← Back to Search

Neuromodulation

Teleneuromodulation for Cerebral Palsy

N/A

Waitlist Available

Led By Bernadette Gillick, PhD, MSPT

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged between 8 years 0 days and 21 years 365 days

Children who have hemiparetic cerebral palsy with a history of perinatal brain bleed/stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up optional 6 and 12 month follow up

Awards & highlights

Study Summary

This trialexplores using monitored brain stimulation to help children with cerebral palsy. 8-17 year olds with a history of stroke or bleed can participate for 5 days.

Who is the study for?

This trial is for children and young adults aged 8-21 with hemiparetic cerebral palsy due to perinatal stroke or brain bleed. They must have some movement in their fingers, be able to follow instructions, and give consent (or assent with guardian consent). Those with mild intellectual disabilities are also encouraged to join. Excluded are individuals without internet access, metal implants, recent seizures, certain medical conditions or treatments.Check my eligibility

What is being tested?

The study tests a non-invasive brain stimulation device called Soterix 1x1 tDCS LTE Stimulator Model 1401 on children with cerebral palsy. It involves remote monitoring over five days of 'active' stimulation while participants interact with lab staff online after training.See study design

What are the potential side effects?

While the description doesn't specify side effects, similar non-invasive brain stimulation may cause discomfort at the electrode site, headache, fatigue or nausea. Serious side effects are rare but can include seizure or skin irritation under the electrodes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 8 and 21 years old.

Select...

My child has cerebral palsy due to a brain bleed or stroke at birth.

Select...

I can move my finger joints more than 10 degrees.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ optional 6 and 12 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~optional 6 and 12 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and optional 6 and 12 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Gross Motor Function Classification System

Change in Qualitative tDCS Tolerance Survey

Change in responses to comfort survey

+6 more

Secondary outcome measures

Change in Box and Blocks assessment score

Change in contact quality (CQ)

Change in time to complete montage setup

Trial Design

1Treatment groups

Experimental Treatment

Group I: Children diagnosed with stroke/brain bleedExperimental Treatment1 Intervention

Male and females aged 8 to 21 with established diagnosis of stroke/brain bleed who are US residents.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,183 Previous Clinical Trials

3,167,544 Total Patients Enrolled

1 Trials studying Cerebral Palsy

60 Patients Enrolled for Cerebral Palsy

Bernadette Gillick, PhD, MSPTPrincipal InvestigatorUniversity of Wisconsin, Madison

1 Previous Clinical Trials

65 Total Patients Enrolled

Media Library

Cerebral Palsy Research Study Groups: Children diagnosed with stroke/brain bleed

Cerebral Palsy Clinical Trial 2023: Soterix 1x1 tDCS LITE Stimulator Device Model 1401 Highlights & Side Effects. Trial Name: NCT05071586 — N/A

Soterix 1x1 tDCS LITE Stimulator Device Model 1401 (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05071586 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals 40 years or older eligible to participate in the experiment?

"This trial is specifically tailored to 8 to 17 year-olds, with 135 studies acceptable for those below the age of majority and 26 trials appropriate for seniors."

Answered by AI

Is this research initiative still open to participants?

"Clinicaltrials.gov affirms that this medical experiment is actively recruiting volunteers to partake in the trial, with its initial posting being on December 21st 2022 and a subsequent update occurring on January 12th 2023."

Answered by AI

How many volunteers have signed up for this research initiative?

"Right. This clinical trial, which was launched on December 21st 2022, is currently recruiting participants and its details were updated as recently as January 12th 2023. So far it has collected data from 10 patients at one medical facility."

Answered by AI

What are the end goals of this research endeavor?

"This trial's primary purpose is to observe the alteration of tdcs headgear placement over a predetermined amount of time. Secondary objectives include an assessment of montage set-up times using REDCap (Research Electronic Data Capture) survey, changes in stimulation quality via SMARTscan™ contact quality readings, and a Box and Blocks test to evaluate potential improvements in motor function. Friedman tests will be used to determine if any shifts occur with p value results lower than 0.05 being deemed significant."

Answered by AI

What criteria must an individual meet in order to take part in this research?

"This clinical trial is recruiting 10 minors with cerebral palsy between the ages of 8 and 17. Eligibility criteria include having receptive language capability to follow two-step commands, as well as capacity for informed assent alongside parental consent. Other requirements are hemiparetic CP related to a pre-birth brain bleed/stroke, at least 10 degrees of active movement in the metacarpophalangeal joint, mild mental disability in no fewer than 2 participants, and any surgical history that may impact motor function documented for publication purposes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pediatric Teleneuromodulation

2022. "Pediatric Teleneuromodulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05071586.

All > Cerebral Palsy