tDCS in Pediatric Acquired Brain Injury

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03618849
• Other study ID #: IRB00174966
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2024
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Consciousness Disorders
• Disorders of Consciousness
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Disruption of Care Form	Questionnaire: Assessment of interruption of inpatient care due to child's participation in the study.	Up to 26 Days
Primary	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.
Primary	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	Changes in Neurobehavioral functioning	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