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Neuromodulation
Electrical Stimulation for Cerebral Palsy
N/A
Recruiting
Led By Max J Kurz, PhD
Research Sponsored by Father Flanagan's Boys' Home
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Cerebral Palsy Participants: Gross Motor Function Classification score (GMFCS) levels between I-IV
Be younger than 65 years old
Must not have
For Cerebral Palsy Participants: No orthopedic surgery in the last 6 months or metal in their body that would preclude the use of an MRI
For Neurotypical Controls: No orthopedic surgery in the last 6 months or metal in their body that would preclude the use of an MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to study the differences in brain and spinal cord activity in individuals with cerebral palsy compared to those without. The study will also look at the effects of a type of electrical stimulation on brain
Who is the study for?
This trial is for individuals with Cerebral Palsy. It aims to understand and potentially improve how their brain and spinal cord work together. Participants should be able to undergo various non-invasive imaging tests like fMRI and MEG, as well as receive transcutaneous current stimulation.
What is being tested?
The study is testing whether applying a mild electrical current over the skin (transcutaneous current stimulation) can change brain and spinal cord activity in people with CP. It includes detailed assessments of these activities using advanced imaging techniques.
What are the potential side effects?
Transcutaneous current stimulation may cause discomfort or skin irritation at the site of application. Imaging procedures are generally safe but may require participants to remain still for extended periods.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cerebral palsy affects my movement but I can still move with or without aids.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had orthopedic surgery in the last 6 months and have no metal implants that would interfere with an MRI.
Select...
I haven't had orthopedic surgery in the last 6 months and have no metal implants that would interfere with an MRI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measure - Hoffman Reflex Assessments
Measure - MEG Brain Imaging
Measure - Transcutaneous Current Stimulation
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Neurotypical Youth/AdultsExperimental Treatment5 Interventions
Compared with the sham controls, those receiving the transcutaneous current stimulation will demonstrate alterations in the strength of the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence. Moreover, the extent of the alterations in the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence will be tightly linked with the clinical presentations of persons with CP.
Group II: Cerebral Palsy Youth/AdultsExperimental Treatment5 Interventions
Compared with the sham controls, those receiving the transcutaneous current stimulation will demonstrate alterations in the strength of the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence. Moreover, the extent of the alterations in the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence will be tightly linked with the clinical presentations of controls.
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Who is running the clinical trial?
Father Flanagan's Boys' HomeLead Sponsor
12 Previous Clinical Trials
1,528 Total Patients Enrolled
2 Trials studying Cerebral Palsy
184 Patients Enrolled for Cerebral Palsy
Max J Kurz, PhDPrincipal InvestigatorFather Flanagan's Boys' Home
4 Previous Clinical Trials
255 Total Patients Enrolled
3 Trials studying Cerebral Palsy
223 Patients Enrolled for Cerebral Palsy
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