N/A N=20 Randomized Double-blind Basic Science

Single-session tDCS in Cerebral Palsy

Cerebral Palsy · Perinatal Stroke · Periventricular Leukomalacia

Bottom Line

View on ClinicalTrials.gov: NCT03635775 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Change in Motor Evoked Potential Amplitude — 12.4; 81.7; -34.4 percent change

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active tDCS (Device); Sham tDCS (Device)
Age: Pediatric, Adult · 7+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Motor Evoked Potential Amplitude	12.4; 81.7; -34.4	—
SECONDARY Change in Movement Accuracy	-5.67; -40; -28.2	—

Summary

The goal of this study is to characterize individual responses to a single application of transcranial direct current stimulation (tDCS) in children with unilateral cerebral palsy (UCP), and to test which electrode configuration produces changes in brain excitability and motor function. Participants with UCP, ages 7-21 years, will be assigned to one of four tDCS groups. Using single-pulse transcranial magnetic stimulation, the investigators will assess cortical excitability before and at regular intervals up to 1 hour following tDCS. The knowledge gained from this study will advance the field through more targeted approaches of neuromodulatory techniques in this population and others, using individual characteristics to guide optimal treatment

Eligibility Criteria

Inclusion Criteria (for all participants):

Ages 7-21
Able to follow two-step commands.
Presence of an MEP in the non-lesioned hemisphere

Exclusion Criteria (for all participants):

Evidence of seizure within 2 years
Other neurological or metabolic conditions
Is pregnant (females only)
Presence of indwelling metal in the head (e.g. aneurysm clip) or medical device.

Inclusion Criteria (for participants with cerebral palsy):

Clinical diagnosis of unilateral cerebral palsy
Radiological evidence of stroke or periventricular leukomalacia

Exclusion Criteria(for participants with cerebral palsy):

Treatment with injectable agents (e.g. Botox) for spasticity management within 2 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03635775). 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.