After Perinatal Stroke. Brain Sci. 2025 Jan 17;15(1):82. doi: 10.3390/brainsci15010082.
PubMed 39851449McGloon K, Humanitzki E, Brennan J, Summers P, Brennan A, George MS, Badran BW, Cribb AR, Jenkins D, Coker-Bolt P. Pairing taVNS and CIMT is feasible and may improve upper extremity function in infants. Front Pediatr. 2024 Feb 13;12:1365767. doi: 10.3389/fped.2024.1365767. eCollection 2024.
PubMed 38415207
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Corticospinal Tract Assessment Via sTMS And taVNS-Augmented CIMT In Infants With Hemiplegia
- ClinicalTrials.gov ID
- NCT07063446
- Acronym / sponsor ID
- Pro00146198
- Conditions
- Hemiplegia, Perinatal Brain Injury
- Keywords
- constraint induced movement therapy, infants, taVNS, sTMS, hemiplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm and term infants with brain injury frequently have delayed motor skills, and one hand and arm may become stronger than the other, which can signal early cerebral palsy. A new treatment, transcutaneous vagus nerve stimulation (taVNS), boosts specific brain circuits and may improve function when paired with intensive motor activities. This study will test taVNS-paired constraint induced movement therapy in infants who have greater weakness on one side and determine if a single pulse of transcranial brain stimulation over the motor area can cause a measurable movement of the hand or thumb, and indicate which infants can benefit from 40h taVNS-paired CIMT.
Detailed description
One of the most effective early therapies for improving motor skills in infants with unilateral motor weakness after perinatal brain injury, is constraint induced movement therapy (CIMT), in which a therapist engages a child in targeted play therapy with the more-affected arm/hand while the less-affected arm is immobilized in a mitt, reinforcing activity-dependent neuroplasticity. taVNS may accelerate functional gains and boost CIMT effects in young infants with hemiplegia over CIMT alone, based on pilot data. Before embarking on a larger scale trial, single pulse transcranial magnetic stimulation (sTMS) will be used to determine the connectivity and strength of the cortical spinal tract motor circuit with motor evoked potential of the hand or thumb.
The hypothesis is that the ability to respond to taVNS paired with intensive motor skill therapy in hemiplegic infants may be predicted by motor evoked potentials (MEP) elicited from sTMS over the motor cortex, as a quantifiable biomarker of CST circuit integrity, circuit response and cortical excitability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The trial is designed to use a diagnostic device prior to using an experimental treatment device paired with non-experimental physical therapy (CIMT).
| Arm | Type | Receives |
|---|---|---|
| sTMS with taVNS paired CIMT | Experimental | Device: sTMS, Device: taVNSsTMS diagnostic testing will be performed before and after 40hours of taVNS paired with CIMT treatment |
Who may qualify
- Ages
- 8 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- previous CIMT within 3 months
- GMFCS V or severe motor impairment/quadriplegia
- uncorrected blindness/deafness, cardiomyopathy
- poorly controlled seizure disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sTMSSingle pulses of TMS will be delivered over the motor cortex to quantify and map the motor evoked potentials | Device | sTMS with taVNS paired CIMT |
| taVNSAlso: transcutaneous auricular vagus nerve stimulationtaVNS will be used to stimulate the auricular branch of the vagus nerve and paired with CIMT for a total of 40hours of CIMT | Device | sTMS with taVNS paired CIMT |
Primary outcome
Assisted Hand Assessment
Time frame: 3months
Percent Change in the mini-AHA or AHA from baseline to end of treatment- the standardized scale on the Assisted hand assessments range from 0-100 where 100 indicates greatest possible functional use of the hand and 0 indicates no hand function
Motor Evoked Potential (MEP)
Time frame: 3 months
Presence or absence (+ or -) of MEP in the affected upper extremity in response to sTMS of primary motor cortex in both hemispheres (circuit analysis)
1 secondary outcome
GMFM-88
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background: PubMed 38166497Sutter EN, Casey CP, Gillick BT. Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury. Expert Rev Med Devices. 2024 Mar;21(3):179-186. doi: 10.1080/17434440.2023.2299310. Epub 2024 Jan 3.
- Background: PubMed 39851449Casey CP, Sutter EN, Grimaldo A, Collins KM, Guerrero-Gonzalez J, McAdams RM, Dean DC 3rd, Gillick BT. Preservation of Bilateral Corticospinal Projections from Injured Hemisphere After Perinatal Stroke. Brain Sci. 2025 Jan 17;15(1):82. doi: 10.3390/brainsci15010082.
- Background: PubMed 38415207McGloon K, Humanitzki E, Brennan J, Summers P, Brennan A, George MS, Badran BW, Cribb AR, Jenkins D, Coker-Bolt P. Pairing taVNS and CIMT is feasible and may improve upper extremity function in infants. Front Pediatr. 2024 Feb 13;12:1365767. doi: 10.3389/fped.2024.1365767. eCollection 2024.
- Individual participant dataSharing planned: No. Videotapes of motor skills assessments are identifiable PHI and will not be shared. Extracted, de-identifed data may be shared on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sTMS and taVNS in people with Hemiplegia and Perinatal Brain Injury, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorothea Jenkins, MD (843-792-2112, jenkd@mus.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assisted Hand Assessment (time frame: 3months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07063446, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.