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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 pre-stimulation on day 1, 2, 3, 4 and 5
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
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I am between 8 and 21 years old.
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My child has cerebral palsy due to a brain bleed or stroke at birth.
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I can move my finger joints more than 10 degrees.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post sessions on day 1, 2, 3, 4 , and 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and post sessions on day 1, 2, 3, 4 , and 5 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 tDCS Headgear Location
Responses to Comfort Survey
Status/Safety Assessment
+1 more
Secondary outcome measures
Average Setup Time for Each Session
Change in Box and Blocks Assessment Score

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Soterix 1x1 tDCS LTE Stimulator Device Model 1401
2022
N/A
~10

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,193 Previous Clinical Trials
3,161,859 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
~4 spots leftby May 2025
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