Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale | 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. | 1 week post therapy |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stuart M Fraser, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40836943 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial Direct Current Stimulation (tDCS) | Transcranial Direct Current Stimulation (tDCS): 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial Direct Current Stimulation (tDCS) | Transcranial Direct Current Stimulation (tDCS): 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Complete the Study | Posted | Count of Participants | Participants | 1-week post therapy |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcranial Direct Current Stimulation (tDCS) | Transcranial Direct Current Stimulation (tDCS): 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itchiness | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stuart Mason Fraser, MD | The University of Texas Health Science Center at Houston | 713-500-7142 | Stuart.M.Fraser@uth.tmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2023 | Aug 19, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 | 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. | Baseline, immediately post stimulation Day 5 |
| 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. | 3 month post therapy |
| 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 | Baseline,1 week post therapy , 3 months post therapy |
| Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale | 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. | 3 months post therapy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Age at stroke | Mean | Standard Deviation | years |
|
| Type of Stroke | Count of Participants | Participants |
|
| Arm affected | Count of Participants | Participants |
|
| Number of participants with history of seizures at stroke presentation | Count of Participants | Participants |
|
| Number of participants with a diagnosis of epilepsy | Count of Participants | Participants |
|
| Number of prescribed antiepileptics | Mean | Standard Deviation | Number of prescribed antiepileptics |
|
| Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale | 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. | Median | Full Range | score on a scale |
|
| Stroke Etiology | Count of Participants | Participants |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 1 week post therapy |
|
|
|
| Secondary | Tolerability as Assessed by the Number of Patients That Endorse Any Side Effects as Documented on the Stimulation Monitoring Sheet | Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | Tolerability as Assessed by the Number of Patients With Hypotension or Hypertension on Blood Pressure Monitoring | Posted | Count of Participants | Participants | From baseline to 1 week post-therapy session |
|
|
|
| Secondary | Tolerability as Assessed by the Number of Patients With a Decrease in Score of 5 or Greater on the Peg-Board Test | 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. | Posted | Count of Participants | Participants | Baseline, immediately post stimulation Day 5 |
|
|
|
| Secondary | 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. | Posted | Mean | Inter-Quartile Range | score on a scale | 3 month post therapy |
|
|
|
| Secondary | 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 | Data were not collected for this outcome measure. | Posted | Baseline,1 week post therapy , 3 months post therapy |
|
|
| Other Pre-specified | Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale | 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. | Posted | Median | Full Range | score on a scale | 1 week post therapy |
|
|
|
| Other Pre-specified | Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale | 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. | Posted | Median | Full Range | score on a scale | 3 months post therapy |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
| Tingling | General disorders | Systematic Assessment |
|
| Unusual feelings on skin of head | General disorders | Systematic Assessment |
|
| Sleepiness | General disorders | Systematic Assessment |
|
| Change in hearing | Ear and labyrinth disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| Title | Measurements |
|---|---|
|
| immediately post stimulation Day 4 |
|
| immediately post stimulation Day 5 |
|