Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)
NCT ID: NCT06413173
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2024-07-25
2028-09-30
Brief Summary
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Detailed Description
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Attention, concentration, and working memory (i.e., complex attention) deficits are the most reported neurocognitive sequelae of mild traumatic brain injury (mTBI) and have been associated with patterns of decreased neural activation. Existing cognitive rehabilitation interventions require significant time and effort and are limited by small-to-moderate effect sizes and uncertain durability/generalization of effects. Novel, neuroplasticity-based interventions that improve complex attention and can be administered remotely are needed to increase access to care, decrease recovery time, and improve outcomes and quality of life following mTBI. This multi-site study will investigate remotely-supervised tDCS (RS-tDCS) combined with cognitive training in the chronic phase of recovery (≥3 months) from mTBI to 1) increase accessibility to care, 2) improve cognitive functioning, post-concussion symptom outcomes, and quality of life and 3) investigate the durability of the intervention in Active Duty Service Members (ADSM; at the Naval Medical Center San Diego (NMCSD) and Veterans (at the Minneapolis VA Health care System (MVAHCS)).
Research Plan and Methods:
This is a double-blind, randomized, sham-controlled study. 80 Veterans from the MVAHCS and 80 ADSM from NMCSD (total N=160) will be recruited. Participants will have a history of mTBI and self-reported attention and/or concentration difficulties. Baseline assessment will include self-reported symptoms and objective neurocognitive performance. Resting state functional connectivity changes will be measured with functional magnetic resonance imaging (fMRI) and oscillatory brain activity will be measured with EEG, both collected at baseline and at post-intervention assessments. Participants will be randomized to either active RS-tDCS or sham RS-tDCS, using stratified randomization by baseline cognitive scores. The intervention sessions will occur in the participant's home, 10 sessions within 2 weeks. Two post-intervention assessments, mirroring the baseline assessment, will occur approximately 1 week and 6 weeks after the intervention. Additionally, the investigators will collect longitudinal real-time data, daily, on TBI symptoms, cognitive, and mood factors during the 6 weeks post-intervention using Ecological Momentary Assessment (EMA).
Clinical Relevance:
RS-tDCS+ addresses two major obstacles of current TBI treatments: Accessibility and adherence. RS-tDCS+ offers several benefits as it can be monitored remotely, and can be self-administered in the home after the first session. If RS-tDCS proves effective, this non-invasive intervention could dramatically improve access to a validated treatment that can be rapidly implemented within various DOD and VA settings to reduce TBI-related symptoms, improve cognition, enhance recovery, bolster occupational performance, and improve quality of life.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active tDCS
Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation. Stimulation will be applied for 20 minutes at the beginning of each session. Current will be ramped from 0 mA to 2 mA over 30 seconds, and then ramped down from 2 mA to 0 mA at the end of 20 minutes. Current will be applied via two electrodes consisting of a pre-inserted carbon rubber snap electrode that is pre-saturated with saline and connects directly to designated electrode sites located on the tDCS headband. The anodal stimulating electrode will be at location F3 (based on the 10-20 EEG location system) and the cathodal electrode at location F4.
Active tDCS and Cognitive Training Intervention
Cognitive training will occur concurrently with active tDCS session. The cognitive training occurs on a computer and consists of 5 exercises specifically selected and scientifically supported to (i) place demands on the executive function system (e.g. working memory, behavioral inhibition, decision making, and set- shifting), (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across visual and auditory modalities During each 45-minute training period, participants will complete the daily assigned adaptive training module. Following the completion of training sessions 1, 5, and 10, participants will be asked to supply a subjective workload assessment.
Sham tDCS
Electrodes will be placed at the same positions as for active stimulation (F3 and F4), but current will be ramped down immediately after the initial 30s ramp up period and then at 20 minutes ramped up and down as done at the beginning. Thus, participants feel the initial tingling sensation associated with tDCS, but will receive no active current for the rest of the stimulation period
Sham tDCS and Cognitive Training Intervention
Cognitive training will occur concurrently with sham tDCS session. The cognitive training occurs on a computer and consists of 5 exercises specifically selected and scientifically supported to (i) place demands on the executive function system (e.g. working memory, behavioral inhibition, decision making, and set- shifting), (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across visual and auditory modalities During each 45-minute training period, participants will complete the daily assigned adaptive training module. Following the completion of training sessions 1, 5, and 10, participants will be asked to supply a subjective workload assessment.
Interventions
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Active tDCS and Cognitive Training Intervention
Cognitive training will occur concurrently with active tDCS session. The cognitive training occurs on a computer and consists of 5 exercises specifically selected and scientifically supported to (i) place demands on the executive function system (e.g. working memory, behavioral inhibition, decision making, and set- shifting), (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across visual and auditory modalities During each 45-minute training period, participants will complete the daily assigned adaptive training module. Following the completion of training sessions 1, 5, and 10, participants will be asked to supply a subjective workload assessment.
Sham tDCS and Cognitive Training Intervention
Cognitive training will occur concurrently with sham tDCS session. The cognitive training occurs on a computer and consists of 5 exercises specifically selected and scientifically supported to (i) place demands on the executive function system (e.g. working memory, behavioral inhibition, decision making, and set- shifting), (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across visual and auditory modalities During each 45-minute training period, participants will complete the daily assigned adaptive training module. Following the completion of training sessions 1, 5, and 10, participants will be asked to supply a subjective workload assessment.
Eligibility Criteria
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Inclusion Criteria
2. Ages 18 to 60.
3. All genders.
4. All racial and ethnic groups.
5. History of mild TBI (as defined by the DOD/VA criteria used in conjunction with the OSU TBI-ID) sustained at least 3 months and no more than 10 years prior to enrollment.
6. Self-reported attention and/or concentration difficulties.
7. At least one cognitive symptom reported on the Neurobehavioral Symptom Inventory (NSI) cognitive subscale.
Exclusion Criteria
2. History of prior treatment with ECT or neuromodulation in the last 12 months.
3. Current, diagnosed substance dependence.
4. Newly prescribed medication within the previous 3 weeks.
5. Diagnosis of intellectual disability or pervasive developmental disorder (i.e., premorbid IQ less than or equal to 70).
6. Any medical condition or treatment other than mild TBI (e.g., stroke, tumor, HIV, moderate-severe TBI), with significant neurological disorder or insults that, based on the Principal Investigator's judgment, would impact risk.
7. Psychosis or mania within 30 days of enrollment, as determined by the PI, based on a psychiatric history and examination and/or a review of available medical records
8. Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp)
9. A positive pregnancy report.
18 Years
60 Years
ALL
No
Sponsors
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Minneapolis Veterans Affairs Medical Center
FED
University of Minnesota
OTHER
United States Department of Defense
FED
Center for Veterans Research and Education
OTHER
The Defense and Veterans Brain Injury Center
FED
General Dynamics Information Technology
UNKNOWN
United States Naval Medical Center, San Diego
FED
Responsible Party
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Lars Hungerford
Senior Clinical Research Director
Principal Investigators
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Lars D Hungerford, PhD
Role: PRINCIPAL_INVESTIGATOR
United States Naval Medical Center, San Diego
Locations
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Naval Medical Center San Diego
San Diego, California, United States
Minneapolis VA Health Case System
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Lars D Hungerford, Ph.D
Role: primary
Sean M Molnar, M.A.
Role: backup
Casey Gilmore, Ph.D
Role: primary
Florence Larkin, B.S.
Role: backup
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NMCSD.2023.0048
Identifier Type: -
Identifier Source: org_study_id