Brain Stimulation + Cognitive Training for TBI
(ReSTART Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether combining brain stimulation with cognitive training can improve thinking skills such as attention, memory, and decision-making in older adults who have experienced a mild traumatic brain injury (TBI). Participants will engage in brain exercises while receiving either active or placebo brain stimulation (transcranial direct current stimulation, or tDCS) to determine which is more effective. The trial aims to assess whether this kind of home-based program is practical and appealing for older adults. It is suitable for veterans aged 65 and older who have had mild TBI and currently experience attention or concentration difficulties. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cognitive health in older adults.
Do I need to stop my current medications for the trial?
You don't need to stop your current medications, but they must be stable for at least 3 weeks before starting the trial. This means you should not change the dose or start new medications that affect thinking or brain chemistry during that time.
What prior data suggests that this brain stimulation and cognitive training program is safe for older adults with TBI?
Research has shown that transcranial direct current stimulation (tDCS), a type of brain stimulation, is generally safe for people with traumatic brain injury (TBI). One study found that tDCS did not cause serious side effects, such as damage to brain tissue. Another study examined individuals with severe TBI and found that a single session of tDCS was well-tolerated.
These findings suggest that tDCS is a safe option for improving cognitive functions like attention and memory. While further research remains important, current evidence supports the safety of tDCS for those considering participation in the trial.12345Why are researchers excited about this trial?
Researchers are excited about using transcranial direct current stimulation (tDCS) combined with cognitive training for traumatic brain injury (TBI) because it offers a novel approach to enhancing brain function. Unlike traditional TBI treatments, which often focus on medications or physical therapy, tDCS directly stimulates the brain with a mild electrical current, potentially boosting cognitive recovery. This technique is non-invasive, meaning it doesn't require surgery or medication, and it can be precisely targeted to specific brain regions. By pairing it with cognitive training, there's potential for more significant improvements in attention, memory, and problem-solving skills, providing a fresh avenue for TBI recovery.
What evidence suggests that combining brain stimulation with cognitive training is effective for improving thinking skills in older adults with TBI?
Research has shown that transcranial direct current stimulation (tDCS) can improve memory and attention in people with brain injuries. Studies have found that tDCS enhances thinking abilities and mood in patients with traumatic brain injuries (TBI). By sending gentle electrical currents to the brain, it may help the brain change and adapt. This trial will compare two approaches: one group will receive active tDCS with cognitive training, while another group will receive sham tDCS with cognitive training. This type of brain stimulation has also improved thinking skills after strokes. Therefore, using tDCS with cognitive training might help older adults with TBI enhance their thinking abilities.678910
Are You a Good Fit for This Trial?
This trial is for older adults who have experienced a traumatic brain injury (TBI) and are noticing changes in their thinking skills. Participants should be able to complete training at home and attend assessments before and after the program.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete baseline assessments of cognitive function, daily living skills, and quality of life
Treatment
Participants undergo 10 sessions of cognitive training with either active or sham tDCS
Follow-up
Participants complete follow-up assessments to measure changes in thinking, decision-making, and daily functioning
What Are the Treatments Tested in This Trial?
Interventions
- tDCS
Trial Overview
The study is testing if brain stimulation (tDCS) alongside cognitive training improves attention, memory, and decision-making in seniors with TBI. One group gets real tDCS; the other gets sham tDCS during computer-based exercises.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (45 minutes of cognitive training with tDCS applied for first 20 minutes of session; tDCS: 2mA, 30s ramp up/down, anode at F3, cathode at F4).
Participants will receive 10 sessions of cognitive training concurrent with sham transcranial direct current stimulation (45 minutes of cognitive training with sham tDCS: 2mA 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, anode at F3, cathode at F4).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Minneapolis Veterans Affairs Medical Center
Lead Sponsor
Center for Veterans Research and Education
Collaborator
Citations
Transcranial direct current stimulation (tDCS) effects on ...
Less than a quarter of moderate and severe TBI patients improved in their cognition within 5 years. Non-invasive brain stimulation, including transcranial ...
2.
frontiersin.org
frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1552387/fullTranscranial direct current stimulation in individuals with ...
Research has demonstrated positive results from the application of tDCS after stroke, such as improved motor and cognitive function, when tDCS ...
"Cognitive Rehabilitation With Direct Current Transcranial ...
Transcranial Direct Current Stimulation (tDCS) has shown effectiveness in enhancing neuroplasticity in various neurological and psychiatric conditions 63.
Effectiveness of rTMS and tDCS treatment for chronic TBI ...
This study aims at providing a systematic review and meta-analysis on the effectiveness of repetitive transcranial magnetic stimulation (TMS) and transcranial ...
Effect of Transcranial Direct Current Stimulation on Memory ...
Conclusions: tDCS effectively improved emotional states, reduced depression levels, and enhanced cognitive functions in AIS and TBI patients. These findings ...
Transcranial direct current stimulation in individuals with ...
Studies showing positive results from tDCS after TBI were carried out on individuals in the chronic phase of trauma (Yan et al., 2020), ...
The safety and feasibility of transcranial direct current ...
Our phase I safety study indicated that a single course of tDCS was safe in patients with severe traumatic brain injury.
Transcranial Direct Current Stimulation (TDCS) as an ...
The primary aim of this study is to assess the magnitude of tDCS-induced cognitive and functional change in patients with mild traumatic brain injury (TBI).
Safety of transcranial Direct Current Stimulation: Evidence ...
In this review, tDCS safety indicates the absence of a Serious Adverse Effect including brain tissue injury related to tDCS application. It is necessary to ...
Transcranial direct current stimulation promotes ...
Transcranial Direct Current Stimulation Improves Some Neurophysiological Parameters but not Clinical Outcomes after Severe Traumatic Brain Injury. J Integr ...
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