N/A
N=10
Pediatric Teleneuromodulation
Cerebral Palsy (CP)
Bottom Line
View on ClinicalTrials.gov: NCT05071586 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Status/Safety Assessment — 4; 7; 20; 12 number of sessions symptom reported
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Soterix 1x1 tDCS LTE Stimulator Device Model 1401 (Device)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Status/Safety Assessment |
4; 7; 20; 12; 7; 2 | — |
| PRIMARY Change in tDCS Headgear Location |
0.9; 0.857; 1.125; 0.925; 0.675 | — |
| PRIMARY Step Difficulty Survey |
84; 16; 0; 0; 0; 74 | — |
| PRIMARY Responses to Comfort Survey |
9; 1; 0; 0; 8; 2 | — |
| SECONDARY Average Setup Time for Each Session |
530; 566; 622; 588; 548 | — |
| SECONDARY Change in Box and Blocks Assessment Score |
3; 0; 0.25; 1.75; -0.75; -2 | — |
Summary
This study will explore using remotely monitored 'active' non-invasive brain stimulation in children with cerebral palsy. Participants will receive active non-invasive brain stimulation with synchronous safety monitoring and guided instruction with laboratory staff after appropriate training. Participants will be between 8-21 years old and have a diagnosis of hemiparetic cerebral palsy with a history of a perinatal stroke or brain bleed, and can expect to be in the study for 5 days.
Eligibility Criteria
Inclusion Criteria
- 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
- Receptive language function to follow two-step commands
- Able to give informed assent along with the informed consent of the legal guardian. If the participant is 18-21 (with the capacity to consent), they must be able to give informed consent.
- Intentional about representing the sub-population of children with CP who experience intellectual disability (at least 2/10 participants with mild intellectual disabilities will be recruited)
- ≥ 10 degrees of active motion at the metacarpophalangeal joint
- Children who have had surgeries, which may influence motor function e.g.- tendon transfer, will be included, yet surgical history will be documented and included in any publication within a participant characteristics table.
Exclusion Criteria
- Inaccessibility to internet and a working computer/laptop/device.
- Implants
- Neoplasm
- Metabolic Disorders
- Epilepsy
- Seizure within two years preceding the study
- Acquired Traumatic Brain Injury
- Pregnancy
- Indwelling metal or incompatible medical devices
- Evidence of skin disease or skin abnormalities
- Botulinum toxin or Phenol block within [six-months] preceding the study
- Disorder of Cellular Migration and Proliferation
To be eligible for the optional 6-month/12-month follow-up:
- participants must have previously participated in the primary study
- have access to a reliable internet connection and a functioning computer, laptop, or mobile device.
- If participants become pregnant after participating in primary study, they may participate in the 6- and 12-month follow up sessions
Data sourced from ClinicalTrials.gov (NCT05071586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.