TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors
- Conditions
- Childhood Stroke
- Interventions
- Device: Transcranial Direct Current Stimulation (tDCS)
- Registration Number
- NCT05812794
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transcranial Direct Current Stimulation (tDCS) Transcranial Direct Current Stimulation (tDCS) -
- Primary Outcome Measures
Name Time Method Number of Participants Who Complete the Study 1-week post therapy Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function 1 week post therapy Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. Total score ranges from 0 to 66, with a higher score indicating greater arm function.
- Secondary Outcome Measures
Name Time Method Tolerability as Assessed by the Number of Patients That Endorse Any Side Effects as Documented on the Stimulation Monitoring Sheet immediately post stimulation Day 1, immediately post stimulation Day 2, immediately post stimulation Day 3, immediately post stimulation Day 4, immediately post stimulation Day 5 Tolerability as Assessed by the Number of Patients With Hypotension or Hypertension on Blood Pressure Monitoring From baseline to 1 week post-therapy session Tolerability as Assessed by the Number of Patients With a Decrease in Score of 5 or Greater on the Peg-Board Test Baseline, immediately post stimulation Day 5 The peg-board test is scored from 0 to 50, with the score indicating the number of pegs placed correctly into the board using the affected hand. A higher score indicates a better outcome, and a decrease in score over time indicates worsening of functioning over time. The number of participants with a decrease in score of 5 or greater on the peg-board test is reported.
Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function 3 month post therapy Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. Total score ranges from 0 to 66, with a higher score indicating greater arm function.
Change in Quality of Unilateral Upper Limb Movement as Assessed by the Melbourne Assessment of the Upper Extremity (MUUL) Baseline,1 week post therapy , 3 months post therapy This assessment has a total score range of 0-100% a higher score indicating better outcome
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States