Transcranial Direct Current Stimulation for Traumatic Brain Injury

Overseen By Jill Ritter, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Dallas

Disqualifiers: Dementia, Epilepsy, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

Duration: 2-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a gentle electric stimulation technique, called transcranial Direct Current Stimulation (tDCS), can improve memory recall in individuals who have experienced a traumatic brain injury (TBI). Participants will receive either active or sham (fake) stimulation to determine any noticeable differences in memory and other cognitive skills. The trial seeks individuals who suffered a TBI over a year ago and have since experienced difficulty finding words. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance cognitive recovery for TBI patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for improving verbal retrieval in individuals with traumatic brain injuries?

Research has shown that transcranial Direct Current Stimulation (tDCS) is generally safe for people with traumatic brain injuries. One study found that a single session of tDCS did not cause serious side effects in patients. Other research provides promising evidence that tDCS is safe and can help improve thinking skills in people with various brain injuries. So far, participants have tolerated the treatment well. This suggests it might be a safe option for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to treating traumatic brain injury (TBI) using High Definition Transcranial Direct Current Stimulation (HD-tDCS). Unlike traditional treatments that often involve medication or physical therapy, HD-tDCS delivers a gentle electrical current directly to the brain, potentially enhancing neuroplasticity and aiding recovery. This method is non-invasive and can be precisely targeted to specific brain areas, which could lead to more effective results with fewer side effects. By comparing active and sham stimulation, researchers hope to better understand the true impact of HD-tDCS on TBI recovery, paving the way for innovative treatment options.

What evidence suggests that transcranial Direct Current Stimulation is effective for improving verbal retrieval in traumatic brain injury?

Research has shown that High Definition Transcranial Direct Current Stimulation (HD-tDCS) can improve thinking skills in people with long-term traumatic brain injuries (TBIs). Studies have found it aids brain functions related to memory and attention. In this trial, participants will receive different sequences of active and sham HD-tDCS to evaluate its effectiveness. Although research is ongoing, HD-tDCS appears to be a safe and effective method for enhancing thinking abilities in people with varying levels of TBI. This treatment targets specific brain areas to potentially improve memory and other mental skills, offering hope for those facing challenges due to TBI. ^{3 5 6 7 8}

Who Is on the Research Team?

John Hart, MD

Principal Investigator

The University of Texas at Dallas

Are You a Good Fit for This Trial?

This trial is for civilian adults with a history of traumatic brain injury who struggle to find words (anomia). They should not be military or veterans. Participants must be able to undergo neuropsychological assessments and EEG measures, and have no other conditions that could interfere with the study.

Inclusion Criteria

Participants have had a traumatic brain injury more than a year ago prior to study participation

I have trouble finding words due to a brain injury, confirmed by tests.

Participants are non-military personnel and not veterans

Exclusion Criteria

I have a defect in my skull.

Presence of an implanted/electronic device such as a pacemaker, metallic cranial or intracranial implant (e.g., ventriculoperitoneal shunt), or a neurostimulator (e.g., vagus nerve stimulator, spinal stimulator, deep brain stimulator, etc.)

Currently pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham transcranial direct current stimulation (tDCS) for 20 minutes over 10 sessions

2-4 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2-months post-treatment

8 weeks

1 visit (in-person)

Second Treatment

Participants are re-assigned to the opposite treatment condition (active or sham) for another 20 minutes over 10 sessions

2-4 weeks

10 visits (in-person)

Second Follow-up

Participants are monitored again for safety and effectiveness after the second treatment, with assessments at 2-months post-treatment

8 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High Definition Transcranial Direct Current Stimulation

Trial Overview The study tests if low-level electric stimulation (active tDCS) on a specific brain area improves word finding abilities compared to sham (fake) stimulation. It includes verbal retrieval tests as primary outcome measures, other cognitive ability tests, and EEG monitoring before and after treatment.

How Is the Trial Designed?

Group I: Sham to Active transcranial direct current stimulation Experimental Treatment 2 Interventions

Subjects in this arm will first be randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects will be assigned to active stimulation.

Group II: Active to Sham Transcranial direct current stimulation Experimental Treatment 2 Interventions

Subjects in this arm will first be randomly assigned to receive active stimulation. After completion of active stimulation, subjects will be assigned to sham stimulation.

Who Is Running the Clinical Trial?

The University of Texas at Dallas

Lead Sponsor

Trials

71

Recruited

108,000+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Transcranial direct current stimulation (tDCS) appears to be safe and well-tolerated in youth, based on a synthesis of studies involving 156 children and a total of 864 active sessions.

The reviewed literature supports the acceptability of tDCS in pediatric populations, with only a small percentage of sessions (4.4%) conducted on neurotypical controls, indicating a focus on clinical subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review on the Safety and Tolerability of Transcranial Direct Current Stimulation in Children and Adolescents. Buchanan, DM., Bogdanowicz, T., Khanna, N., et al.[2021]

High-Definition transcranial Direct Current Stimulation (HD-tDCS) at amplitudes up to 4 mA was well tolerated by 292 older adults, with no safety-related adverse events reported and mostly mild sensations experienced during sessions.

