Study Summary
This trial will explore whether transcranial direct current stimulation is a safe and tolerable intervention for children with acquired brain injury, as well as whether EEG can predict response to the intervention.
Eligible Conditions
- Acquired Brain Injury
- Disorders of Consciousness
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
5 Primary · 3 Secondary · Reporting Duration: Up to 4 months
Day 5
Family Feedback Form
Day 7
Changes in adverse events (skin problems and/or seizures) as a measure of safety
Day 7
Changes in pain and discomfort as a measure of safety and tolerability
Up to 26 Days
Changes in EEG-Event-Related Potential (ERP)
Changes in Resting-State EEG (Coherence)
Disruption of Care Form
Number of participants with adverse events as related to tDCS
Up to 4 months
Changes in Neurobehavioral functioning
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
3 Treatment Groups
2-mA tDCS
1 of 3
1-mA tDCS
1 of 3
Sham tDCS
1 of 3
Experimental Treatment
10 Total Participants · 3 Treatment Groups
Primary Treatment: tDCS · No Placebo Group · N/A
2-mA tDCS
Device
Experimental Group · 1 Intervention: tDCS · Intervention Types: Device1-mA tDCS
Device
Experimental Group · 1 Intervention: tDCS · Intervention Types: DeviceSham tDCS
Device
Experimental Group · 1 Intervention: tDCS · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tDCS
2017
Completed Phase 2
~760
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 months
Who is running the clinical trial?
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
83 Previous Clinical Trials
24,498 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,115 Previous Clinical Trials
32,578,759 Total Patients Enrolled
Stacy J Suskauer, MDPrincipal InvestigatorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eligibility Criteria
Age 5 - 17 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have had a brain injury in the past.
References
- Ragazzoni, Aldo, Massimo Cincotta, Fabio Giovannelli, Damian Cruse, G. Bryan Young, Carlo Miniussi, and Simone Rossi. 2017. “Clinical Neurophysiology of Prolonged Disorders of Consciousness: From Diagnostic Stimulation to Therapeutic Neuromodulation”. Clinical Neurophysiology. Elsevier BV. doi:10.1016/j.clinph.2017.06.037.
- Chung, Melissa G., and Warren D. Lo. 2015. “Noninvasive Brain Stimulation: The Potential for Use in the Rehabilitation of Pediatric Acquired Brain Injury”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2014.10.013.
- Krishnan, Chandramouli, Luciana Santos, Mark D. Peterson, and Margaret Ehinger. 2015. “Safety of Noninvasive Brain Stimulation in Children and Adolescents”. Brain Stimulation. Elsevier BV. doi:10.1016/j.brs.2014.10.012.
- Giustini, Alessandro, Caterina Pistarini, and Camilla Pisoni. 2013. “Traumatic and Nontraumatic Brain Injury”. Neurological Rehabilitation. Elsevier. doi:10.1016/b978-0-444-52901-5.00034-4.
- Rivera-Urbina, Guadalupe Nathzidy, Michael A. Nitsche, Carmelo M. Vicario, and Andrés Molero-Chamizo. 2017. “Applications of Transcranial Direct Current Stimulation in Children and Pediatrics”. Reviews in the Neurosciences. Walter de Gruyter GmbH. doi:10.1515/revneuro-2016-0045.
- Thibaut, Aurore, Carol Di Perri, Camille Chatelle, Marie-Aurélie Bruno, Mohamed Ali Bahri, Sarah Wannez, Andrea Piarulli, et al.. 2015. “Clinical Response to Tdcs Depends on Residual Brain Metabolism and Grey Matter Integrity in Patients with Minimally Conscious State”. Brain Stimulation. Elsevier BV. doi:10.1016/j.brs.2015.07.024.
- Ashwal, Stephen. 2003. “Medical Aspects of the Minimally Conscious State in Children”. Brain and Development. Elsevier BV. doi:10.1016/s0387-7604(03)00095-0.
- Saleem, Ghazala T, Joshua Benjamin Ewen, Jewel E Crasta, Beth S Slomine, Gabriela Lucila Cantarero, and Stacy J Suskauer. 2019. “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. BMJ. doi:10.1136/bmjopen-2019-029967.
- Gillick, Bernadette T., Tim Feyma, Jeremiah Menk, Michelle Usset, Amy Vaith, Teddi Jean Wood, Rebecca Worthington, and Linda E. Krach. 2015. “Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Hemiparesis: Randomized Controlled Preliminary Study”. Physical Therapy. Oxford University Press (OUP). doi:10.2522/ptj.20130565.
- Giacino, Joseph T., and Charlotte T. Trott. 2004. “Rehabilitative Management of Patients with Disorders of Consciousness”. Journal of Head Trauma Rehabilitation. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00001199-200405000-00006.
- Krishnan, Chandramouli, Luciana Santos, Mark D. Peterson, and Margaret Ehinger. 2015. “Safety of Noninvasive Brain Stimulation in Children and Adolescents”. Brain Stimulation. Elsevier BV. doi:10.1016/j.brs.2014.10.012.
- Gillick, Bernadette T., Tim Feyma, Jeremiah Menk, Michelle Usset, Amy Vaith, Teddi Jean Wood, Rebecca Worthington, and Linda E. Krach. 2015. “Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Hemiparesis: Randomized Controlled Preliminary Study”. Physical Therapy. Oxford University Press (OUP). doi:10.2522/ptj.20130565.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2019. "tDCS in Pediatric Acquired Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03618849.
Frequently Asked Questions
Are researchers currently seeking out participants for this experiment?
"Affirmative. According to the records on clinicaltrials.gov, this experiment is accepting participants as of now. It was initially posted November 13th 2019 and has been updated most recently on March 14th 2022. The researchers require 10 individuals from a single site for participation in the trial.." - Anonymous Online Contributor
Unverified Answer
Is this study open to individuals aged 20 and above?
"In accordance with the specified eligibility requirements, participants must be between 5 and 17 years of age." - Anonymous Online Contributor
Unverified Answer
How many people are actively participating in this medical experiment?
"Correct. According to clinicaltrials.gov, this medical experiment is still recruiting participants since its initial posting date of November 13th 2019 and last update on March 14th 2022; the study calls for 10 individuals from one site." - Anonymous Online Contributor
Unverified Answer
What are the qualifying criteria for participation in this research endeavor?
"This research study requires a maximum of 10 participants to have been diagnosed with some degree of consciousness disorder, and they must fall within the age bracket 5-17 years old." - Anonymous Online Contributor
Unverified Answer