Clinical trial NCT05812794: TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors
Official title: TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Stroke
Keywords: neuromodulation
transcranial direct current stimulation
stroke
rehabilitation
childhood stroke
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 5
Sex: ALL
Minimum age (years): 5
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of Participants Who Complete the Study
timeFrame: 1-week post therapy
measure: Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function
timeFrame: 1 week post therapy
Secondary outcomes:
measure: Tolerability as Assessed by the Number of Patients That Endorse Any Side Effects as Documented on the Stimulation Monitoring Sheet
timeFrame: 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
measure: Tolerability as Assessed by the Number of Patients With Hypotension or Hypertension on Blood Pressure Monitoring
timeFrame: From baseline to 1 week post-therapy session
measure: Tolerability as Assessed by the Number of Patients With a Decrease in Score of 5 or Greater on the Peg-Board Test
timeFrame: Baseline, immediately post stimulation Day 5
measure: Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function
timeFrame: 3 month post therapy
measure: Change in Quality of Unilateral Upper Limb Movement as Assessed by the Melbourne Assessment of the Upper Extremity (MUUL)
timeFrame: Baseline,1 week post therapy , 3 months post therapy
Other outcomes:
measure: Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale
timeFrame: 1 week post therapy
measure: Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale
timeFrame: 3 months post therapy
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Stuart M Fraser, MD
role: PRINCIPAL_INVESTIGATOR
References: