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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether brain stimulation can help people meditate more easily, without years of practice. Researchers aim to determine if this technology can enhance thought and emotion management, boosting openness and well-being, similar to traditional meditation. Participants will try two types of brain stimulation: transcranial electrical stimulation (TES) and transcranial electrical stimulation with temporal interference (TES-TI), along with a placebo version for comparison. The trial seeks healthy adults who have not practiced meditation before. As an unphased trial, this study offers a unique opportunity to explore innovative meditation techniques and contribute to groundbreaking research.

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 prior data suggests that this brain stimulation technology is safe for meditation?

Research has shown that transcranial electrical stimulation (TES) is generally safe and well-tolerated. Studies have found that using TES at low intensity doesn't cause major side effects. Some people might feel mild sensations like tingling or itching, but these are temporary and not harmful.

Safety checks for transcranial electrical stimulation with temporal interference (TES-TI) also suggest it is safe and manageable. Research indicates that TES-TI does not cause serious brain or mental health issues. Some users might feel minor tingling, similar to regular TES, but these effects are usually mild.

Both TES and TES-TI have demonstrated positive safety results in studies, making them promising options for further research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial electrical stimulation (TES) and TES with temporal interference (TES-TI) because they offer a novel approach to enhancing meditation experiences. Unlike traditional meditation techniques, which rely solely on mental practice, TES and TES-TI use electrical currents to directly influence brain activity, potentially leading to deeper and more effective meditative states. TES-TI, in particular, is unique because it allows for targeted stimulation of deeper brain regions without impacting surrounding areas, which could enhance its effectiveness and reduce side effects. These innovations could transform how people experience meditation, making it more accessible and impactful.

What evidence suggests that this trial's treatments could be effective for achieving a meditative state?

Research has shown that transcranial electrical stimulation (TES), a treatment in this trial, can enhance aspects of daily life, such as mental and emotional well-being, especially when combined with meditation. Studies have found that TES can boost cognitive function, aiding thinking and memory. Another treatment in this trial, transcranial electrical stimulation with temporal interference (TES-TI), has shown positive effects on thinking skills and reducing mental fatigue. These brain stimulation methods may enhance meditation by improving focus and promoting relaxation. ^{1 2 4 6 7}

Who Is on the Research Team?

Melanie Boly, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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)

Healthy adults who are meditation-naïve

I am in good health.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1697260023000054

Stimulated brains and meditative minds: A systematic ... Pairing anodal tDCS with meditation shows promising improvements of the physical, mental, and emotional aspects of daily life.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12126258/

Transcranial Direct Current Stimulation and Mindfulness for ... Results: The tDCS group showed significant improvement in cognitive function, with ACE-III scores increasing by 9.14 ± 8.24 points (p = 0.02). Fluency and ...

3. nature.com nature.com/articles/s41598-021-02177-3

Mindfulness augmentation for anxiety through concurrent ... Transcranial direct current stimulation (tDCS) have revealed the capability to augment various types of behavioural interventions.

4. brieflands.com brieflands.com/journals/ijhrba/articles/100909

The Effects of Combined Transcranial Direct Current ... The findings of the present study confirm the effectiveness of the combined approach of mindfulness therapy with electrical stimulation in substance use groups.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835422

Transcranial Electrical Stimulation in Treatment of ... Transcranial direct current stimulation and transcranial alternating current stimulation was associated with positive outcomes among patients with MDD and DPC ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02790619

A Pilot Study Investigating Transcranial Direct Current ... The investigators will be investigating the use of tDCS to augment mindfulness meditation in a double-blind, crossover, randomized, sham-controlled trial.

7. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1501209/full

Transcutaneous and transcranial electrical stimulation for ... This systematic review updates previous findings by examining studies published between 2019 and 2024 that investigated electrical stimulation effects on ...