tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study
Brain Concussion, Brain Trauma, Attention Concentration Difficulty
About this trial
This is an interventional treatment trial for Brain Concussion focused on measuring military health, brain stimulation, cognitive training, cognitive rehabilitation
Eligibility Criteria
Inclusion Criteria:
- (1) Have a remote history mild traumatic brain injury as defined by the VA/DoD clinical practice guidelines(The Management of Concussion/mTBI Working Group, 2016) that is >/= 6 months, and report moderate severity neurocognitive symptoms related to attention, concentration, working memory, or memory based on NSI scores and self-report.
- (2) Are between the ages of 18-55.
- (3) Are stable on any medications for at least 2 weeks at the baseline visit (Visit #1).
Exclusion Criteria:
- (1) Have a history of seizures or epilepsy.
- (2) Have a history of ECT or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies.
- (3) Have current stimulant dependence.
- (4) Have a diagnosis of intellectual disability or pervasive developmental disorder (i.e. premorbid IQ less than or equal to 70).
- (5) Have 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 judgement, would impact risk.
- (6) Diagnosed with current active psychosis or mania.
- (7) Have metallic cranial plates/screws or implanted device,
- (8) Have eczema on scalp or other scalp lesions or skin disorders that may become irritated by stimulation.
- (9) Pregnant individuals and individuals with ferromagnetic metal in their body that would prohibit them from being safe in the MRI will not be excluded from the overall study, but will be excluded from the optional MRI.
Sites / Locations
- Naval Medical Center San DiegoRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active tDCS
Sham tDCS
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.
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.