Brain Stimulation for Meditation in Healthy Subjects

Overseen By Melanie Boly, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: ADHD stimulants, Antidepressants, Antipsychotics, others

Disqualifiers: Neurological disorders, Bipolar, Psychosis, others

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

Compensation: Varies

Number of Visits: 5

Duration: 3 weeks

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications that may alter seizure threshold, such as certain ADHD stimulants, antidepressants, antipsychotics, bronchodilators, antibiotics, antivirals, and some over-the-counter medications like Diphenhydramine.

What data supports the effectiveness of the treatment Transcranial electrical stimulation (TES) and Transcranial electrical stimulation with temporal interference (TES-TI) for meditation in healthy subjects?

Research shows that meditation can lead to changes in brain activity, such as increased gamma-band oscillations and improved attention, which suggests that brain stimulation techniques like TES and TES-TI might enhance these effects by influencing similar brain networks. ^{1 2 3 4 5}

Is brain stimulation for meditation safe for healthy people?

Research shows that low-intensity transcranial electrical stimulation (TES), including various forms like TES-TI, is generally safe for healthy people. No serious side effects have been reported in thousands of sessions, though mild effects like headaches or skin sensations can occur. Studies also found no significant safety concerns with specific techniques like TI-tACS and tDCS in healthy adults. ^{6 7 8 9 10}

How does Transcranial electrical stimulation with temporal interference (TES-TI) for meditation differ from other treatments?

TES-TI is unique because it uses electrical currents to stimulate specific brain regions, potentially enhancing meditation by altering brain activity patterns. This approach is different from traditional meditation practices, which rely solely on mental training without external stimulation. ^{1 2 11 12 13}

What is the purpose of this trial?

The goal of this clinical trial is to learn whether brain stimulation technology can help people reach a meditative state quickly and easily without years of meditation training. The researchers want to see if this will help people distance themselves from their thoughts and feeling, and if this will lead to improvements in openness and wellbeing the same way meditation can. Participants will: * Complete questionnaires * Perform a guided meditation task (The Bell Task) * Wear a high density electrocochleography (hdEEG) cap * Undergo brain stimulation

Research Team

Melanie Boly, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for healthy individuals interested in participating in a study to explore if brain stimulation can induce a meditative state. Participants will be asked to complete questionnaires, perform meditation tasks, wear an EEG cap, and undergo brain stimulation.

Inclusion Criteria

English-speaking (able to provide consent and complete questionnaires)

I am in good health.

Healthy adults who are meditation-naïve

Exclusion Criteria

Substance abuse or dependence within the past six months

Any current or past history of psychosis

Claustrophobia (a fear of small or closed places)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo TES or TES-TI stimulation in 5-minute blocks up to eight times a day on three separate days each separated by one week

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in ego-disengagement and cortical activity

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Transcranial electrical stimulation (TES)
• Transcranial electrical stimulation with temporal interference (TES-TI)

Trial Overview The NEURO-EGO Study Stage 2 is testing two types of transcranial electrical stimulation (TES and TES-TI) to see if they can help people quickly achieve a state similar to meditation without extensive training.

Participant Groups

Group I: Stimulation Experimental Treatment 2 Interventions

Participants will undergo TES or TES-TI stimulation in 5-minute blocks up to eight times a day on three separate days each separated by one week.

Group II: Sham stimulation Placebo Group 2 Interventions

Participants will undergo sham stimulation in 5-minute blocks up to eight times a day on three separate days each separated by one week.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Tiny Blue Dot Foundation

Collaborator

Trials

9

Recruited

640+

Tiny Blue Dot Foundation

Collaborator

Trials

10

Recruited

660+

Findings from Research

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]

The study assessed the safety of 1.5-mA transcranial direct current stimulation (tDCS) on 49 fasting healthy individuals during Ramadan, finding no serious adverse events or discomfort during the sessions.

There was no significant difference in side effects between active tDCS and sham stimulation, indicating that the tDCS protocol used is safe for fasting adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation of Frontal, Parietal, and Cerebellar Regions in Fasting Healthy Adults. Almousa, A., Alajaji, R., Alaboudi, M., et al.[2020]

In a study involving 38 healthy adults, temporal interference transcranial alternating current stimulation (TI-tACS) was found to be safe, with no significant adverse effects reported after active stimulation at 2 mA for 30 minutes.

The study showed no significant differences in neurological and neuropsychological measurements between the active TI-tACS group and the sham group, indicating that TI-tACS does not negatively impact brain function under the tested conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Evaluation of Employing Temporal Interference Transcranial Alternating Current Stimulation in Human Studies. Piao, Y., Ma, R., Weng, Y., et al.[2022]

References

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

Meditation (Vipassana) and the P3a event-related brain potential. [2018]

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

Long-term meditators self-induce high-amplitude gamma synchrony during mental practice. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Common and distinct lateralised patterns of neural coupling during focused attention, open monitoring and loving kindness meditation. [2021]

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

Reconfiguration of Electroencephalography Microstate Networks after Breath-Focused, Digital Meditation Training. [2022]

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

Acoustic prepulse inhibition: one ear is better than two, but why and when? [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation of Frontal, Parietal, and Cerebellar Regions in Fasting Healthy Adults. [2020]

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

Effects of cranial electrotherapy stimulation on resting state brain activity. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Safety Evaluation of Employing Temporal Interference Transcranial Alternating Current Stimulation in Human Studies. [2022]

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

Neural correlates of focused attention and cognitive monitoring in meditation. [2022]

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

Electrocortical activity prior to unpredictable stimuli in meditators and nonmeditators. [2011]

13. England pubmed.ncbi.nlm.nih.gov

The effect of meditation on brain structure: cortical thickness mapping and diffusion tensor imaging. [2022]