Trial Outcomes & Findings for TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors (NCT NCT05812794)

NCT ID: NCT05812794

Last Updated: 2024-09-26

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

1-week post therapy

Results posted on

2024-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcranial Direct Current Stimulation (tDCS) n=5 Participants 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.
Age, Continuous	15 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Age at stroke	10.1 years STANDARD_DEVIATION 7.14 • n=5 Participants
Type of Stroke Intracranial Hemorrhage	2 Participants n=5 Participants
Type of Stroke Arterial Ischemic	3 Participants n=5 Participants
Arm affected left arm affected	3 Participants n=5 Participants
Arm affected right arm affected	2 Participants n=5 Participants
Number of participants with history of seizures at stroke presentation	4 Participants n=5 Participants
Number of participants with a diagnosis of epilepsy	2 Participants n=5 Participants
Number of prescribed antiepileptics	1 Number of prescribed antiepileptics STANDARD_DEVIATION 1.22 • n=5 Participants
Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale	2 score on a scale n=5 Participants
Stroke Etiology Aneurysm Rupture	1 Participants n=5 Participants
Stroke Etiology Traumatic Dissection	1 Participants n=5 Participants
Stroke Etiology Meningitis and Disseminated Intravascular Coagulation	1 Participants n=5 Participants
Stroke Etiology Focal Cerebral Arteriopathy	1 Participants n=5 Participants
Stroke Etiology Complication of Cerebral Arteriovenous Malformation Embolization	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-week post therapy

Outcome measures

Outcome measures
Measure	Transcranial Direct Current Stimulation (tDCS) n=5 Participants 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.
Number of Participants Who Complete the Study	5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Transcranial Direct Current Stimulation (tDCS) n=5 Participants 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.
Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function	41 score on a scale Interval 38.0 to 43.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Transcranial Direct Current Stimulation (tDCS) n=5 Participants 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.
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
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
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
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
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 outcome

Timeframe: From baseline to 1 week post-therapy session

Outcome measures

Outcome measures
Measure	Transcranial Direct Current Stimulation (tDCS) n=5 Participants 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.
Tolerability as Assessed by the Number of Patients With Hypotension or Hypertension on Blood Pressure Monitoring	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Transcranial Direct Current Stimulation (tDCS) n=5 Participants 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.
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 outcome

Timeframe: 3 month post therapy

Outcome measures

Outcome measures
Measure	Transcranial Direct Current Stimulation (tDCS) n=5 Participants 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.
Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function	42 score on a scale Interval 37.0 to 44.0

SECONDARY outcome

Timeframe: Baseline,1 week post therapy , 3 months post therapy

Population: Data were not collected for this outcome measure.

This assessment has a total score range of 0-100% a higher score indicating better outcome

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Transcranial Direct Current Stimulation (tDCS) n=5 Participants 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.
Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale	2 score on a scale Interval 1.0 to 4.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months post therapy

Outcome measures

Outcome measures
Measure	Transcranial Direct Current Stimulation (tDCS) n=5 Participants 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.
Global Function as Assessed by Score on the Pediatric Stroke Outcome Measure (PSOM) Rating Scale	2 score on a scale Interval 1.0 to 4.0

Adverse Events

Transcranial Direct Current Stimulation (tDCS)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Transcranial Direct Current Stimulation (tDCS) n=5 participants at risk 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.
General disorders Itchiness	100.0% 5/5 • 3 months
General disorders Tingling	40.0% 2/5 • 3 months
General disorders Unusual feelings on skin of head	20.0% 1/5 • 3 months
General disorders Sleepiness	40.0% 2/5 • 3 months
Ear and labyrinth disorders Change in hearing	20.0% 1/5 • 3 months

Additional Information

Stuart Mason Fraser, MD

The University of Texas Health Science Center at Houston

Phone: 713-500-7142

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place