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

Trial Summary

What is the purpose of this trial?

The two goals of the proposed study are: (1) To determine how brain activity changes with cognitive recovery over time from acute to chronic phases of traumatic brain injury (TBI). (2) To determine how the time of anodal transcranial electrical stimulation (A-tES) administration affects cognitive performance and brain activity in TBI. To achieve these study goals, the investigators will conduct a pilot clinical trial over three years in which the investigators aim to recruit 60 patients with moderate to severe TBI at the University of Cincinnati Medical Center (UCMC). During the acute phase of TBI, all participants will complete clinical questionnaires and perform 2 cognitive computer tasks while their brain activity is recorded. Half of the participants will be randomly selected to receive A-tES for 15 minutes while performing cognitive tasks and the other half will receive sham stimulation. All participants will be followed for 6 months. During their 3-month follow-up, the investigators will perform another session where all participants complete the questionnaires and receive A-tES while performing cognitive tasks during brain recording. In their last visit at 6 months post-injury, all participants will complete the questionnaires and cognitive tasks with brain recording but no stimulation treatment. From the collected data, the investigators will determine if time from brain injury correlates with brain activity during performance of cognitive tasks. The investigators will also assess the efficacy of early A-tES treatment for improving cognitive task performance and clinical test ratings at 6 months post-injury in comparison to A-tES delivered during the 3-month follow-up visit.

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 data supports the effectiveness of the treatment Anodal Transcranial Electrical Stimulation for Traumatic Brain Injury?

Research suggests that transcranial electrical stimulation, including anodal transcranial direct current stimulation, can improve attention and motor recovery in patients with traumatic brain injury. Studies in rats and humans have shown potential benefits in brain function and recovery, indicating that this treatment might help improve outcomes after brain injury. ^{1 2 3 4 5}

Is transcranial electrical stimulation safe for humans?

Transcranial electrical stimulation (tES) is generally considered safe for humans, with no serious adverse events reported in over 18,000 sessions. Mild side effects like headaches and skin sensations are possible, but serious issues are rare. ^{6 7 8 9 10}

How does anodal transcranial electrical stimulation differ from other treatments for traumatic brain injury?

Anodal transcranial electrical stimulation is unique because it involves applying a small electrical current to the brain non-invasively, which can improve attention in traumatic brain injury patients by targeting specific brain areas like the prefrontal cortex. Unlike traditional drug treatments, this method directly influences brain activity and connectivity, potentially offering a personalized approach based on individual brain structure. ^{2 4 9 11 12}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

The effect of electric cortical stimulation after focal traumatic brain injury in rats. [2021]

2. Sweden 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. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical utility of brain stimulation modalities following traumatic brain injury: current evidence. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Changes in spontaneous brain bioelectrical activity during transcranial electrical and electromagnetic stimulation. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Short-Term Cortical Electrical Stimulation during the Acute Stage of Traumatic Brain Injury Improves Functional Recovery. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]

8. Italy pubmed.ncbi.nlm.nih.gov

Blinding efficacy and adverse events following repeated transcranial alternating current, direct current, and random noise stimulation. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Classification of methods in transcranial electrical stimulation (tES) and evolving strategy from historical approaches to contemporary innovations. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Transcranial electrical stimulation nomenclature. [2020]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Trans-CSF electrostimulation of the brain in patients with posttraumatic vegetative state (theoretical basis and preliminary results)]. [2010]

12. England pubmed.ncbi.nlm.nih.gov

Traumatic axonal injury influences the cognitive effect of non-invasive brain stimulation. [2023]