Brain Stimulation for Traumatic Brain Injury

(STIM-CTBI Trial)

Overseen By Iris Hall, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Stroke, Epilepsy, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 25

Duration: 2 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if transcranial direct current stimulation (tDCS), which sends small electrical currents to the brain, can help people with traumatic brain injury (TBI) improve memory and word-finding abilities. Participants will receive either active brain stimulation or a sham (pretend) version to compare effects. It is ideal for those who have had a TBI for at least a year and experience word-finding issues. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance cognitive recovery for TBI patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently undergoing speech and cognitive therapy and do not wish to stop, you cannot participate in the study.

What prior data suggests that this brain stimulation technique is safe for people with traumatic brain injury?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for people with traumatic brain injury (TBI). One study found that a single session of tDCS was well-tolerated by patients with severe TBI, with no serious side effects. Another study demonstrated that tDCS improved thinking skills without causing major problems. Although tDCS has been tested in various conditions over time, each study confirms its safety and effectiveness. However, discussing potential risks with a doctor before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for traumatic brain injury, which often involve medication or rehabilitation therapies, transcranial direct current stimulation (tDCS) offers a non-invasive approach by using a mild electrical current to modulate brain activity. Researchers are excited about tDCS because it targets specific brain regions directly, potentially enhancing neural plasticity and recovery processes. Additionally, tDCS can be easily administered, making it a versatile option that might complement existing therapies without significant side effects. This method holds promise for improving outcomes more efficiently and effectively than current standard treatments.

What evidence suggests that transcranial direct current stimulation is effective for word finding problems in traumatic brain injury?

Studies have shown that transcranial direct current stimulation (tDCS) can improve thinking skills, such as memory and word-finding, in people with traumatic brain injury (TBI). Research indicates that tDCS sends a small electric current to specific brain areas, boosting brain activity. In earlier studies, individuals with TBI experienced emotional improvement and clearer thinking after tDCS treatment. In this trial, participants will receive either active tDCS followed by sham stimulation or sham stimulation followed by active tDCS. These findings suggest that tDCS may assist with memory and word-finding difficulties in TBI patients. Overall, this treatment shows promise in aiding brain recovery and function. ^{1 3 4 6 7}

Who Is on the Research Team?

Hsueh-Sheng Chiang, MD, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-85 with a non-military traumatic brain injury (TBI) at least one year old, who have trouble finding words. They must be able to consent and travel to the study center. Excluded are those with substance abuse, major psychiatric or heart conditions, severe sensory/physical impairments, recent severe depression or neurologic issues, pregnancy, or ongoing speech therapy they don't want to pause.

Inclusion Criteria

Fluent in speaking and reading English

Able to provide informed consent

I had a traumatic brain injury over a year ago, not from military service.

Exclusion Criteria

Current substance use disorder

Lifetime major psychiatric disorders (e.g., schizophrenia, bipolar disorder)

I do not have any major or active heart conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline EEG and neuropsychological tasks, including an MRI session

1 week

1 visit (in-person)

Treatment

Participants receive 10 sessions of active or sham HD-tDCS over 2 weeks

2 weeks

10 visits (in-person)

Immediate Follow-up

EEG and neuropsychological tasks are completed immediately after the last HD-tDCS session

1 week

1 visit (in-person)

2-Month Follow-up

Participants are monitored for changes in verbal retrieval function and cognitive performance

2 months

1 visit (in-person)

Crossover Treatment

Participants receive the alternate treatment (active or sham) and undergo the same assessments

2 weeks

10 visits (in-person)

Immediate Follow-up (Crossover)

EEG and neuropsychological tasks are completed immediately after the last crossover HD-tDCS session

1 week

1 visit (in-person)

2-Month Follow-up (Crossover)

Participants are monitored for changes in verbal retrieval function and cognitive performance after crossover treatment

2 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview

The study tests if transcranial direct current stimulation (tDCS), which sends low electric currents via scalp electrodes to the brain can improve word recall in TBI patients. Participants will receive either active tDCS or a sham (placebo) treatment without knowing which one they're getting.

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?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) has been found to be safe for use in humans, with no severe complications reported in studies involving both adults and children when applied at intensities of 4 mA or less for up to 60 minutes.

Animal studies indicate that the electrical current used in tDCS is significantly lower than the threshold that could cause permanent changes to brain tissue, suggesting a strong safety profile for this neurorehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. Ko, MH.[2023]

Brain stimulation techniques, particularly transcranial direct current stimulation, show promise in promoting recovery from traumatic brain injury (TBI), especially in chronic phases, but evidence for acute phase efficacy and safety is still limited.

Most current brain stimulation interventions are non-targeted and lack sufficient clinical trials, highlighting the need for larger, well-designed studies to better understand their potential benefits in enhancing neuroplasticity and functional outcomes after TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of brain stimulation modalities following traumatic brain injury: current evidence. Li, S., Zaninotto, AL., Neville, IS., et al.[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) 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]

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]

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 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]

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]

Citations

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