tDCS in Pediatric Acquired Brain Injury

NCT03618849 | Terminated

• 1 other identifier: IRB00174966
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

In this preliminary study, we will examine the safety, tolerability, and feasibility of transcranial direct current stimulation (tDCS), in the setting of dosage escalation, as a candidate intervention for children with Acquired Brain Injury (ABI).

Conditions

Acquired Brain Injury; Disorders of Consciousness

Keywords

Acquired Brain Injury; Transcranial Direct Current Stimulation; Pediatric; Safety; Feasibility

Outcome Measures

Primary Outcomes (5)

• Changes in adverse events (skin problems and/or seizures) as a measure of safety

  Adverse Event Form Questionnaire: Assessment of change from baseline and post-sham stimulation to post- stimulation (1 mA, 2 mA) and follow-up using a detailed assessment of participant's symptoms (skin problems and/or seizures) as related to transcranial direct current stimulation (tDCS) intervention.

  Baseline (1-7 days), post-stimulation (within 30-minutes), follow-up (24 hours, 48 hours, 5 days)

• Changes in pain and discomfort as a measure of safety and tolerability

  Face, Legs, Activity, Cry and Consolability Scale (FLACC) Questionnaire: Assessment of change from baseline and post-sham stimulation to pre-during-post stimulation (1 mA, 2 mA) using an observation tool that will measure pain and discomfort as related to transcranial direct current stimulation (tDCS) in children with decreased communication and cognitive impairment.

  Baseline (1-7 days), pre-during-post stimulation (pre-stimulation: within 30 minutes, during: within 20 minutes, post-stimulation: within 30-minutes)

• Disruption of Care Form

  Questionnaire: Assessment of interruption of inpatient care due to child's participation in the study.

  Up to 26 Days

• Family Feedback Form

  Questionnaire: Assessment to receive feedback about the satisfaction in the study from the parent/guardian/caregiver of the participant.

  5 days after the end of the last stimulation session.

• Number of participants with adverse events as related to tDCS

  The information on number of participants with adverse events will be collected from the beginning of sham tDCS until the end of the last tDCS session.

  Up to 26 Days

Secondary Outcomes (1)

• Changes in Neurobehavioral functioning

  Up to 4 months

Study Arms (3)

Sham tDCS

EXPERIMENTAL

Post initial screening and baseline data collection, all study participants (a single cohort of patients) will receive a single dose of sham tDCS for 20 minutes over the left dorsolateral prefrontal cortex (DLPFC) or the primary motor cortex in conjunction with Mozart piano sonata. For sham tDCS, the current will be ramped up and immediately ramped down for 30 seconds. The sham tDCS session will be preceded and followed by behavioral assessments.

Device: tDCS

1-mA tDCS

EXPERIMENTAL

Post sham-tDCS, we will determine the eligibility of the participant to receive 1 mA of real tDCS based on the occurrence of adverse events and seizures occurring within 5 days of the sham session. After a minimum of 5 days post-sham stimulation (and typically around 7 days later), the participant will receive a single dose of 1-mA current (for head circumference \>52 cm; children with head circumference 43-52cm will receive 0.5-mA) over left DLPFC or M1 in conjunction with Mozart piano sonata. The participant will receive 1-mA current for 20 minutes; the current will be ramped up for 30 seconds, will held constant at the determined intensity for 20 minutes, and then ramped down for 10 seconds. The 1-mA tDCS session will be preceded and followed by behavioral assessments.

Device: tDCS

2-mA tDCS

EXPERIMENTAL

Post 1-mA tDCS, we will again determine the eligibility of the participant to receive 2 mA current. After a minimum of 5 days post-1 mA stimulation (typically 7 days), the participant will receive a single dose of 2-mA current (if head circumference \>52cm; children with head circumference 43-52cm will receive 1-mA) over left DLPFC or M1 in conjunction with Mozart piano sonata. The participant will receive 2-mA current for 20 minutes; the current will be ramped up for 30 seconds, will held constant at the determined intensity for 20 minutes, and then ramped down for 10 seconds. The 2-mA tDCS session will be preceded and followed by behavioral assessments.

Device: tDCS

Interventions

tDCS DEVICE

Real and sham tDCS/Mozart piano sonata (K.448)

Also known as: transcranial direct current stimulation, non-invasive brain stimulation

1-mA tDCS; 2-mA tDCS; Sham tDCS

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 5 through 17 years
• History of acquired brain injury.
• Currently inpatient at the Kennedy Krieger Rehabilitation Unit.
• Parent and child proficient in English.

