- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03618849
tDCS in Pediatric Acquired Brain Injury
Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Acquired Brain Injury (tDCS in Pediatric ABI)
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stacy J Suskauer, MD
- Phone Number: 443-923-9440
- Email: suskauer@kenndykrieger.org
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Kennedy Krieger Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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Real and sham tDCS/Mozart piano sonata (K.448)
Other Names:
|
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.
|
Real and sham tDCS/Mozart piano sonata (K.448)
Other Names:
|
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.
|
Real and sham tDCS/Mozart piano sonata (K.448)
Other Names:
|
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)
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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.
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Baseline (1-7 days), post-stimulation (within 30-minutes), follow-up (24 hours, 48 hours, 5 days)
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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)
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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.
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Baseline (1-7 days), pre-during-post stimulation (pre-stimulation: within 30 minutes, during: within 20 minutes, post-stimulation: within 30-minutes)
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Disruption of Care Form
Time Frame: Up to 26 Days
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Questionnaire: Assessment of interruption of inpatient care due to child's participation in the study.
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Up to 26 Days
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Family Feedback Form
Time Frame: 5 days after the end of the last stimulation session.
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Questionnaire: Assessment to receive feedback about the satisfaction in the study from the parent/guardian/caregiver of the participant.
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5 days after the end of the last stimulation session.
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Number of participants with adverse events as related to tDCS
Time Frame: Up to 26 Days
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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.
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Up to 26 Days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Neurobehavioral functioning
Time Frame: Up to 4 months
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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).
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Up to 4 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stacy J Suskauer, MD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00174966
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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