Active tDCS + Cognitive Training for Mild TBI in Active Duty Service Members

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from 1 week post-intervention isi at 6 weeks after the intervention.

Summary

This trial will test if a new brain stimulation technique, transcranial direct current stimulation (tDCS), can help improve attention and working memory in military service members with a history of mild traumatic brain injury (TBI).

Who is the study for?

Active Duty Service Members aged 18-55 with a history of mild TBI at least 6 months prior and moderate neurocognitive symptoms. Participants must be stable on medications for two weeks before starting the trial. Exclusions include a history of seizures, recent neuromodulation studies, intellectual disability, significant neurological disorders other than mild TBI, current stimulant dependence or active psychosis/manic episodes.

What is being tested?

The study tests whether brain stimulation (tDCS) combined with cognitive training can improve attention and memory in those with mild TBI. It compares the effects of actual tDCS versus sham (fake) treatment alongside cognitive exercises to assess improvements in brain function and self-reported outcomes.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site on the scalp, headache, fatigue, nausea or itching under electrode placement during tDCS sessions. There is also a low risk of inducing seizures for individuals predisposed to them.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after the intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after the intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the intervention. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Electroencephalogram (EEG)

Magnetic Resonance Imaging (MRI) w/out contrast (optional)

Neurobehavioral Symptom Inventory (NSI)

+2 more

Secondary study objectives

BrainHQ Task Load Index (TLX)

Fusion Task

Insomnia Severity Index (ISI)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCSExperimental Treatment1 Intervention

Based on previous studies targeting working memory, focality of current delivery, and comfort and tolerance levels, (Paulo S. Boggio et al., 2006; Hill et al., 2016; Hoy et al., 2013; Teo, Hoy, Daskalakis, \& Fitzgerald, 2011), we will use a 2 mA current administered via two circular carbon rubber core electrodes in saline-soaked surface sponges (25 cm2), placed in a neoprene headcap with marked locations based on the 10-10 EEG system. The anodal stimulating electrode will be at location F3, over left dorsolateral prefrontal cortex (DLPFC) and the cathodal electrode at location F4, over right DLPFC. Two reference electrodes, CMS and DRL, will be attached to the EarClip and applied to the earlobe with conductive gel. Before each training session, the impedance of the electrodes will be checked and verified to be ≤15 KOhm. Additionally, the stimulation will be terminated if the impedance of the electrodes is \> 20 KOhm. The current and impedance will be recorded for every session.

Group II: Sham tDCSPlacebo Group1 Intervention

For sham stimulation, the electrodes will be placed at the same positions as for active stimulation (F3 and F4). After an initial ramp-up period of 30 seconds, stimulation fades out over a period of 30 seconds. Additionally, at the end of the sham stimulation period, stimulation will fade in over a period of 30 seconds and then end with a final 30 second ramp-down period. Participants will feel the initial itching sensation associated with tDCS and experience the ramp-down period at the end of the sham stimulation period but will receive no active current during the rest of the sham stimulation period. This method of sham stimulation has been shown to be reliable (Gandiga et al., 2006). Before each training session, the impedance of the electrodes will be checked and verified to be ≤15 KOhm. Additionally, the stimulation will be terminated if the impedance of the electrodes is \> 20 KOhm. The current and impedance will be recorded for every session.

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