You may not qualify if:

• Patients with extensive focal lesions in the left dorsolateral prefrontal cortex (DLPFC) and bilateral primary motor cortex as determined by review of imaging and/or imaging reports obtained as part of clinical care.
• Youth with known seizures in the month prior to study enrollment.
• Participants with non-convulsive seizures and/or interictal epileptiform discharges observed on study screening extended EEG.
• Females with confirmed pregnancy on urine test.
• Youth with history of craniotomy surgery, metallic cerebral, cochlear or electronic implant in the head or neck area, or ventricular shunt or pacemaker.
• Patients requiring daytime mechanical ventilation.
• Children with head circumference less than 43 cm
• Bilateral severe or profound hearing loss
• Presence of hairstyle interfering with tDCS application and/or high quality EEG signal
• Youth in foster care.

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Related Publications (10)

• Thibaut A, Di Perri C, Chatelle C, Bruno MA, Bahri MA, Wannez S, Piarulli A, Bernard C, Martial C, Heine L, Hustinx R, Laureys S. Clinical Response to tDCS Depends on Residual Brain Metabolism and Grey Matter Integrity in Patients With Minimally Conscious State. Brain Stimul. 2015 Nov-Dec;8(6):1116-23. doi: 10.1016/j.brs.2015.07.024. Epub 2015 Sep 14.

  PMID: 26471400 BACKGROUND

• Krishnan C, Santos L, Peterson MD, Ehinger M. Safety of noninvasive brain stimulation in children and adolescents. Brain Stimul. 2015 Jan-Feb;8(1):76-87. doi: 10.1016/j.brs.2014.10.012. Epub 2014 Oct 28.

  PMID: 25499471 BACKGROUND

• Rivera-Urbina GN, Nitsche MA, Vicario CM, Molero-Chamizo A. Applications of transcranial direct current stimulation in children and pediatrics. Rev Neurosci. 2017 Feb 1;28(2):173-184. doi: 10.1515/revneuro-2016-0045.

  PMID: 27997354 BACKGROUND

• Gillick BT, Feyma T, Menk J, Usset M, Vaith A, Wood TJ, Worthington R, Krach LE. Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study. Phys Ther. 2015 Mar;95(3):337-49. doi: 10.2522/ptj.20130565. Epub 2014 Nov 20.

  PMID: 25413621 BACKGROUND

• Giustini A, Pistarini C, Pisoni C. Traumatic and nontraumatic brain injury. Handb Clin Neurol. 2013;110:401-9. doi: 10.1016/B978-0-444-52901-5.00034-4.

  PMID: 23312659 BACKGROUND

• Ashwal S. Medical aspects of the minimally conscious state in children. Brain Dev. 2003 Dec;25(8):535-45. doi: 10.1016/s0387-7604(03)00095-0.

  PMID: 14580666 BACKGROUND

• Giacino JT, Trott CT. Rehabilitative management of patients with disorders of consciousness: grand rounds. J Head Trauma Rehabil. 2004 May-Jun;19(3):254-65. doi: 10.1097/00001199-200405000-00006.

  PMID: 15247847 BACKGROUND

• Ragazzoni A, Cincotta M, Giovannelli F, Cruse D, Young GB, Miniussi C, Rossi S. Clinical neurophysiology of prolonged disorders of consciousness: From diagnostic stimulation to therapeutic neuromodulation. Clin Neurophysiol. 2017 Sep;128(9):1629-1646. doi: 10.1016/j.clinph.2017.06.037. Epub 2017 Jun 29.

  PMID: 28728060 BACKGROUND

• Chung MG, Lo WD. Noninvasive brain stimulation: the potential for use in the rehabilitation of pediatric acquired brain injury. Arch Phys Med Rehabil. 2015 Apr;96(4 Suppl):S129-37. doi: 10.1016/j.apmr.2014.10.013. Epub 2014 Nov 6.

  PMID: 25448248 BACKGROUND

• Saleem GT, Ewen JB, Crasta JE, Slomine BS, Cantarero GL, Suskauer SJ. 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. BMJ Open. 2019 Aug 10;9(8):e029967. doi: 10.1136/bmjopen-2019-029967.

  PMID: 31401607 DERIVED

MeSH Terms

Conditions

Brain Injuries; Consciousness Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Stacy J Suskauer, MD

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Dosage-escalation study

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: August 7, 2018
• Study Start: August 1, 2019
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)