Cerebral Palsy (CP) Clinical Trial
Official title:
Remotely Monitored Transcranial Direct Current Stimulation in Children With Cerebral Palsy
Verified date | June 2023 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 21 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Status/Safety Assessment | Before stimulation, the study team will work with the participant to fill out a status survey. In the survey, participants will be asked to report the severity of events they may experience. Since investigators are working with the pediatric population, the investigator makes the final decision on the likelihood of an event being related to the tDCS intervention versus the participant's environment. Serious adverse events, falling in the 3-5 categories (1-unrelated, 2- unlikely, 3- possible, 4- probable, 5- definite) will be considered related to the study. This determination is made with the parent/caregiver as witnesses and confirmed by the parent/caregiver. | Baseline - Day 1 | |
Primary | Status/Safety Assessment | During stimulation, the study team will work with the participant to fill out a status survey. In the survey, participants will be asked to report the severity of events they may experience. Since investigators are working with the pediatric population, the investigator makes the final decision on the likelihood of an event being related to the tDCS intervention versus the participant's environment. Serious adverse events, falling in the 3-5 categories (1-unrelated, 2- unlikely, 3- possible, 4- probable, 5- definite) will be considered related to the study. This determination is made with the parent/caregiver as witnesses and confirmed by the parent/caregiver. | During stimulation on days 2-5 | |
Primary | Status/Safety Assessment | After stimulation, the study team will work with the participant to fill out a status survey. In the survey, participants will be asked to report the severity of events they may experience. Since investigators are working with the pediatric population, the investigator makes the final decision on the likelihood of an event being related to the tDCS intervention versus the participant's environment. Serious adverse events, falling in the 3-5 categories (1-unrelated, 2- unlikely, 3- possible, 4- probable, 5- definite) will be considered related to the study. This determination is made with the parent/caregiver as witnesses and confirmed by the parent/caregiver. | Posttest on sessions 2, 3, 4, and 5 | |
Primary | 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 | |
Primary | Change in responses to ease of set up survey | To evaluate the feasibility of remotely monitored-tDCS, the difficulty of each step will be measured on an ordinal 3-point scale. A lower score will correspond with a lower difficulty setting. Average difficulty will be compared throughout all sessions to indicate any improvement throughout the study. | Post sessions on day 1, 2, 3, 4 , and 5 | |
Primary | Change in responses to comfort survey | To evaluate the comfort of the device, participants will be asked a question on an ordinal 4-point scale. A lower score corresponds with a higher comfortability. | Post sessions on day 1, 2, 3, 4 , and 5, optional 6 month follow up, optional 12 month follow up | |
Primary | Medical Record Review at 6 months | To assess medical status and the potential for new onset seizures, development of epilepsy, changes in motor function, and development of long-lasting symptons since participation in the primary study. | Optional 6 month follow up | |
Primary | Medical Record Review at 12 months | To assess medical status and the potential for new onset seizures, development of epilepsy, changes in motor function, and development of long-lasting symptons since participation in the primary study. | Optional 12 month follow up | |
Primary | Change in tDCS Subject Report of Symptoms Questionnaire | Summary table of symptoms participant has experienced since the primary study. | optional 6 and 12 month follow up | |
Primary | Change in Qualitative tDCS Tolerance Survey | Qualitative analysis to compare the participants feedback regarding the tDCS. | optional 6 and 12 month follow up | |
Primary | Change in Gross Motor Function Classification System | The gross motor function of children and young people with cerebral palsy is categorized into 5 different levels: Level 1 is the most independent movement (child can run and jump) to Level 5, the most dependent (transported in a manual wheelchair, for example) | baseline, optional 6 and 12 month follow up | |
Secondary | Change in time to complete montage setup | To evaluate speed of device setup, time to complete montage set up will be measured. On the REDCap (Research Electronic Data Capture) survey, the researcher will click a "now" button that records the time to seconds at the beginning and end of montage set up. The lower time corresponds to ease in montage set up. |
Pre-stimulation on day 1, 2, 3, 4 and 5 | |
Secondary | Change in contact quality (CQ) | SMARTscan™ contact quality is reported by the device throughout the stimulation and reflects quality of the stimulation delivery. Lower contact quality indicates the stimulation isn't being properly delivered. Changes in stimulation quality over the three active sessions using a Friedman test (non-parametric test for repeated measures) will be determined. Tests with a p-value of <0.05 will be considered significant. | Post stimulation on day 1, 2, 3, 4 and 5 | |
Secondary | Change in Box and Blocks assessment score | To evaluate the potential change in motor function, the Box and Blocks score will be measured before and after each active session. Motor function is not hypothesized to change due to the limited trials of active tDCS. | Post sessions on day 2, 3, 4 , and 5, optional 6 month follow up, optional 12 month follow up |
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