tDCS in Pediatric Acquired Brain Injury

January 31, 2024 updated by: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Acquired Brain Injury (tDCS in Pediatric ABI)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Previous studies have demonstrated that transcranial direct current stimulation (tDCS) is safe and effective in adults with chronic Acquired Brain Injury. Limited data have established the safety of tDCS in children with neuropsychiatric and neuromotor disorders. However, these tDCS safety paradigms may not be relevant to children with ABI due to their abnormal brain structure and function, decreased ability to communicate, variable symptomology, and time-consuming care needs that exist in this population.

In this open-label, single-group, dosage escalation study, investigators aim to assess the safety, tolerability, and feasibility of incrementally higher tDCS currents in 10 pediatric patients with ABI on an inpatient rehabilitation unit. The study will include up to three sessions of tDCS (sham, 1mA, and then 2 mA) either over the left dorsolateral prefrontal cortex or over the primary motor cortex based on the goal to evaluate change in either cognitive or motor function. We will also explore whether tDCS improves consciousness in pediatric DOC. Mozart classical music, as a concurrent intervention, will be played during sham, 1 mA, and 2 mA tDCS applications.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Kennedy Krieger Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sham tDCS
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
Real and sham tDCS/Mozart piano sonata (K.448)
Other Names:
  • transcranial direct current stimulation
  • non-invasive brain stimulation
Experimental: 1-mA tDCS
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
Real and sham tDCS/Mozart piano sonata (K.448)
Other Names:
  • transcranial direct current stimulation
  • non-invasive brain stimulation
Experimental: 2-mA tDCS
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
Real and sham tDCS/Mozart piano sonata (K.448)
Other Names:
  • transcranial direct current stimulation
  • non-invasive brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in adverse events (skin problems and/or seizures) as a measure of safety
Time Frame: Baseline (1-7 days), post-stimulation (within 30-minutes), follow-up (24 hours, 48 hours, 5 days)
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
Time Frame: Baseline (1-7 days), pre-during-post stimulation (pre-stimulation: within 30 minutes, during: within 20 minutes, post-stimulation: within 30-minutes)
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
Time Frame: Up to 26 Days
Questionnaire: Assessment of interruption of inpatient care due to child's participation in the study.
Up to 26 Days
Family Feedback Form
Time Frame: 5 days after the end of the last stimulation session.
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
Time Frame: Up to 26 Days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Neurobehavioral functioning
Time Frame: Up to 4 months
Modified Functional Reach Task, Grooved Pegboard, Digit Span, or Coma-Recovery Scale Revised: Task chosen based on child's functional status and assessment of change from baseline, post-sham stimulation, and pre-stimulations (1 mA, 2 mA).
Up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Johns Hopkins University

Investigators

  • Principal Investigator: Stacy J Suskauer, MD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

June 13, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00174966

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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