TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors

NCT05812794 | Completed Results FDA Device

• 1 other identifier: HSC-MS-23-0092
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Childhood Stroke

Keywords

neuromodulation; transcranial direct current stimulation; stroke; rehabilitation; childhood stroke

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Complete the Study

  1-week post therapy

• Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function

  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.

  1 week post therapy

Secondary Outcomes (5)

• 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

• Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function

  3 month post therapy

• 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

Other Outcomes (2)

• Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale

  1 week post therapy

• Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale

  3 months post therapy

Study Arms (1)

Transcranial Direct Current Stimulation (tDCS)

EXPERIMENTAL

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

Participants will come for 5 sequential days of 2 hour long occupational therapy sessions augmented by tDCS for the first 20 minutes of the session. At arrival, the "stimulation safety sheet" will be completed by the occupational therapist.The saline soaked electrodes will be placed on the study subjects head and connected to the Soterix 1x1 Limited Total Energy (LTE) enabled tDCS device. Current output through the device will be sham stimulation on day 1 , followed by steady increases to a maximum of 1milliampere (mA) in patients aged 5-12 years old, and 1.5 mA in patients aged 13-19 years old, per the study design flow sheet at the end of this protocol. Blood pressure, pulse rate, and peg-board scores will be recorded as indicated on the stimulation safety sheet during each session.A repeat assessment will be done by the occupational therapist one week post therapy completion.There will be a repeat assessment visit 3 months post intervention.

Transcranial Direct Current Stimulation (tDCS)

Eligibility Criteria

• Age: 5 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Fraser S, Clearman A, Abrahams M, Gillick B, Lal T, Savitz S, Yozbatiran N. TOPSS: TOlerability of transcranial direct current stimulation in Pediatric Stroke Survivors. Front Hum Neurosci. 2025 Aug 5;19:1629499. doi: 10.3389/fnhum.2025.1629499. eCollection 2025.

  PMID: 40836943 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Stuart Mason Fraser, MD
• Organization: The University of Texas Health Science Center at Houston

Stuart.M.Fraser@uth.tmc.edu

713-500-7142

Study Officials

• Stuart M Fraser, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 14, 2023
• Study Start: June 30, 2023
• Primary Completion: December 11, 2023
• Study Completion: March 15, 2024
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)