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Procedure

Brain Stimulation + Cognitive Training for Mild Traumatic Brain Injury

N/A

Recruiting

Led By Lars D Hungerford, PhD

Research Sponsored by United States Naval Medical Center, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18 to 60

At least one cognitive symptom reported on the Neurobehavioral Symptom Inventory (NSI) cognitive subscale

Must not have

Newly prescribed medication within the previous 3 weeks

Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation may pose a significant risk to the participant, raises the possibility that the participant is unlikely to successfully complete all of the requirements of the study according to the study protocol, or 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected during the intervention block at sessions 1, 5, & 10 (b/t baseline & 1-week post)

Summary

This trial will test a new way to help improve attention in military personnel and veterans who have experienced mild traumatic brain injuries. The method involves using a brain stimulation technique called "Remotely Supervised Trans

Who is the study for?

This trial is for Active Duty Service Members and Veterans who have experienced mild Traumatic Brain Injury (mTBI) and are struggling with complex attention issues. Participants should be interested in a home-based cognitive rehabilitation program using brain stimulation and cognitive training.

What is being tested?

The study tests 'Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training' (RS-tDCS+), comparing active brain stimulation to sham (placebo). It aims to improve attention by enhancing learning and the brain's adaptability, measured through various tests over time.

What are the potential side effects?

RS-tDCS+ is low-risk and non-invasive, but side effects may include discomfort at the electrode site, itching or tingling during stimulation, fatigue, headache, or nausea. These are typically mild.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I have reported cognitive symptoms like memory loss or difficulty concentrating.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I started a new medication less than 3 weeks ago.

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I do not have any health conditions that could risk my safety or affect the study's results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected during the intervention block at sessions 1, 5, & 10 (b/t baseline & 1-week post)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected during the intervention block at sessions 1, 5, & 10 (b/t baseline & 1-week post)

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected during the intervention block at sessions 1, 5, & 10 (b/t baseline & 1-week post) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ecological Momentary Assessment (EMA)

Electroencephalogram (EEG) - Resting State Functional Connectivity

Electroencephalogram (EEG) - Resting State Spectral Power

+19 more

Secondary study objectives

BrainHQ Task Load Index (TLX)

Fusion Task Load Index (F-TLX)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCSExperimental Treatment1 Intervention

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.

Group II: Sham tDCSPlacebo Group1 Intervention

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

0 / 4Eligibility criteria met