Transcranial Electrical Stimulation for Traumatic Brain Injury

Overseen By Ishita Basu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Non-survivable injury, Pregnancy, Polytrauma, Seizures, others

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

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how anodal transcranial electrical stimulation (A-tES) might aid in recovering thinking skills after a traumatic brain injury (TBI). Researchers aim to observe changes in brain activity from the initial injury to later stages and determine if early A-tES treatment improves cognitive performance. Participants with moderate to severe TBI will receive either this stimulation shortly after their injury or a placebo treatment for comparison. Suitable candidates are those who have experienced moderate to severe TBI, resulting in significant memory loss or confusion lasting over a day. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance recovery options 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 transcranial electrical stimulation is safe for traumatic brain injury patients?

Research shows that anodal transcranial electrical stimulation (A-tES) is generally safe. Studies have found that a single session of transcranial direct current stimulation (tDCS), similar to A-tES, is well-tolerated by patients with severe traumatic brain injury (TBI). Although limited information exists on the safety of A-tES in the early stages of TBI, existing studies suggest it doesn't cause serious side effects. Most people experience mild sensations like tingling on the scalp, but these are temporary and not harmful. Overall, while more research is needed, A-tES appears to be a safe option for those recovering from TBI. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about anodal transcranial electrical stimulation (A-tES) for traumatic brain injury because it offers a unique, non-invasive approach. Unlike standard treatments that often involve medication and rehabilitation therapy, A-tES uses electrical currents to stimulate brain activity, potentially aiding recovery. This method is particularly appealing because it can be administered early after the injury and is repeated at follow-up, possibly enhancing its effectiveness. Additionally, its non-invasive nature means it's generally safer and more accessible than surgical options, providing a promising alternative for patients.

What evidence suggests that anodal transcranial electrical stimulation is effective for traumatic brain injury?

Research has shown that anodal transcranial electrical stimulation (A-tES), a treatment participants in this trial may receive, might improve thinking skills after a traumatic brain injury (TBI). Studies have found that people with TBI who received this treatment experienced better memory. Another study found that similar electrical stimulation techniques also enhanced thinking skills. Although specific evidence for A-tES in TBI remains limited, these findings suggest it could aid brain recovery. Overall, early signs are promising for using A-tES to boost brain function after injury. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-80 who have experienced a moderate to severe traumatic brain injury, as indicated by specific scores on the Glasgow Coma Scale and other criteria. They must be able to speak clearly and show certain levels of orientation and memory function at enrollment.

Inclusion Criteria

Intelligible speech and Galveston Orientation and Amnesia Test (GOAT) score >70 at time of enrollment

I have had a traumatic brain injury.

I had a severe head injury with significant consciousness loss or memory issues.

Exclusion Criteria

Pregnancy

Patients with polytrauma

Persistent bilateral non-reactive pupils or other evidence of non-survivable injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Acute Phase Treatment

Participants perform cognitive tasks with EEG recording; half receive active A-tES and half receive sham stimulation

1-2 weeks

1 visit (in-person)

3-Month Follow-up

Participants perform cognitive tasks with EEG recording and receive active A-tES

1 day

1 visit (in-person)

6-Month Follow-up

Participants perform cognitive tasks with EEG recording and complete quality of life questionnaire

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Anodal Transcranial Electrical Stimulation
• Sham Comparator

Trial Overview The study tests how anodal transcranial electrical stimulation (A-tES) affects cognitive performance in TBI patients. Participants are split into two groups: one receives A-tES while doing cognitive tasks, the other gets sham stimulation. Their brain activity is monitored over six months.

How Is the Trial Designed?

Group I: Early intervention Experimental Treatment 1 Intervention

Patients assigned to this arm will receive anodal transcranial electrical stimulation (A-tES) within a 1-2 weeks of their injury and another session of tES at a 3 month follow up visit.

Group II: Sham Placebo Group 1 Intervention

Patients assigned to this arm will receive sham transcranial electrical stimulation (tES) within a 1-2 weeks of their injury and another session of tES at a 3 month follow up visit.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Published Research Related to This Trial

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]

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]

Low intensity transcranial electrical stimulation (TES) is considered safe, with no serious adverse events reported in over 18,000 sessions across various populations, including healthy individuals and patients with neurological or psychiatric conditions.

While moderate adverse events like skin burns from tDCS are rare, mild adverse events such as headaches and fatigue are more common, and the safety profile is consistent across different age groups and vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Antal, A., Alekseichuk, I., Bikson, M., et al.[2023]

Transcranial electrical stimulation (tES), including tDCS and MHF-tPCS, was found to be well tolerated in healthy subjects over a six-week period, with common side effects being mild skin sensations like tingling and itching, which were less frequent than in the sham-tDCS group.

The MHF-tPCS group showed significantly higher compliance in completing sessions compared to the sham-tDCS group, indicating that this waveform may be more acceptable for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects. Paneri, B., Adair, D., Thomas, C., et al.[2018]

In a study involving 1,019 participants across 4 sites, adverse events (AEs) following multiple sessions of transcranial electrical stimulation (tES) were found to be influenced more by factors like testing site and session number rather than the stimulation itself, suggesting a good safety profile for repeated use.

The effectiveness of blinding procedures was found to be less reliable for tDCS and tACS compared to tRNS, indicating a need for improved blinding methods, especially when using higher stimulation intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blinding efficacy and adverse events following repeated transcranial alternating current, direct current, and random noise stimulation. Sheffield, JG., Ramerpresad, S., Brem, AK., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6601308/

Transcranial direct current stimulation (tDCS) effects on ... Multiple studies showed improved coma recovery scales in disorders of consciousness, and improved cognition on neuropsychological assessments.

2. uc.edu uc.edu/news/articles/2024/12/uc-trial-to-test-electrical-stimulation-of-the-brain-after-tbi.html

UC trial to test electrical stimulation of the brain after TBI “There is limited evidence available for efficacy and safety of brain stimulation in improving cognitive outcomes during acute stages of TBI, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022510X16300703

Effects of anodal transcranial direct current stimulation ... A recent trial found that patients with subacute traumatic brain injury (TBI) improved memory function after the application of anodal tDCS [16] ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06228872

"Cognitive Rehabilitation With Direct Current Transcranial ... The goal of this clinical trial is to investigate the impact of daily self-administered transcranial direct current stimulation (tDCS) therapy on the ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01159-y

Electrical stimulation methods and protocols for the ... In this review, we present the state-of-the-art in preclinical research on electrical stimulation methods used to treat TBI sequelae.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03882502

Electrical Stimulation in Traumatic Brain Injury (TBI) ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06871124/early-neuromodulation-in-traumatic-brain-injury?id=278&slug=neurologic-disorders

Early Neuromodulation in Traumatic Brain Injury In the acute stages, there is limited available evidence of the efficacy and safety of brain stimulation to improve outcomes. The stimulation ...

8. 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.