N/A
N=5
TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors
Childhood Stroke
Bottom Line
View on ClinicalTrials.gov: NCT05812794 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants Who Complete the Study — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Direct Current Stimulation (tDCS) (Device)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Complete the Study |
5 | — |
| PRIMARY Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function |
42 | — |
| SECONDARY Tolerability as Assessed by the Number of Patients That Endorse Any Side Effects as Documented on the Stimulation Monitoring Sheet |
4; 2; 2; 1; 2 | — |
| SECONDARY Tolerability as Assessed by the Number of Patients With Hypotension or Hypertension on Blood Pressure Monitoring |
— | — |
| SECONDARY Tolerability as Assessed by the Number of Patients With a Decrease in Score of 5 or Greater on the Peg-Board Test |
— | — |
| SECONDARY Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function |
42 | — |
| SECONDARY Change in Quality of Unilateral Upper Limb Movement as Assessed by the Melbourne Assessment of the Upper Extremity (MUUL) |
— | — |
Summary
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05812794). 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.