Clinical trial NCT06413173: Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)
Official title: Remotely Supervised tDCS Combined With Cognitive Training to Improve Complex Attention in Active Duty Service Members and Veterans With Mild TBI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Concussion
Brain Trauma
Attention Concentration Difficulty
Brain Injuries
Brain Injuries, Traumatic
Neurocognitive Dysfunction
Attention Impaired
Memory Impairment
Mild Traumatic Brain Injury
Mild Cognitive Impairment
Post Concussive Symptoms
Keywords: Military Health
Brain Stimulation
Cognitive Training
Cognitive Rehabilitation
Telehealth
Neuromodulation
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: Minneapolis Veterans Affairs Medical Center
name: University of Minnesota
name: United States Department of Defense
name: Center for Veterans Research and Education
name: The Defense and Veterans Brain Injury Center
name: General Dynamics Information Technology
First posted: 2024-05-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double-blind, randomized, placebo (sham) controlled pilot study.
Primary purpose: TREATMENT

Brief summary: The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.

Detailed description: Objectives:

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.

Eligibility criteria: Inclusion Criteria:

1. Active-Duty Service Members.
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:

1. Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation, in the opinion of the PI: (a) may pose a significant risk to the participant; (b) raises the possibility that the participant is unlikely to successfully complete all of the requirements of the study according to the study protocol; or (c) might adversely impact the integrity of the data or the validity of the study results. Specific conditions include (but are not limited to) a history of: brain tumor, epilepsy, cerebral vascular accident (CVA), Schizophrenia, Bipolar Disorder, and Mania.
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.

Primary outcomes:
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
measure: Neuropsychological Assessment Battery (NAB) Attention Module
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
measure: Neurobehavioral Symptom Inventory (NSI)
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
measure: Electroencephalogram (EEG) - Resting State Functional Connectivity
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
measure: Electroencephalogram (EEG) - Resting State Spectral Power
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
measure: Magnetic Resonance Imaging (MRI) - T1 (optional)
timeFrame: Baseline & 1-week post intervention
measure: Magnetic Resonance Imaging (MRI) - T2 (optional)
timeFrame: Baseline & 1-week post intervention
measure: Magnetic Resonance Imaging (MRI) - T2* (optional)
timeFrame: Baseline & 1-week post intervention
measure: Magnetic Resonance Imaging (MRI) - DWI (optional)
timeFrame: Baseline & 1-week post intervention
measure: Magnetic Resonance Imaging (MRI) - ASL (optional)
timeFrame: Baseline & 1-week post intervention
measure: Magnetic Resonance Imaging (MRI) - ROI Analysis (optional)
timeFrame: Baseline & 1-week post intervention
measure: NIH Toolbox Quality of Life Assessment (NeuroQoL)
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
measure: PTSD Checklist- Civilian Version (PCL-C)
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
measure: Patient Global Impression of Change (PGIC)
timeFrame: 1-week post & 6-weeks post intervention
measure: Information Sampling Task (IST)
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
measure: Groton Maze Learning Task (GMLT)
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
measure: Fusion Task: BEAM
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
measure: Fusion Task: N-Back
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
measure: tDCS Symptom Rating Questionnaire (SRQ)
timeFrame: Assessment collected daily during the intervention block (b/t baseline & 1-week post)
measure: Ecological Momentary Assessment (EMA)
timeFrame: Assessment collected daily during the intervention block (b/t baseline & 1-week post)
Secondary outcomes:
measure: BrainHQ Task Load Index (TLX)
timeFrame: Collected during the Intervention block at sessions 1, 5, & 10 (b/t baseline & 1-week post)
measure: Fusion Task Load Index (F-TLX)
timeFrame: Baseline, 1-week post, & 6-weeks post intervention
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Minneapolis
country: United States
facility: Minneapolis VA Health Case System
state: Minnesota
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Lars D Hungerford, PhD
role: PRINCIPAL_INVESTIGATOR
References: