Active tDCS + Cognitive Training for Mild TBI in Active Duty Service Members
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: United States Naval Medical Center, San Diego
Must not be taking: Stimulants
Disqualifiers: Seizures, Epilepsy, Psychosis, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The proposed study will evaluate a new approach to cognitive rehabilitation of mild traumatic brain injury (mTBI) using a brain stimulation technique called transcranial direct current stimulation (tDCS). Specifically, we will investigate how tDCS combined with cognitive training improves deficits to attention and working memory in Active Duty Service Members with a history of mild traumatic brain injury (TBI). Measures of attention-related brain activity, neurocognitive assessments, and self-reported clinical outcomes will be used to determine effects of tDCS vs. sham tDCS when paired with a cognitive training intervention. By doing this study, we hope to find a reliable, noninvasive, and efficient method of treating mild TBI cognitive symptoms.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be stable on any medications for at least 2 weeks before starting the trial.
What data supports the effectiveness of this treatment for mild TBI in active duty service members?
Research shows that transcranial direct current stimulation (tDCS) combined with cognitive training can improve cognitive functions like working memory and attention in people with traumatic brain injuries. Studies found that participants receiving this treatment had better reaction times and fewer attention-related errors compared to those who did not receive the active treatment.12345
Is transcranial direct current stimulation (tDCS) safe for humans?
How does the treatment of active tDCS combined with cognitive training for mild TBI differ from other treatments?
This treatment is unique because it combines transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, with cognitive training to improve cognitive function in individuals with mild traumatic brain injury (TBI). Unlike other treatments, this approach aims to enhance brain plasticity and cognitive recovery by directly stimulating specific brain areas while simultaneously engaging patients in cognitive tasks.1241011
Eligibility Criteria
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.Inclusion Criteria
You had a mild traumatic brain injury at least 6 months ago and still have problems with attention, memory, or thinking according to a specific test and your own report.
Are stable on any medications for at least 2 weeks at the baseline visit (Visit #1)
You had a mild brain injury more than 6 months ago and still have trouble with memory or paying attention.
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Exclusion Criteria
You have had seizures or epilepsy in the past.
You had electroconvulsive therapy (ECT) or other brain stimulation treatments in the past year, or took part in similar research studies.
You have been diagnosed with a condition that affects how you learn and understand things, or how you develop.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive transcranial direct current stimulation (tDCS) combined with cognitive training over five consecutive days
1 week
5 visits (in-person)
Post-intervention Assessment
Participants undergo post-intervention assessment of symptoms, neurocognitive performance, and optional MRI scan
1 week
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of symptoms and neurocognitive performance
6 weeks
1 visit (in-person)
Treatment Details
Interventions
- Cognitive Training Intervention (Behavioural Intervention)
- tDCS (Procedure)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Naval Medical Center San DiegoSan Diego, CA
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Who Is Running the Clinical Trial?
United States Naval Medical Center, San DiegoLead Sponsor
The Defense and Veterans Brain Injury CenterCollaborator
References
Concomitant Use of Transcranial Direct Current Stimulation and Computer-Assisted Training for the Rehabilitation of Attention in Traumatic Brain Injured Patients: Behavioral and Neuroimaging Results. [2022]Divided attention (DA), the ability to distribute cognitive resources among two or more simultaneous tasks, may be severely compromised after traumatic brain injury (TBI), resulting in problems with numerous activities involved with daily living. So far, no research has investigated whether the use of non-invasive brain stimulation associated with neuropsychological rehabilitation might contribute to the recovery of such cognitive function. The main purpose of this study was to assess the effectiveness of 10 transcranial direct current stimulation (tDCS) sessions combined with computer-assisted training; it also intended to explore the neural modifications induced by the treatment. Thirty-two patients with severe TBI participated in the study: 16 were part of the experimental group, and 16 part of the control group. The treatment included 20' of tDCS, administered twice a day for 5 days. The electrodes were placed on the dorso-lateral prefrontal cortex. Their location varied across patients and it depended on each participant's specific area of damage. The control group received sham tDCS. After each tDCS session, the patient received computer-assisted cognitive training on DA for 40'. The results showed that the experimental group significantly improved in DA performance between pre- and post-treatment, showing faster reaction times (RTs), and fewer omissions. No improvement was detected between the baseline assessment (i.e., 1 month before treatment) and the pre-training assessment, or within the control group. Functional magnetic resonance imaging (fMRI) data, obtained on the experimental group during a DA task, showed post-treatment lower cerebral activations in the right superior temporal gyrus (BA 42), right and left middle frontal gyrus (BA 6), right postcentral gyrus (BA 3) and left inferior frontal gyrus (BA 9). We interpreted such neural changes as normalization of previously abnormal hyperactivations.
Cognitive Telerehabilitation with Transcranial Direct Current Stimulation Improves Cognitive and Emotional Functioning Following a Traumatic Brain Injury: A Case Study. [2021]Cognitive deficits following a traumatic brain injury (TBI) are a leading cause of disability in young adults and there is a critical need for novel approaches to improve cognitive outcomes in TBI survivors. Transcranial direct current stimulation (tDCS) paired with cognitive remediation has emerged as a viable, cost-effective, noninvasive approach for treating cognitive impairments in a wide variety of neurological conditions. Here, we report the first case study utilizing remotely supervised tDCS (RS-tDCS) protocol paired with cognitive remediation in a 29-year-old man with persisting cognitive and emotional sequelae following TBI.
