Single-arm, open-label, dose escalation phase i study to evaluate the safety and feasibility of transcranial direct current stimulation with electroencephalography biomarkers in paediatric disorders of consciousness

A study protocol

Research output: Contribution to journalArticle

Abstract

Introduction Children with disorders of consciousness (DOC) represent the highest end of the acquired brain injury (ABI) severity spectrum for survivors and experience a multitude of functional impairments. Current clinical management in DOC uses behavioural evaluation measures and interventions that fail to (1) describe the physiological consequences of ABI and (2) elicit functional gains. In paediatric DOC, there is a critical need to develop evidence-based interventions to promote recovery of basic responses to improve rehabilitation and aid decision-making for medical teams and caregivers. The purpose of this investigation is to examine the safety, tolerability and feasibility of transcranial direct current stimulation (tDCS) in children with DOC. Methods and analysis This study is an open-label dose escalation trial evaluating the safety, tolerability and feasibility of tDCS in 10 children (5-17 years) receiving inpatient rehabilitation for DOC. This study will follow a modified rule-based design, allowing for intrapatient escalation, where a cohort of patients will be assigned to an initial tDCS current of 0.5 or 1 mA based on participant's head circumference and according to the safety data available in other paediatric populations. The subsequent assignment of increased current (1 or 2 mA) according to the prespecified rules will be based on the clinical observation of adverse events in the patients. The study will include up to three, 20 min sessions of anodal tDCS (sham, 0.5 or 1 mA, 1 or 2 mA) applied over the dorsolateral prefrontal cortex. The primary outcomes are adverse events, pain associated with tDCS and intolerable disruption of inpatient care. Secondary outcomes are changes in electroencephalography (EEG) phase-locking and event-related potential components and the Coma Recovery Scale-Revised total score from prestimulation to poststimulation. Ethics and dissemination The Johns Hopkins IRB (#IRB00174966) approved this study. Trial results will be disseminated through journals and conferences. Registration number NCT03618849.

Original languageEnglish (US)
Article numbere029967
JournalBMJ open
Volume9
Issue number8
DOIs
StatePublished - Aug 1 2019

Fingerprint

Consciousness Disorders
Electroencephalography
Biomarkers
Pediatrics
Safety
Brain Injuries
Inpatients
Rehabilitation
Research Ethics Committees
Coma
Prefrontal Cortex
Evoked Potentials
Ethics
Caregivers
Survivors
Head
Observation
Transcranial Direct Current Stimulation
Pain
Population

Keywords

  • brain injuries
  • child
  • electroencephalography
  • tDCS
  • transcranial direct current stimulation

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{7a3fd27a5c924aad83e482959a2b7f01,
title = "Single-arm, open-label, dose escalation phase i study to evaluate the safety and feasibility of transcranial direct current stimulation with electroencephalography biomarkers in paediatric disorders of consciousness: A study protocol",
abstract = "Introduction Children with disorders of consciousness (DOC) represent the highest end of the acquired brain injury (ABI) severity spectrum for survivors and experience a multitude of functional impairments. Current clinical management in DOC uses behavioural evaluation measures and interventions that fail to (1) describe the physiological consequences of ABI and (2) elicit functional gains. In paediatric DOC, there is a critical need to develop evidence-based interventions to promote recovery of basic responses to improve rehabilitation and aid decision-making for medical teams and caregivers. The purpose of this investigation is to examine the safety, tolerability and feasibility of transcranial direct current stimulation (tDCS) in children with DOC. Methods and analysis This study is an open-label dose escalation trial evaluating the safety, tolerability and feasibility of tDCS in 10 children (5-17 years) receiving inpatient rehabilitation for DOC. This study will follow a modified rule-based design, allowing for intrapatient escalation, where a cohort of patients will be assigned to an initial tDCS current of 0.5 or 1 mA based on participant's head circumference and according to the safety data available in other paediatric populations. The subsequent assignment of increased current (1 or 2 mA) according to the prespecified rules will be based on the clinical observation of adverse events in the patients. The study will include up to three, 20 min sessions of anodal tDCS (sham, 0.5 or 1 mA, 1 or 2 mA) applied over the dorsolateral prefrontal cortex. The primary outcomes are adverse events, pain associated with tDCS and intolerable disruption of inpatient care. Secondary outcomes are changes in electroencephalography (EEG) phase-locking and event-related potential components and the Coma Recovery Scale-Revised total score from prestimulation to poststimulation. Ethics and dissemination The Johns Hopkins IRB (#IRB00174966) approved this study. Trial results will be disseminated through journals and conferences. Registration number NCT03618849.",
keywords = "brain injuries, child, electroencephalography, tDCS, transcranial direct current stimulation",
author = "Saleem, {Ghazala T.} and Ewen, {Joshua Benjamin} and Crasta, {Jewel E.} and Slomine, {Beth S} and Gabriela Cantarero and Suskauer, {Stacy Jennifer M}",
year = "2019",
month = "8",
day = "1",
doi = "10.1136/bmjopen-2019-029967",
language = "English (US)",
volume = "9",
journal = "BMJ Open",
issn = "2044-6055",
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TY - JOUR

