Adults 8 to 21, any sex, with Cerebral Palsy (CP). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Status/Safety AssessmentPrimary· Active Stimulation Sessions (20 min), 3 days total
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.
Headache
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
4
Unusual Feelings on Skin of Head
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
7
Tingling
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
20
Itchiness
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
12
Sleepiness
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
7
Difficulty paying attention
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
2
Unusual Emotions
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
1
Tooth Pain
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
1
Change in tDCS Headgear LocationPrimary· Post sessions on day 1, 2, 3, 4 , and 5
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.
Day 1
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
0.9
0.5 – 2
Day 2
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
0.857
0.25 – 2
Day 3
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
1.125
0.25 – 2
Day 4
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
0.925
0.2 – 1.5
Day 5
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
0.675
0.2 – 1
Step Difficulty SurveyPrimary· Average over 5 days
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
Step 1: Very Easy
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
84
Step 1: Easy
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
16
Step 1: Neural
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
0
Step 1: Difficult
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
0
Step 1: Very Difficult
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
0
Step 2: Very Easy
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
74
Step2: Easy
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
20
Step 2: Neutral
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
6
Responses to Comfort SurveyPrimary· Post sessions on day 1, 2, 3, 4 , and 5
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
Day 1: Comfortable
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
9
Day 1: Slightly uncomfortable
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
1
Day 1: Uncomfortable but tolerable
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
0
Day 1: Very uncomfortable, and I had to remove it
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
0
Day 2: Comfortable
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
8
Day 2: Slightly uncomfortable
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
2
Day 2: Uncomfortable but tolerable
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
0
Day 2: Very uncomfortable, and I had to remove it
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
0
Average Setup Time for Each SessionSecondary· Pre-stimulation on day 1, 2, 3, 4 and 5
To evaluate speed of device setup, time to complete montage set up will be measured and averaged among participants.
Day 1
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
530
312 – 691
Day 2
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
566
352 – 858
Day 3
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
622
360 – 1008
Day 4
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
588
239 – 1195
Day 5
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
548
249 – 1027
Change in Box and Blocks Assessment ScoreSecondary· Post sessions on day 2, 3, 4 , and 5
To evaluate the potential change in motor function, the Box and Blocks score will be measured before and after each active session. This is a timed motor assessment, the score is the number of blocks successfully moved over a partition in one minute, a higher score indicates greater hand function. Lower scores indicate lower hand function.
The reported outcome measure describes the change over each session in the Box and Blocks score.
Motor function is not hypothesized to change due to the limited trials of active tDCS.
Session 2: dominant hand
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
3
± 2.48
Session 2: non- dominant hand
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
0
± 3.81
Session 3: dominant hand
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
0.25
± 4.75
Session 3: non-dominant
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
1.75
± 2.28
Session 4: dominant hand
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
-0.75
± 4.70
Session 4: non-dominant hand
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
-2
± 1.60
Session 5: dominant hand
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
2.25
± 2.40
Session 5: non-dominant hand
Group
Value
95% CI
Children Diagnosed With Stroke/Brain Bleed
1.5
± 3.02
Adverse events — posted to ClinicalTrials.gov
Time frame: The adverse event survey was collected each study sham and active study visit day (day 2, 3, 4,5) before stimulation, during simulation at the 10 minute mark, and post stimulation..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Wisconsin, Madison
Last refreshed: 7 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05071586.