Pediatric Teleneuromodulation

NCT05071586 | Completed Results DMC FDA Device

• 3 other identifiers: 2021-0691Protocol ver 8 5/4/2023Development Pediatrics
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy (CP)

Keywords

Children with cerebral palsy; Remote transcranial direct current stimulation (tDCS); Non-invasive brain stimulation (NIBS)

Outcome Measures

Primary Outcomes (4)

• Status/Safety Assessment

  Participants were asked to fill out an adverse event survey during active stimulation. Reported below are responses from the participants to the survey regardless of potential relation to stimulation.

  Active Stimulation Sessions (20 min), 3 days total

• Change in tDCS Headgear Location

  To evaluate the quality of device setup, we will measure any changes or movement of the headgear. To do this, we will mark the starting and ending location of the headgear and measure the distance between the two. It will be reported if the headgear moved in any participants and the average displacement.

  Post sessions on day 1, 2, 3, 4 , and 5

• Step Difficulty Survey

  To evaluate the feasibility of remotely monitored-tDCS, participants were asked how difficult the setup instructions were to understand on a 5 point scale (Very easy, easy, slightly difficult, very difficult, impossible). Set up instruction consisted of 6 steps, participants were asked to rate the steps each day. Results are reported as overall percentage of difficulty rating over 5 days

  Average over 5 days

• Responses to Comfort Survey

  To evaluate the comfort of the device, participants will be asked how comfortable was wearing the headgear on a 4 point scale(Comfortable, Slightly uncomfortable, Uncomfortable but tolerable, Very uncomfortable, and I had to remove it) Result reported as total over the 5 day participation in study

  Post sessions on day 1, 2, 3, 4 , and 5

Secondary Outcomes (2)

• Average Setup Time for Each Session

  Pre-stimulation on day 1, 2, 3, 4 and 5

• Change in Box and Blocks Assessment Score

  Post sessions on day 2, 3, 4 , and 5

Study Arms (1)

Children diagnosed with stroke/brain bleed

EXPERIMENTAL

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

Device: Soterix 1x1 tDCS LTE Stimulator Device Model 1401

Interventions

Soterix 1x1 tDCS LTE Stimulator Device Model 1401 DEVICE

Participants will receive 20 minutes of 1.5 mA (Milliampere) transcranial direct current stimulation (tDCS) via Soterix 1x1 tDCS LTE Stimulator Device Model 1401 with a bilateral M1 montage.

Children diagnosed with stroke/brain bleed

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (3)

• Lench DH, Simpson E, Sutter EN, Gillick BT. Feasibility of remote transcranial direct current stimulation for pediatric cerebral palsy during the COVID-19 pandemic. Brain Stimul. 2020 Nov-Dec;13(6):1803-1804. doi: 10.1016/j.brs.2020.10.010. Epub 2020 Oct 23. No abstract available.

  PMID: 33132132 BACKGROUND

• Christopher P, Sutter EN, Gavioli M, Lench DH, Nytes G, Mak V, Simpson EA, Ikonomidou C, Villegas MA, Saiote C, Gillick BT. Safety, tolerability and feasibility of remotely-instructed home-based transcranial direct current stimulation in children with cerebral palsy. Brain Stimul. 2023 Sep-Oct;16(5):1325-1327. doi: 10.1016/j.brs.2023.08.024. Epub 2023 Aug 29. No abstract available.

  PMID: 37652136 DERIVED

• Simpson EA, Saiote C, Sutter E, Lench DH, Ikonomidou C, Villegas MA, Gillick BT. Remotely monitored transcranial direct current stimulation in pediatric cerebral palsy: open label trial protocol. BMC Pediatr. 2022 Sep 29;22(1):566. doi: 10.1186/s12887-022-03612-8.

  PMID: 36175848 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Bernadette Gillick
• Organization: University of Wisconsin - Madison

bgillick@wisc.edu

608-381-2699

Study Officials

• Bernadette Gillick, PhD, MSPT

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 8, 2021
• Study Start: December 21, 2022
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: May 7, 2024
• Results First Posted: May 7, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)