The study demonstrated effective blinding for both participants and researchers, indicating that the sham stimulation was convincing, which supports the use of higher amplitudes for potentially greater therapeutic effects in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode. El Jamal, C., Harrie, A., Rahman-Filipiak, A., et al.[2023]

Optimized high-definition montages for transcranial direct current stimulation (tDCS) can increase stimulation intensity by an average of 0.3 V/m compared to unoptimized montages, which is crucial for targeting areas beneath skull defects.

Large skull defects with titanium or acrylic plates can reduce stimulation intensity by about 80%, while smaller defects filled with cerebrospinal fluid or scar tissue can increase stimulation intensity by about 200%, highlighting the importance of individual anatomical considerations in tDCS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimized high-definition tDCS in patients with skull defects and skull plates. Guillen, A., Truong, DQ., Datta, A., et al.[2023]

Transcranial direct current stimulation (tDCS) may enhance cognitive and motor training effects in patients with traumatic brain injuries or those who have undergone decompressive craniectomy, but the presence of skull defects can alter the effectiveness of the treatment.

Modeling with MRI-derived finite element head models showed that the impact of skull defects on electric current flow depends on various factors, such as electrode position and defect size, indicating that careful consideration is needed to ensure safety and efficacy in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in patients with skull defects and skull plates: high-resolution computational FEM study of factors altering cortical current flow. Datta, A., Bikson, M., Fregni, F.[2021]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

A single session of anodal transcranial direct current stimulation (tDCS) to the left dorsolateral prefrontal cortex showed a tendency to improve reaction times in patients with traumatic brain injury, suggesting potential benefits for attention improvement.

While the immediate effects were promising, the improvements were not statistically significant after 3 or 24 hours, indicating that further research is needed to confirm the efficacy of tDCS in enhancing attention in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation of the left prefrontal cortex improves attention in patients with traumatic brain injury: a pilot study. Kang, EK., Kim, DY., Paik, NJ.[2022]

In a study involving 20 patients with posttraumatic encephalopathy, high-definition transcranial direct current stimulation (HD-tDCS) significantly improved cerebral blood flow (CBF) and cerebral blood volume (CBV), indicating enhanced oxygen delivery to brain tissue.

The treatment also reduced areas of hypoperfusion and ischemia, suggesting that HD-tDCS may be an effective non-pharmacologic intervention for improving cerebral perfusion after traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral Hemodynamics After Transcranial Direct Current Stimulation (tDCS) in Patients with Consequences of Traumatic Brain Injury. Trofimov, AO., Kalentiev, G., Karelsky, M., et al.[2020]

Transcranial direct current stimulation (tDCS) did not show significant improvements in motor performance for all stroke patients immediately after treatment, but it did demonstrate effectiveness in enhancing motor function for patients with chronic stroke and mild-to-moderate impairments, based on a review of 15 studies with 315 subjects.

The results suggest that while tDCS has potential as a therapeutic tool in stroke recovery, its efficacy varies based on stroke characteristics, indicating that more research is needed to optimize its use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS): does it have merit in stroke rehabilitation? A systematic review. Marquez, J., van Vliet, P., McElduff, P., et al.[2022]

In a study involving veterans with chronic traumatic brain injury (TBI), active high-definition transcranial direct current stimulation (HD-tDCS) significantly improved cognitive performance, as evidenced by increased theta activity in the brain during a Go-NoGo task, compared to a sham treatment.

The results suggest that HD-tDCS induces specific changes in brain oscillatory activity, which could help identify individuals who are more likely to benefit from this type of intervention in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-definition transcranial direct current stimulation modulates theta response during a Go-NoGo task in traumatic brain injury. Chiang, HS., Motes, M., Kraut, M., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36108520/

High-definition transcranial direct current stimulation ... High Definition transcranial Direct Current Stimulation (HD-tDCS) has been shown to improve cognitive performance in individuals with chronic traumatic brain ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1388245722008690

High-definition transcranial direct current stimulation ... High Definition transcranial Direct Current Stimulation (HD-tDCS) has been shown to improve cognitive performance in individuals with chronic traumatic brain ...

3. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1172218.pdf

High-Definition Transcranial Direct Current Stimulation (HD ... During this reporting period, preliminary data has been generated demontrating improvements in neurosensory function, cognitive control, and ...

4. frontiersin.org frontiersin.org/journals/neuroergonomics/articles/10.3389/fnrgo.2023.1170473/full

A map of evidence using transcranial direct current ... Limited but promising evidence supports tDCS as safe and effective for cognition across all levels of TBI acuity and severity (Begemann et al., ...

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05408975

NCT05408975 | Treating Civilian Traumatic Brain Injury ... Using two treatment arms, the study will examine improvement of verbal retrieval and other cognitive deficits associated with remote traumatic brain injury by ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12061881/

Transcranial direct current stimulation in individuals with ... The aim of this study is to report clinical cases of patients with severe traumatic brain injury (TBI) who underwent transcranial direct current stimulation ( ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666459324000088

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.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05408975

Treating Civilian Traumatic Brain Injury With High ... The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain ...