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TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors (TOPSS)

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Childhood Stroke

Treatments

Device: Transcranial Direct Current Stimulation (tDCS)

Study type

Interventional

Funder types

Other

Identifiers

NCT05812794
HSC-MS-23-0092

Details and patient eligibility

About

The purpose of this study is to evaluate the tolerability of tDCS in childhood stroke survivors and to assess for improvement in arm function in patients receiving tDCS and occupational therapy

Enrollment

5 patients

Sex

All

Ages

5 to 19 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Childhood stroke survivor - either arterial ischemic stroke or intracerebral hemorrhage.
  • Stroke must be childhood onset, defined as occurring day 29 of life to 18 years of age (per the American Heart Association's definition of childhood stroke)
  • 3 months or greater from stroke onset
  • Arm impairment, defined as pediatric stroke outcome measure of 1 or greater of affected arm.
  • Affected arm Fugl-Meyer score of 60 or lower.
  • Able to participate in occupational therapy sessions.

Exclusion criteria

  • Uncontrolled epilepsy, defined as seizure within the past 6 months.
  • Craniectomy without replacement of bone flap. Patients who underwent craniectomy will need the bone flap reattached prior to participation.
  • Presence of cranial metal implants or implant device that could be affected by tDCS: cochlear implant, implanted brain stimulator, or programmable ventriculoperitoneal shunt.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

Transcranial Direct Current Stimulation (tDCS)
Experimental group
Treatment:
Device: Transcranial Direct Current Stimulation (tDCS)

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Melika Abrahams; Stuart M Fraser, MD

Data sourced from clinicaltrials.gov

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