Brain stimulation in attention deficits after traumatic brain injury: a literature review and feasibility study. [2021]After a traumatic brain injury, disturbances in the attentional processes have a direct negative effect on functional recovery and on return to complex activities. To date, there is no good attention remediation treatment available. The primary objective of this review and pilot study is to provide an overview of the research evidence and to evaluate the feasibility of implementing a tDCS protocol to improve attention disorders in patients with mild complicated to severe subacute TBI, hospitalized in an inpatient rehabilitation facility. Our secondary objective is to extract preliminary data and observational information on participants' response to treatment.
Transcranial direct current stimulation modulates working memory and prefrontal-insula connectivity after mild-moderate traumatic brain injury. [2023]Background: Persistent posttraumatic symptoms (PPS) may manifest after a mild-moderate traumatic brain injury (mmTBI) even when standard brain imaging appears normal. Transcranial direct current stimulation (tDCS) represents a promising treatment that may ameliorate pathophysiological processes contributing to PPS. Objective/Hypothesis: We hypothesized that in a mmTBI population, active tDCS combined with training would result in greater improvement in executive functions and post-TBI cognitive symptoms and increased resting state connectivity of the stimulated region, i.e., left dorsolateral prefrontal cortex (DLPFC) compared to control tDCS. Methods: Thirty-four subjects with mmTBI underwent baseline assessments of demographics, symptoms, and cognitive function as well as resting state functional magnetic resonance imaging (rsfMRI) in a subset of patients (n = 24). Primary outcome measures included NIH EXAMINER composite scores, and the Neurobehavioral Symptom Inventory (NSI). All participants received 10 daily sessions of 30 min of executive function training coupled with active or control tDCS (2 mA, anode F3, cathode right deltoid). Imaging and assessments were re-obtained after the final training session, and assessments were repeated after 1 month. Mixed-models linear regression and repeated measures analyses of variance were calculated for main effects and interactions. Results: Both active and control groups demonstrated improvements in executive function (EXAMINER composite: p < 0.001) and posttraumatic symptoms (NSI cognitive: p = 0.01) from baseline to 1 month. Active anodal tDCS was associated with greater improvements in working memory reaction time compared to control (p = 0.007). Reaction time improvement correlated significantly with the degree of connectivity change between the right DLPFC and the left anterior insula (p = 0.02). Conclusion: Anodal tDCS improved reaction time on an online working memory task in a mmTBI population, and decreased connectivity between executive network and salience network nodes. These findings generate important hypotheses for the mechanism of recovery from PPS after mild-moderate TBI.
Effects of repeated anodal tDCS coupled with cognitive training for patients with severe traumatic brain injury: a pilot randomized controlled trial. [2022]To determine whether cumulative anodal transcranial direct current stimulation (A-tDCS) of the left dorsolateral prefrontal cortex (DLPFC) could enhance rehabilitation of memory and attention in patients with traumatic brain injury (TBI).
Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study. [2022]Transcranial direct current stimulation (tDCS) is a potentially novel strategy for cognitive enhancement in patients with mild or major neurocognitive disorders. This study aims to assess the safety and efficacy of tDCS during cognitive training on cognitive functioning in patients with mild or major neurocognitive disorders.
Optimized high-definition tDCS in patients with skull defects and skull plates. [2023]Transcranial direct current stimulation (tDCS) has been shown to benefit patients with brain lesions or traumatic brain injury (TBI). These patients usually have skull defects with different sizes and electrical conductivities. There is very little data in the literature that show how to optimally stimulate these patients with the presence of skull defects.
Effects of transcranial direct current stimulation on patients with disorders of consciousness after traumatic brain injury: study protocol for a randomized, double-blind controlled trial. [2020]Disorders of consciousness (DOC) after traumatic brain injury (TBI) raise the mortality of patients, restrict the rehabilitation of patients with TBI, and increase the physical and economic burden that TBI imposes on patients and their families. Thus, treatment to promote early awakening in DOC after TBI is of vital importance. Various treatments have been reported, but there is no advanced evidence base to support them. Transcranial direct current stimulation (tDCS) has shown great potential in promoting neuroelectrochemical effects. This protocol is for a double-blind, randomized, controlled, clinical trial aiming to research the effects and safety of conventional rehabilitation combined with tDCS therapy in patients with DOC after TBI.
Transcranial direct current stimulation in combination with cognitive training in individuals with mild cognitive impairment: a controlled 3-parallel-arm study. [2022]Several studies showed that transcranial direct current stimulation (tDCS) enhances cognition in patients with mild cognitive impairment (MCI), however, whether tDCS leads to additional gains when combined with cognitive training remains unclear. This study aims to compare the effects of a concurrent tDCS-cognitive training intervention with either tDCS or cognitive training alone on a group of patients with MCI.
High-definition transcranial direct current stimulation modulates theta response during a Go-NoGo task in traumatic brain injury. [2023]High Definition transcranial Direct Current Stimulation (HD-tDCS) has been shown to improve cognitive performance in individuals with chronic traumatic brain injury (TBI), although electrophysiological mechanisms remain unclear.
Transcranial direct current stimulation (tDCS) effects on traumatic brain injury (TBI) recovery: A systematic review. [2022]Traumatic brain injury (TBI) is a major cause of chronic disability. Less than a quarter of moderate and severe TBI patients improved in their cognition within 5 years. Non-invasive brain stimulation, including transcranial direct current stimulation (tDCS), may help neurorehabilitation by boosting adaptive neuroplasticity and reducing pathological sequelae following TBI.