Skip to main content
OpenTrials
Completed

NCT Number: NCT05812794

TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Childhood Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

5 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants Who Complete the Study

    Time frame: 1-week post therapy

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

    Time frame: 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 outcomes

  1. Tolerability as Assessed by the Number of Patients That Endorse Any Side Effects as Documented on the Stimulation Monitoring Sheet

    Time frame: 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

  2. Tolerability as Assessed by the Number of Patients With Hypotension or Hypertension on Blood Pressure Monitoring

    Time frame: From baseline to 1 week post-therapy session

  3. Tolerability as Assessed by the Number of Patients With a Decrease in Score of 5 or Greater on the Peg-Board Test

    Time frame: 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.

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

    Time frame: 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.

  5. Change in Quality of Unilateral Upper Limb Movement as Assessed by the Melbourne Assessment of the Upper Extremity (MUUL)

    Time frame: 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

Other outcomes

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

    Time frame: 1 week post therapy

    The Pediatric Stroke Outcome Measure is a physician-administered rating scale of global function scored from 0 (no deficit) to 10 (profound deficit, immobile and non-responsive). Total score ranges from 0 to 10, with a higher score indicating a greater deficit in function.

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

    Time frame: 3 months post therapy

    The Pediatric Stroke Outcome Measure is a physician-administered rating scale of global function scored from 0 (no deficit) to 10 (profound deficit, immobile and non-responsive). Total score ranges from 0 to 10, with a higher score indicating a greater deficit in function.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Acronym: TOPSS

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 14, 2023
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.