10 Participants Needed

sTMS + taVNS for Hemiplegia

CD
DJ
Overseen ByDorothea Jenkins, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help infants with cerebral palsy or similar conditions where one arm is weaker. The treatment combines transcutaneous vagus nerve stimulation (taVNS), which activates specific brain circuits, with intense motor activities to enhance motor function. Additionally, the trial uses single-pulse transcranial magnetic stimulation (sTMS) to assess its potential in predicting which infants will benefit most from this therapy. The trial seeks infants aged 8–24 months who have noticeable weakness in one arm and can participate in a 2-week treatment program followed by a 3-month check-in.

As an unphased trial, this study offers infants a unique opportunity to potentially benefit from cutting-edge therapies and contribute to groundbreaking research.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this treatment is safe for infants with hemiplegia?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS), combined with specific motor exercises, can improve arm and hand movement in stroke recovery. One study found that taVNS boosts upper limb function, possibly by affecting brain activity on both sides.

Regarding safety, another study on taVNS for arm recovery after a stroke found no serious side effects, indicating that most people tolerate the treatment well.

Although specific data on using a combination of sTMS (a type of brain stimulation) and taVNS in infants is lacking, similar treatments in adults and animals have shown positive results without major safety issues. This suggests the treatment might be safe for infants, but more research is needed to confirm this.12345

Why are researchers excited about this trial?

Researchers are excited about the combination of sTMS (synchronized transcranial magnetic stimulation) and taVNS (transauricular vagus nerve stimulation) for treating hemiplegia because it offers a novel approach to rehabilitation. Unlike traditional therapies that primarily focus on physical rehabilitation exercises, this treatment targets the brain and nervous system directly. sTMS aims to stimulate brain activity, while taVNS works by activating the vagus nerve to enhance neuroplasticity. This dual approach could potentially accelerate recovery and improve motor function more effectively than current methods.

What evidence suggests that sTMS and taVNS are effective for hemiplegia?

Research has shown that a gentle nerve stimulation technique called transcutaneous vagus nerve stimulation (taVNS), combined with focused physical activities, can improve movement in infants with weakness on one side of the body, a common issue in early cerebral palsy. Studies have found that taVNS enhances movement therapy, leading to better use of the arms and hands. Similar treatments have improved upper body movement in stroke patients by increasing brain activity. Additionally, taVNS has reduced the size of brain damage and aided movement recovery in animals. In this trial, participants will receive sTMS with taVNS paired with CIMT. These findings suggest that taVNS, especially when combined with specific therapies, could benefit infants with brain injuries by improving their motor skills.12356

Are You a Good Fit for This Trial?

This trial is for infants with brain injuries leading to delayed motor skills and stronger development in one hand over the other, which may suggest early cerebral palsy. Infants who can potentially benefit from enhanced brain circuit function through specific treatments are eligible.

Inclusion Criteria

My child, aged 8-24 months, has weakness in one arm, possibly with other motor delays.
I have some level of physical disability but can perform some movements.
I can attend all appointments for 2 weeks and a follow-up after 3 months.
See 1 more

Exclusion Criteria

Previous CIMT within 3 months
I do not have uncorrected blindness, deafness, or heart muscle disease.
I have severe motor impairment or quadriplegia.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 40 hours of taVNS paired with CIMT treatment, with sTMS diagnostic testing performed before and after treatment

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • sTMS
  • taVNS
Trial Overview The study tests a combination of transcutaneous vagus nerve stimulation (taVNS) and constraint induced movement therapy (CIMT). It aims to determine if this pairing improves motor function in infants with hemiplegia by stimulating specific brain circuits.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: sTMS with taVNS paired CIMTExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

Citations

sTMS Combined With CIMT and taVNS In Infants ...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 ...
Transcutaneous auricular vagus nerve stimulation with task ...The combination of taVNS with TOT effectively improves upper extremity function in patients with subacute stroke, potentially through modulating the bilateral ...
efficacy observation of combined transcutaneous vagus ...The combination of transcutaneous auricular vagus nerve stimulation and transcranial direct current stimulation effectively enhances gait, balance, and daily ...
Effect of Combined Vagus Nerve Stimulation on Recovery ...VNS could reduce the size of infarcts and promote the recovery of UE motor function on acute or chronic outcomes in both young and elderly rats, according to ...
Transcutaneous auricular vagus nerve stimulation ...taVNS treatment improved PD motor symptoms by increasing Ne in the right M1 and enhancing intracortical facilitation (ICF, ISI 10, and 15 ms).
Closed-loop transcutaneous auricular vagus nerve ...Effect and safety of transcutaneous auricular Vagus nerve stimulation on recovery of upper limb motor function in subacute ischemic stroke ...
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