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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how High Definition Transcranial Direct Current Stimulation (HD-tDCS) affects the brain. HD-tDCS uses a gentle electric current to potentially improve brain function. The study includes four groups receiving stimulation in different brain areas and one group receiving a sham treatment for comparison. It suits individuals without a history of neurological or psychiatric issues and those who are not pregnant or breastfeeding. The goal is to improve understanding of this treatment to enhance its benefits.

As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to significant advancements in brain health.

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 prior data suggests that HD-tDCS is safe for use in this study?

Research has shown that High Definition Transcranial Direct Current Stimulation (HD-tDCS) is generally safe. Studies indicate that HD-tDCS is well-tolerated, even at higher levels, such as 3 mA, which exceeds the 2 mA used in this trial. Most participants do not experience serious side effects, with skin irritation being the most common minor issue. Importantly, previous studies have reported no severe adverse effects. This evidence suggests that HD-tDCS is 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 HD-tDCS for electrocution because it offers a non-invasive and targeted approach to brain stimulation. Unlike traditional treatments that might rely on medications, HD-tDCS uses direct current delivered through electrodes placed on the scalp. This method allows for precise targeting of specific brain regions, such as the ventrolateral prefrontal cortex and dorsolateral prefrontal cortex, potentially reducing unwanted side effects. Moreover, the ability to simulate and adjust the current flow using computer software means a personalized approach for each patient, which could lead to more effective outcomes.

What evidence suggests that this trial's treatments could be effective for electrocution?

This trial will evaluate the effects of high-definition transcranial direct current stimulation (HD-tDCS) on brain function. Research has shown that HD-tDCS might improve brain function, with studies finding it can boost memory and mood in people with depression. It has also enhanced motor skills in both healthy individuals and those with movement difficulties. This treatment uses a small electric current to stimulate specific brain areas, potentially leading to better mental and physical performance. Overall, early evidence suggests that HD-tDCS could be a promising method for improving brain and motor functions. Participants in this trial will be assigned to different treatment arms, including various HD-tDCS stimulation targets and a sham stimulation group. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X22002364

A systematic review and meta-analysis of healthy adults This systematic review analyzed the current literature on anodal HD-tDCS for WM enhancement, investigating its effectiveness and the influence of different ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37660936/

Tolerability and blinding of high-definition transcranial direct ... HD-tDCS was well tolerated with mostly no ("none") or "mild" sensations reported across sessions, regardless of active or sham condition and in ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838763

Personalized High-Definition Transcranial Direct Current ... In this randomized clinical trial, mood in participants with moderate to severe depression significantly improved after 12 days of left DLPFC ...

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00899-z

The effect of high-definition transcranial direct current ... tDCS has been shown in some studies to be an effective means to improve motor performance in healthy subjects as well as patients suffering from ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06241963

High Definition Transcranial Direct Current Stimulation (HD ... All participants underwent a medical evaluation that included physical examination and routine laboratory studies before and after high definition ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X18301475

Tolerability and blinding of 4x1 high-definition transcranial ... HD-tDCS appears well-tolerated and safe with effective sham-control in older adults, even at 3 mA. These data support the use of HD-tDCS in randomized ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6123849/

Adverse events of tDCS and tACS: A review - PubMed Central No serious adverse effects have been reported in experiments using either tDCS or tACS. Persistent adverse effects of tDCS are mainly skin problems; for tACS, ...