Childhood Stroke
Conditions
Keywords
neuromodulation, transcranial direct current stimulation, stroke, rehabilitation, childhood stroke
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
Interventions
DEVICETranscranial 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 19 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function | 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. |
| Number of Participants Who Complete the Study | 1-week post therapy | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | This assessment has a total score range of 0-100% a higher score indicating better outcome |
| Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function | 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. |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Transcranial Direct Current Stimulation (tDCS) | — |
|---|---|---|
| Age at stroke | 10.1 years STANDARD_DEVIATION 7.14 | — |
| Age, Continuous | 15 years | — |
| Arm affected left arm affected | 3 Participants | — |
| Arm affected right arm affected | 2 Participants | — |
| Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale | 2 score on a scale | — |
| Number of participants with a diagnosis of epilepsy | 2 Participants | — |
| Number of participants with history of seizures at stroke presentation | 4 Participants | — |
| Number of prescribed antiepileptics | 1 Number of prescribed antiepileptics STANDARD_DEVIATION 1.22 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 5 participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
| Stroke Etiology Aneurysm Rupture | 1 Participants | — |
| Stroke Etiology Complication of Cerebral Arteriovenous Malformation Embolization | 1 Participants | — |
| Stroke Etiology Focal Cerebral Arteriopathy | 1 Participants | — |
| Stroke Etiology Meningitis and Disseminated Intravascular Coagulation | 1 Participants | — |
| Stroke Etiology Traumatic Dissection | 1 Participants | — |
| Type of Stroke Arterial Ischemic | 3 Participants | — |
| Type of Stroke Intracranial Hemorrhage | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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.
Time frame: 1 week post therapy
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function | 41 score on a scale |
Primary
Number of Participants Who Complete the Study
Time frame: 1-week post therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Number of Participants Who Complete the Study | 5 Participants |
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.
Time frame: 3 month post therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function | 42 score on a scale |
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
Time frame: Baseline,1 week post therapy , 3 months post therapy
Population: Data were not collected for this outcome measure.
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | 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 | 4 Participants |
| Transcranial Direct Current Stimulation (tDCS) | Tolerability as Assessed by the Number of Patients That Endorse Any Side Effects as Documented on the Stimulation Monitoring Sheet | immediately post stimulation Day 2 | 2 Participants |
| Transcranial Direct Current Stimulation (tDCS) | Tolerability as Assessed by the Number of Patients That Endorse Any Side Effects as Documented on the Stimulation Monitoring Sheet | immediately post stimulation Day 3 | 2 Participants |
| Transcranial Direct Current Stimulation (tDCS) | Tolerability as Assessed by the Number of Patients That Endorse Any Side Effects as Documented on the Stimulation Monitoring Sheet | immediately post stimulation Day 4 | 1 Participants |
| Transcranial Direct Current Stimulation (tDCS) | Tolerability as Assessed by the Number of Patients That Endorse Any Side Effects as Documented on the Stimulation Monitoring Sheet | immediately post stimulation Day 5 | 2 Participants |
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.
Time frame: Baseline, immediately post stimulation Day 5
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Tolerability as Assessed by the Number of Patients With a Decrease in Score of 5 or Greater on the Peg-Board Test | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Tolerability as Assessed by the Number of Patients With Hypotension or Hypertension on Blood Pressure Monitoring | 0 Participants |
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.
Time frame: 1 week post therapy
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale | 2 score on a scale |
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.
Time frame: 3 months post therapy
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale | 2 score on a scale |