tDCS for Cerebral Atherosclerosis

Overseen By Amy Headlee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Metallic implants, others

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

Compensation: Varies

Number of Visits: 21

50 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 study team or your doctor.

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe and well-tolerated, with most side effects being mild and temporary, such as tingling or itching. However, there are warnings that it could potentially cause serious conditions, so caution is advised. In studies, most participants reported positive experiences, and adverse events were rare and not directly related to tDCS. ^{1 2 3 4 5}

How is the Soterix® tDCS treatment unique for cerebral atherosclerosis?

The Soterix® tDCS treatment is unique because it uses transcranial direct current stimulation (tDCS), a non-invasive method that applies a mild electrical current to the scalp to potentially improve brain function. Unlike traditional treatments for cerebral atherosclerosis, which may focus on medication or surgery, tDCS aims to enhance brain activity and blood flow without significant discomfort or invasive procedures. ^{6 7 8 9 10}

What is the purpose of this trial?

This study is being done to examine whether transcranial direct current stimulation (tDCS) will increase cerebral blood flow which may provide a clinical benefit such as improving cognitive impairment.

Research Team

Zafer Keser

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with conditions like Moyamoya Syndrome and various forms of cerebral atherosclerosis, which affect blood flow to the brain. Participants should be experiencing cognitive impairment due to these conditions.

Inclusion Criteria

My scans show reduced blood flow due to blood vessel issues.

I have trouble with memory or thinking clearly.

Exclusion Criteria

Pregnancy

Contraindication to MRI or tDCS including metallic implanted objects

Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I - Active and Sham Stimulation

Participants receive 20 minutes of 2 mA tDCS or sham stimulation concurrently with MRI cerebral blood flow imaging, followed by no stimulation and imaging.

1 day

1 visit (in-person)

Phase II - Active and Sham Stimulation with Cognitive Training

Participants receive active or sham tDCS plus cognitive training every weekday for 10 days, followed by a 4-week washout period, then the alternate stimulation for another 10 days.

8 weeks

20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Soterix® 1x1 tDCS
• Soterix® 4x1HD-TDCS

Trial Overview The study tests if using transcranial direct current stimulation (tDCS), specifically Soterix® devices, can boost blood flow in the brain and improve thinking skills affected by chronic hypoperfusion.

Participant Groups

Group I: Phase II Sham Stimulation, Then Active Stimulation Experimental Treatment 2 Interventions

Subjects first receive sham tDCS plus cognitive training daily for 10 days. After a washout period of 4 weeks, they will perform at-home active tDCS plus cognitive training daily for 10 days.

Group II: Phase II Active Stimulation, Then Sham Stimulation Experimental Treatment 2 Interventions

Subjects first receive active tDCS plus cognitive training every weekday for 10 days. After washout period of 4 weeks, they will perform at-home sham tDCS plus cognitive training every weekday for 10 days.

Group III: Phase I Disease Group: Sham Stimulation, Then Active Stimulation Experimental Treatment 1 Intervention

Subject diagnosed with Moyamoya disease or severe extracranial atherosclerotic disease will receive sham stimulation concurrently with MRI CBF imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive 20 minutes of 2 mA tDCS concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.

Group IV: Phase I Disease Group: Active Stimulation, Then Sham Stimulation Experimental Treatment 1 Intervention

Subject diagnosed with Moyamoya disease or severe extracranial atherosclerotic disease will receive 20 minutes of 2 mA tDCS concurrently with MRI cerebral blood flow (CBF) imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive sham stimulation concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.

Group V: Phase I - Health Volunteer Group: Sham Stimulation, Then Active Stimulation Experimental Treatment 1 Intervention

Healthy subjects will receive sham stimulation concurrently with MRI CBF imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive 20 minutes of 2 mA tDCS concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.

Group VI: Phase I - Health Volunteer Group: Active Stimulation, Then Sham Stimulation Experimental Treatment 1 Intervention

Healthy subjects will receive 20 minutes of 2 mA tDCS concurrently with MRI cerebral blood flow (CBF) imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive sham stimulation concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

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]

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]

Transcranial direct current stimulation (tDCS) was found to be feasible and safe for use in outpatient therapy for stroke patients, with 100% adherence among the 7 participants who completed the study over 5-6 weeks.

Most participants (71%) reported positive impressions of tDCS, experiencing acute improvements in function and energy, with only one adverse event unrelated to the treatment and mild side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. Cleland, BT., Galick, M., Huckstep, A., et al.[2020]

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 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]

In a study of 32 stroke inpatients, those who received bihemispheric transcranial direct current stimulation (tDCS) alongside physical and occupational therapy showed significantly greater improvements in upper extremity motor function compared to those who received sham tDCS.

The most notable benefits were observed in chronic stroke patients (over 6 months post-stroke), indicating that tDCS may be particularly effective for this group in enhancing their functional independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. Alisar, DC., Ozen, S., Sozay, S.[2020]

In a pilot study involving 91 subacute stroke patients, those receiving cathodal tDCS combined with conventional rehabilitation showed significant improvements in lower limb motor function compared to the control group, with notable results at both immediate post-treatment and one-month follow-up assessments.

While the results indicate that cathodal tDCS may enhance recovery of motor function, the overall effectiveness remains inconclusive, suggesting the need for larger randomized controlled trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Cathodal Transcranial Direct Current Stimulation for Lower Limb Subacute Stroke Rehabilitation. Duan, Q., Liu, W., Yang, J., et al.[2023]

In a study involving 19 stroke survivors, transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex did not significantly increase the number of completed rehabilitation therapy sessions compared to sham treatment.

Despite being well tolerated, tDCS did not show an effect on participation in rehabilitation, indicating that it may not be an effective intervention for enhancing therapy session completion in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation to Optimise Participation in Stroke Rehabilitation - A Sham-Controlled Cross-Over Feasibility Study. Etherton-Beer, C., Lui, Y., Radalj, M., et al.[2022]

References

1. 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]

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

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

3. 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]

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

Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. [2020]

5. England pubmed.ncbi.nlm.nih.gov

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

6. 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]

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

Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Middle cerebral artery blood flow stability in response to high-definition transcranial electrical stimulation: A randomized sham-controlled clinical trial. [2022]

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

Effect of Cathodal Transcranial Direct Current Stimulation for Lower Limb Subacute Stroke Rehabilitation. [2023]

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

Transcranial Direct Current Stimulation to Optimise Participation in Stroke Rehabilitation - A Sham-Controlled Cross-Over Feasibility Study. [2022]