Non-invasive Vagus Nerve Stimulation for Cerebral Palsy

Overseen By Jenna Tosto Mancuso, PT, DPT,NCS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Investigational drugs

Disqualifiers: Vagus nerve injury, Schizophrenia, Bipolar, Cardiac arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 46 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help teenagers with spastic cerebral palsy improve arm and hand movement. The study tests a device that gently stimulates the vagus nerve, located in the ear, during physical therapy sessions. Known as non-invasive transcutaneous auricular Vagus Nerve Stimulation (taVNS), this method targets children aged 12 to 17 with spastic cerebral palsy who struggle with upper body movement. The trial aims to determine the safety of this method and its effectiveness in reducing motor impairments. As an unphased trial, it offers participants a unique opportunity to potentially benefit from an innovative therapy approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using any investigational drugs or have implanted stimulation devices, you may not be eligible to participate.

What prior data suggests that this non-invasive vagus nerve stimulation is safe for adolescents with cerebral palsy?

Research has shown that non-invasive ear-based vagus nerve stimulation (taVNS) is generally well-tolerated. Studies have used this treatment to aid recovery after a stroke, and taVNS showed promising results in improving movement abilities. No major safety issues were reported.

Additionally, individuals using similar stimulation methods for other treatments reported few side effects, which were usually mild, such as slight discomfort at the stimulation site. Since this trial focuses on safety and feasibility, researchers suggest that the treatment is likely safe for testing in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for cerebral palsy focus on physical therapy and medications to manage symptoms. Unlike these standard approaches, non-invasive transauricular vagus nerve stimulation (taVNS) offers a unique method by electrically stimulating the vagus nerve through the ear. This innovative delivery method is non-invasive, meaning it doesn't require surgery or implants, making it safer and more accessible. Researchers are excited about taVNS because it may enhance the benefits of physical therapy by directly influencing brain activity, potentially improving motor functions more effectively than current treatments.

What evidence suggests that this non-invasive VNS is effective for reducing motor impairment in spastic cerebral palsy?

Research has shown that a non-invasive treatment called transcutaneous auricular vagus nerve stimulation (taVNS), which participants in this trial will receive, might help improve motor skills in children with cerebral palsy. Studies have found that taVNS can enhance cognitive and motor development. Specifically, children with conditions like stroke and hemiplegic cerebral palsy (affecting one side of the body) have benefited from this treatment. Early findings suggest that taVNS positively affects the nervous system to support better motor function. These results are promising for reducing motor impairments in cerebral palsy. ^{3 4 6 7 8}

Who Is on the Research Team?

David Putrino, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

Adolescents aged 12-17 with spastic cerebral palsy can join this trial. They should be able to follow simple commands and have a certain level of hand function impairment. Those with previous vagus nerve injury, severe psychiatric conditions, progressive neurological diseases, heart issues, or using other stimulator devices cannot participate.

Inclusion Criteria

I have been diagnosed with spastic cerebral palsy.

Jebsen Taylor Hand Function Test Score of <37.08 on the affected side at time of screening visit (will be evaluated at screening)

I can understand and agree to the study's consent form.

Exclusion Criteria

Previous vagus nerve injury

I am either younger than 12 or older than 18.

Jebsen Taylor Hand Function Test Score of >37.08 on the affected side at time of screening visit (will be evaluated at screening)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive paired non-invasive vagus nerve stimulation (VNS) and upper extremity rehabilitation

46 days

Multiple therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Non-invasive taVNS

Trial Overview

The trial is testing non-invasive VNS paired with upper extremity rehabilitation to see if it helps improve motor skills in adolescents with spastic cerebral palsy. It's an early-stage study focusing on safety and how well the treatment works.

How Is the Trial Designed?

Group I: Non-invasive VNS Experimental Treatment 1 Intervention

Non-invasive, transauricular, vagus nerve stimulation device will be used during physical therapy rehabilitation sessions

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06880887

Nervus Vagus Stimulation and Cerebral Palsy

The aim of this study is to investigate the potential effects of vagus nerve stimulation, which is known to influence the autonomic nervous ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10666166/

Use of non-invasive transcutaneous auricular vagus nerve ...

The results of data from our cohort show comparable long-term neurodevelopmental outcomes in cognitive, receptive language, fine and gross motor ...

3.

frontiersin.org

frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2022.820665/full

Non-invasive Vagus Nerve Stimulation in Cerebral Stroke

These studies indicate that nVNS has promising efficacy in reducing stroke volume and attenuating neurological deficits in ischemic stroke models.

4.

mdpi.com

mdpi.com/1648-9144/61/5/872

Investigation of the Effectiveness of Transcutaneous ...

The aim of our study was to investigate the effect of transcutaneous auricular VNS (taVNS) on the vestibular symptoms of unilateral vestibular hypofunction ( ...

5.

medica-musc.researchcommons.org

medica-musc.researchcommons.org/cgi/viewcontent.cgi?article=1565&context=theses

Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)

Pertinently, these neuromodulations have shown even greater benefit in children with stroke and hemiplegic CP (Malone & Sun, 2019; Rubio et al., 2016). Page 26 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12821678/

Analysis of the Outcomes Studied in the Application of ... - PMC

The outcomes found were neuroprotection; motor, functional, and cognitive rehabilitation; dysphagia; comparison of different stimulation ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07394608

Paired Non-invasive VNS in Adolescent Cerebral Palsy ...

This is an open-label safety and feasibility trial evaluating the use of paired non-invasive vagus nerve stimulation (VNS) and upper extremity ( ...

8.

nature.com

nature.com/articles/s41598-023-42077-2

Effects and safety of vagus nerve stimulation on upper limb ...

The aim of this study is to carry out a systematic review and meta-analysis to determine its effects on motor function in patients with stroke.