HD-tDCS for Electrocution

Overseen By Ji Hyun Ko, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Neurological, Psychiatric, Seizures, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

Trial Summary

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

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.

What data supports the effectiveness of the treatment HD-tDCS for electrocution?

Research shows that HD-tDCS, a type of brain stimulation, can enhance treatment outcomes in conditions like stroke and brain injuries by improving neural modulation, which means it helps the brain work better. While not directly related to electrocution, these findings suggest potential benefits in improving brain function. ^{1 2 3 4 5}

Is HD-tDCS generally safe for humans?

HD-tDCS and tDCS are generally considered safe and well-tolerated, but there are concerns about potential harmful effects, especially at higher intensities or in healthy individuals. Some studies report low and temporary side effects, but caution is advised. ^{2 6 7 8 9}

How is HD-tDCS treatment different from other treatments for electrocution?

HD-tDCS is unique because it uses small, high-definition electrodes to deliver a focused electrical current to specific brain areas, which may allow for more precise neural modulation compared to traditional methods. This non-invasive technique is different from other treatments as it aims to enhance brain function without the need for medication or surgery. ^{1 2 3 4 10}

What is the purpose of this trial?

The purpose of the proposed study is to broaden our understanding on the neural effects of High Definition Transcranial Direct Current Stimulation (HD-tDCS) so that its clinical effects can be further improved.

Eligibility Criteria

This trial is open to individuals who have experienced electrocution but do not have any neurological or psychiatric diseases, especially seizures. Participants should not have metal implants, cardiac pacemakers, and must not be pregnant or breastfeeding. An abnormal MRI also disqualifies someone from participating.

Inclusion Criteria

All other than excluded.

Exclusion Criteria

History of metal implants or a cardiac pacemaker

History of abnormal MRI

Pregnant or breastfeeding women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo HD-tDCS during MRI with neuropsychological assessments before and after stimulation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in functional connectivity and cerebral blood flow after stimulation

1-2 hours

1 visit (in-person)

Treatment Details

Interventions

• HD-tDCS

Trial Overview The study is examining the effects of a brain stimulation technique called high definition transcranial direct current stimulation (HD-tDCS) on neural connectivity to improve its clinical applications.

Participant Groups

Group I: right DLPFC stimulation Experimental Treatment 1 Intervention

HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels. The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the right dorsolateral prefrontal cortex (DLPFC; x=+42, y=+14, z=+30) with inward field orientation. The peak current will not exceed 2 mA. A constant current will be delivered for 20 minutes.

Group II: left IPL stimulation Experimental Treatment 1 Intervention

HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels. The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left intraparietal lobe (IPL; x=-50, y=-36, z=+42) with inward field orientation. The peak current will not exceed 2 mA. A constant current will be delivered for 20 minutes.

Group III: left DLPFC stimulation Experimental Treatment 1 Intervention

HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels. The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left dorsolateral prefrontal cortex (DLPFC; x=-44, y=10, z=30) with inward field orientation. The peak current will not exceed 2 mA. A constant current will be delivered for 20 minutes.

Group IV: VLPFC-PCC stimulation Experimental Treatment 1 Intervention

HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels. The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left ventrolateral prefrontal cortex (VLPFC; x=-50, y=+26, z=+8) and posterior cingulate cortex (PCC; x=1, y=-61, z=38) with inward field orientation. The peak current will not exceed 2 mA. A constant current will be delivered for 20 minutes.

Group V: Sham stimulation Placebo Group 1 Intervention

One of the above three targets will be randomly selected. The current will be applied for 30 seconds ramp-up followed by 30 seconds ramp-down.

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Natural Sciences and Engineering Research Council, Canada

Collaborator

Trials

63

Recruited

3,000+

Findings from Research

High-definition transcranial direct current stimulation (HD-tDCS) is feasible and acceptable for patients with chronic post-stroke aphasia, showing that it can be implemented effectively in a clinical setting with similar protocols to conventional sponge-based tDCS.

Preliminary results indicate that HD-tDCS may improve naming accuracy and response time in patients, with some evidence suggesting it could be more effective than conventional tDCS, although the differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia. Richardson, J., Datta, A., Dmochowski, J., et al.[2023]

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]

The novel high-definition transcranial direct current stimulation (HD-tDCS) setup was found to be safe and well-tolerated, with fewer adverse effects compared to conventional tDCS, based on a study involving 60 healthy participants.

HD-tDCS significantly improved cognitive performance on a visual task, indicating its potential for more effective neural modulation, while also being compatible with simultaneous fMRI without causing significant heating or image quality issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up. Gbadeyan, O., Steinhauser, M., McMahon, K., et al.[2022]

High-Definition transcranial Direct Current Stimulation (HD-tDCS) is a safe and well-tolerated method for non-invasive brain stimulation, even when using a 2 mA current for 22 minutes.

Using a 6% benzocaine topical numbing agent significantly reduces discomfort during HD-tDCS sessions, which can improve the quality of sham-controlled studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced discomfort during high-definition transcutaneous stimulation using 6% benzocaine. Guleyupoglu, B., Febles, N., Minhas, P., et al.[2021]

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 systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

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]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

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]

High-Definition transcranial Direct Current Stimulation (HD-tDCS) significantly increased cortical excitability in the motor cortex, as evidenced by enhanced motor evoked potential (MEP) amplitudes after 20 minutes of stimulation at 1 mA.

The stimulation was well tolerated by participants, with only mild, transient sensations reported, indicating a favorable safety profile for this non-invasive neuromodulatory technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study on effects of 4×1 high-definition tDCS on motor cortex excitability. Caparelli-Daquer, EM., Zimmermann, TJ., Mooshagian, E., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia. [2023]

2. United States 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. [2023]

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

Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Reduced discomfort during high-definition transcutaneous stimulation using 6% benzocaine. [2021]

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

Optimized high-definition tDCS in patients with skull defects and skull plates. [2023]

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

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

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

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

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

Safety of transcranial direct current stimulation in healthy participants. [2021]

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

A pilot study on effects of 4×1 high-definition tDCS on motor cortex excitability. [2022]