Back to resultstDCS in Pediatric Acquired Brain Injury
Primary Purpose
Acquired Brain Injury, Disorders of Consciousness
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Brain Injury focused on measuring Acquired Brain Injury, Transcranial Direct Current Stimulation, Pediatric, Safety, Feasibility
Eligibility Criteria
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 or any of the EEG recordings during study participation.
- 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.
Sites / Locations
- Kennedy Krieger InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Sham tDCS
1-mA tDCS
2-mA tDCS
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Disruption of Care Form
Questionnaire: Assessment of interruption of inpatient care due to child's participation in the study.
Family Feedback Form
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
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 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).
Full Information
NCT ID
NCT03618849
First Posted
June 13, 2018
Last Updated
March 20, 2023
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03618849
Brief Title
tDCS in Pediatric Acquired Brain Injury
Official Title
Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Acquired Brain Injury (tDCS in Pediatric ABI)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury, Disorders of Consciousness
Keywords
Acquired Brain Injury, Transcranial Direct Current Stimulation, Pediatric, Safety, Feasibility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Dosage-escalation study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
1-mA tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
2-mA tDCS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
transcranial direct current stimulation, non-invasive brain stimulation
Intervention Description
Real and sham tDCS/Mozart piano sonata (K.448)
Primary Outcome Measure Information:
Title
Changes in adverse events (skin problems and/or seizures) as a measure of safety
Description
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.
Time Frame
Baseline (1-7 days), post-stimulation (within 30-minutes), follow-up (24 hours, 48 hours, 5 days)
Title
Changes in pain and discomfort as a measure of safety and tolerability
Description
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.
Time Frame
Baseline (1-7 days), pre-during-post stimulation (pre-stimulation: within 30 minutes, during: within 20 minutes, post-stimulation: within 30-minutes)
Title
Disruption of Care Form
Description
Questionnaire: Assessment of interruption of inpatient care due to child's participation in the study.
Time Frame
Up to 26 Days
Title
Family Feedback Form
Description
Questionnaire: Assessment to receive feedback about the satisfaction in the study from the parent/guardian/caregiver of the participant.
Time Frame
5 days after the end of the last stimulation session.
Title
Number of participants with adverse events as related to tDCS
Description
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.
Time Frame
Up to 26 Days
Secondary Outcome Measure Information:
Title
Changes in Neurobehavioral functioning
Description
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).
Time Frame
Up to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacy J Suskauer, MD
Phone
443-923-9440
Email
suskauer@kenndykrieger.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy J Suskauer, MD
Organizational Affiliation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy J Suskauer, MD
Email
Suskauer@kennedykrieger.org
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26471400
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.
Results Reference
background
PubMed Identifier
25499471
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.
Results Reference
background
PubMed Identifier
27997354
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.
Results Reference
background
PubMed Identifier
25413621
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.
Results Reference
background
PubMed Identifier
23312659
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.
Results Reference
background
PubMed Identifier
14580666
Citation
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.
Results Reference
background
PubMed Identifier
15247847
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.
Results Reference
background
PubMed Identifier
28728060
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.
Results Reference
background
PubMed Identifier
25448248
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.
Results Reference
background
PubMed Identifier
31401607
Citation
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.
Results Reference
derived
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tDCS in Pediatric Acquired Brain Injury
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