8 Participants NeededMy employer runs this trial

CIMT + taVNS for Perinatal Brain Injury

BG
AK
Overseen ByArun Karumattu Manattu, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
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 study is for infants and toddlers between 8 and 24 months old who use one arm and/or hand differently following a perinatal brain injury. This is a time when investigators think they can best help improve how the brain controls movement. Investigators are testing whether the combination of transcutaneous auricular vagus nerve stimulation (taVNS) with 40 hours of constraint-induced movement therapy (CIMT) can help infants move their weaker arm and hand better and make the brain pathways for movement stronger.

Who Is on the Research Team?

BG

Bernadette Gillick, PhD, MSPT

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for infants and toddlers aged 8 to 24 months who have weakness in one arm or hand due to a brain injury around birth. They must not have had similar therapy recently, should be able to attend appointments over two weeks, and need follow-up after three months.

Inclusion Criteria

My infant has not had CIMT therapy in the last 3 months.
I can attend all study visits for 2 weeks and a 3-month follow-up.
My child is 8-24 months old and has weakness in one arm from a brain injury at birth.
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • Constraint-Induced Movement Therapy (CIMT)
  • Transcutaneous auricular vagus nerve stimulation (taVNS)

Trial Overview

Researchers are testing if combining gentle electrical stimulation of the ear (taVNS) with constraint-induced movement therapy (CIMT) helps young children improve use of their weaker arm and strengthens brain pathways for movement.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Infants and Toddlers with Perinatal Brain InjuryExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+