T1 - Single-arm, open-label, dose escalation phase i study to evaluate the safety and feasibility of transcranial direct current stimulation with electroencephalography biomarkers in paediatric disorders of consciousness

T2 - A study protocol

AU - Saleem, Ghazala T.

AU - Ewen, Joshua Benjamin

AU - Crasta, Jewel E.

AU - Slomine, Beth S

AU - Cantarero, Gabriela

AU - Suskauer, Stacy Jennifer M

PY - 2019/8/1

Y1 - 2019/8/1

N2 - Introduction Children with disorders of consciousness (DOC) represent the highest end of the acquired brain injury (ABI) severity spectrum for survivors and experience a multitude of functional impairments. Current clinical management in DOC uses behavioural evaluation measures and interventions that fail to (1) describe the physiological consequences of ABI and (2) elicit functional gains. In paediatric DOC, there is a critical need to develop evidence-based interventions to promote recovery of basic responses to improve rehabilitation and aid decision-making for medical teams and caregivers. The purpose of this investigation is to examine the safety, tolerability and feasibility of transcranial direct current stimulation (tDCS) in children with DOC. Methods and analysis This study is an open-label dose escalation trial evaluating the safety, tolerability and feasibility of tDCS in 10 children (5-17 years) receiving inpatient rehabilitation for DOC. This study will follow a modified rule-based design, allowing for intrapatient escalation, where a cohort of patients will be assigned to an initial tDCS current of 0.5 or 1 mA based on participant's head circumference and according to the safety data available in other paediatric populations. The subsequent assignment of increased current (1 or 2 mA) according to the prespecified rules will be based on the clinical observation of adverse events in the patients. The study will include up to three, 20 min sessions of anodal tDCS (sham, 0.5 or 1 mA, 1 or 2 mA) applied over the dorsolateral prefrontal cortex. The primary outcomes are adverse events, pain associated with tDCS and intolerable disruption of inpatient care. Secondary outcomes are changes in electroencephalography (EEG) phase-locking and event-related potential components and the Coma Recovery Scale-Revised total score from prestimulation to poststimulation. Ethics and dissemination The Johns Hopkins IRB (#IRB00174966) approved this study. Trial results will be disseminated through journals and conferences. Registration number NCT03618849.

AB - Introduction Children with disorders of consciousness (DOC) represent the highest end of the acquired brain injury (ABI) severity spectrum for survivors and experience a multitude of functional impairments. Current clinical management in DOC uses behavioural evaluation measures and interventions that fail to (1) describe the physiological consequences of ABI and (2) elicit functional gains. In paediatric DOC, there is a critical need to develop evidence-based interventions to promote recovery of basic responses to improve rehabilitation and aid decision-making for medical teams and caregivers. The purpose of this investigation is to examine the safety, tolerability and feasibility of transcranial direct current stimulation (tDCS) in children with DOC. Methods and analysis This study is an open-label dose escalation trial evaluating the safety, tolerability and feasibility of tDCS in 10 children (5-17 years) receiving inpatient rehabilitation for DOC. This study will follow a modified rule-based design, allowing for intrapatient escalation, where a cohort of patients will be assigned to an initial tDCS current of 0.5 or 1 mA based on participant's head circumference and according to the safety data available in other paediatric populations. The subsequent assignment of increased current (1 or 2 mA) according to the prespecified rules will be based on the clinical observation of adverse events in the patients. The study will include up to three, 20 min sessions of anodal tDCS (sham, 0.5 or 1 mA, 1 or 2 mA) applied over the dorsolateral prefrontal cortex. The primary outcomes are adverse events, pain associated with tDCS and intolerable disruption of inpatient care. Secondary outcomes are changes in electroencephalography (EEG) phase-locking and event-related potential components and the Coma Recovery Scale-Revised total score from prestimulation to poststimulation. Ethics and dissemination The Johns Hopkins IRB (#IRB00174966) approved this study. Trial results will be disseminated through journals and conferences. Registration number NCT03618849.

KW - brain injuries

KW - child

KW - electroencephalography

KW - tDCS

KW - transcranial direct current stimulation

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DO - 10.1136/bmjopen-2019-029967

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