search
Back to results

TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors (TOPSS)

Primary Purpose

Childhood Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Stroke focused on measuring neuromodulation, transcranial direct current stimulation, stroke, rehabilitation, childhood stroke

Eligibility Criteria

5 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Direct Current Stimulation (tDCS)

Arm Description

Outcomes

Primary Outcome Measures

Percent of patients who complete the study
Improvement of arm function as assessed by the Fugl-Meyer score of Upper extremity function (increase of 5 points or more)
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. The total possible scale score is 66

Secondary Outcome Measures

Change in tolerability as assessed by the percent of patients that endorse mild side effects as documented on the stimulation monitoring sheet
Change in tolerability as assessed by the percent of patients with hypotension or hypertension on blood pressure monitoring
Change in tolerability as assessed by the percent of patients with worsening of the Peg-board test (decreased score by 5 or greater) on the Peg-Board Test
Peg-board is scored from 0 to 50, as the number of pegs placed correctly into the board using the affected hand a higher number indicating better outcome
Improvement of arm function as assessed by the Fugl-Meyer score of Upper extremity function (increase of 5 points or more)
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. The total possible scale score is 66
Change in quality of unilateral upper limb movement as assessed by the Melbourne Assessment of the Upper Extremity (MUUL)
This assessment has a total score range of 0-100% a higher score indicating better outcome

Full Information

First Posted
March 30, 2023
Last Updated
August 3, 2023
Sponsor
The University of Texas Health Science Center, Houston
search

1. Study Identification

Unique Protocol Identification Number
NCT05812794
Brief Title
TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors
Acronym
TOPSS
Official Title
TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Stroke
Keywords
neuromodulation, transcranial direct current stimulation, stroke, rehabilitation, childhood stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation (tDCS)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Intervention Description
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 Outcome Measure Information:
Title
Percent of patients who complete the study
Time Frame
1-week post therapy
Title
Improvement of arm function as assessed by the Fugl-Meyer score of Upper extremity function (increase of 5 points or more)
Description
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. The total possible scale score is 66
Time Frame
1 week post therapy
Secondary Outcome Measure Information:
Title
Change in tolerability as assessed by the percent of patients that endorse mild side effects as documented on the stimulation monitoring sheet
Time Frame
pre and immediately post stimulation Day1,pre and immediately post stimulation Day 2, pre and immediately post stimulation Day 3,pre and immediately post stimulation Day 4, pre and immediately post stimulation Day 5
Title
Change in tolerability as assessed by the percent of patients with hypotension or hypertension on blood pressure monitoring
Time Frame
pre and immediately post stimulation Day1,pre and immediately post stimulation Day 2, pre and immediately post stimulation Day 3,pre and immediately post stimulation Day 4, pre and immediately post stimulation Day 5, 1 week post-therapy session
Title
Change in tolerability as assessed by the percent of patients with worsening of the Peg-board test (decreased score by 5 or greater) on the Peg-Board Test
Description
Peg-board is scored from 0 to 50, as the number of pegs placed correctly into the board using the affected hand a higher number indicating better outcome
Time Frame
Baseline,immediately post stimulation Day1, immediately post stimulation Day 2, immediately post stimulation Day 3,immediately post stimulation Day 4, immediately post stimulation Day 5
Title
Improvement of arm function as assessed by the Fugl-Meyer score of Upper extremity function (increase of 5 points or more)
Description
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. The total possible scale score is 66
Time Frame
3 month post therapy assessment
Title
Change in quality of unilateral upper limb movement as assessed by the Melbourne Assessment of the Upper Extremity (MUUL)
Description
This assessment has a total score range of 0-100% a higher score indicating better outcome
Time Frame
Baseline,1 week post therapy , 3 month post therapy assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stuart M Fraser, MD
Phone
713-500-7142
Email
Stuart.M.Fraser@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Melika Abrahams
Phone
713-500-6138
Email
Melika.A.Abrahams@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart M Fraser, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart M Fraser
Phone
713-500-7142
Email
Stuart.M.Fraser@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Melika Abrahams
Phone
713-500-6138
Email
Melika.A.Abrahams@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors

We'll reach out to this number within 24 hrs