tDCS in Pediatric Acquired Brain Injury
Study Details
Study Description
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). We will also explore the use of electroencephalography (EEG) as a response and predictive biomarker in pediatric ABI.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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. Additionally, we will explore whether EEG (resting-state coherence and event-related potentials) improve following tDCS and predict current behavioral function and recovery form ABI. Mozart classical music, as a concurrent intervention, will be played during sham, 1 mA, and 2 mA tDCS applications.
Study Design
Arms and Interventions
| 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 and EEG recording. |
Device: tDCS
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 and EEG recording. |
Device: tDCS
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 and EEG recording. |
Device: tDCS
Real and sham tDCS/Mozart piano sonata (K.448)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Changes in adverse events (skin problems and/or seizures) as a measure of safety [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.
- Changes in pain and discomfort as a measure of safety and tolerability [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.
- Disruption of Care Form [Up to 26 Days]
Questionnaire: Assessment of interruption of inpatient care due to child's participation in the study.
- Family Feedback Form [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.
- Number of participants with adverse events as related to tDCS [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.
Secondary Outcome Measures
- Changes in Resting-State EEG (Coherence) [Up to 26 Days]
Resting State EEG Recording: Assessment of change in the coherence components from pre-stimulation to post-stimulation
- Changes in EEG-Event-Related Potential (ERP) [Up to 26 Days]
Event-Related Potential Recording: Assessment of change in the ERP components from pre-stimulation to post-stimulation.
- Changes in Neurobehavioral functioning [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 5 through 17 years
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History of acquired brain injury.
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Currently inpatient at the Kennedy Krieger Rehabilitation Unit.
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Parent and child proficient in English.
Exclusion Criteria:
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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.
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Youth with known seizures in the month prior to study enrollment.
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Participants with non-convulsive seizures and/or interictal epileptiform discharges observed on study screening extended EEG or any of the EEG recordings during study participation.
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Females with confirmed pregnancy on urine test.
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Youth with history of craniotomy surgery, metallic cerebral, cochlear or electronic implant in the head or neck area, or ventricular shunt or pacemaker.
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Patients requiring daytime mechanical ventilation.
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Children with head circumference less than 43 cm
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Bilateral severe or profound hearing loss
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Presence of hairstyle interfering with tDCS application and/or high quality EEG signal
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Youth in foster care.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kennedy Krieger Institute | Baltimore | Maryland | United States | 21205 |
Sponsors and Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Johns Hopkins University
Investigators
- Principal Investigator: Stacy J Suskauer, MD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
- Ashwal S. Medical aspects of the minimally conscious state in children. Brain Dev. 2003 Dec;25(8):535-45. Review.
- 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. Review.
- 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.
- 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. Review.
- 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. Review.
- 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. Review.
- 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. Review.
- 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.
- IRB00174966