Brain Stimulation and Meditation for Emotional Regulation

Overseen By Isa Dolski

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Antidepressants, Antipsychotics, Antibiotics, others

Disqualifiers: Mental health, Neurological disorders, Pregnancy, others

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

Compensation: Varies

Number of Visits: 8

96 Participants Needed

Trial Summary

What is the purpose of this trial?

This study uses two different types of interventions including electrical brain stimulation delivered during sleep, and brief, daily meditation training. The investigators are trying to figure out whether these techniques, either alone or in combination with each other, can positively impact the brain networks that support our ability to think flexibly and to regulate our emotions. 48 participants will be enrolled into each of 2 phases and can expect to be on study for up to 9 months.

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

Yes, you may need to stop taking certain medications. The trial excludes participants who have taken medications for mental illness in the past 6 months and those on medications that may alter seizure thresholds, such as ADHD stimulants, certain antidepressants, antipsychotics, bronchodilators, some antibiotics, antivirals, and over-the-counter drugs like diphenhydramine (Benadryl).

Will I have to stop taking my current medications?

The trial requires that participants do not take certain medications that may affect seizure risk, such as ADHD stimulants, certain antidepressants, antipsychotics, bronchodilators, some antibiotics, antivirals, and some over-the-counter medications like Benadryl. If you are on any of these, you may need to stop taking them to participate.

What data supports the idea that Brain Stimulation and Meditation for Emotional Regulation is an effective treatment?

The available research shows that meditation can improve self-regulation, which is the ability to control emotions and attention, in people of different ages. Studies have found that even short-term meditation practice can lead to positive changes in the brain areas related to self-regulation. Additionally, combining mindfulness-based training with brain stimulation techniques like transcranial direct current stimulation (tDCS) has shown promise in enhancing cognitive abilities, such as working memory and attention. Mindfulness-based stress reduction (MBSR) has also been effective in reducing psychological distress and improving emotional regulation. These findings suggest that Brain Stimulation and Meditation for Emotional Regulation can be effective in improving emotional control and overall well-being. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Brain Stimulation and Meditation for Emotional Regulation?

Research shows that meditation can improve self-regulation and emotional control, while mindfulness-based training combined with brain stimulation like tDCS can enhance cognitive abilities such as working memory. Additionally, mindfulness-based stress reduction has been found to reduce psychological distress and improve emotional regulation. ^{1 2 3 4 5}

What safety data exists for brain stimulation and meditation treatments?

The safety data for brain stimulation techniques like tDCS and tACS suggest that they are generally safe with mild and transient adverse effects such as itching, tingling, headache, and burning sensations. Serious adverse events are rare, with some reports of skin burns and rare cases of mania or hypomania in patients with depression. There is a need for more systematic reporting and assessment of adverse events to improve safety guidelines. Meditation techniques like mindfulness meditation are generally considered safe, but specific safety data for combined treatments with brain stimulation is limited. ^{6 7 8 9 10}

Is brain stimulation and meditation safe for humans?

Brain stimulation techniques like transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) are generally considered safe, with most side effects being mild and temporary, such as itching, tingling, or headaches. Serious side effects are rare, but there have been isolated reports of skin burns and mood changes in some individuals. Overall, these methods have been used safely in many sessions with both healthy individuals and patients. ^{6 7 8 9 10}

Is the treatment of brain stimulation and meditation for emotional regulation promising?

Yes, brain stimulation and meditation are promising treatments for emotional regulation. Meditation helps improve self-control and emotional balance by enhancing brain activity related to attention and emotion. It can also increase awareness of bodily and emotional states, which helps in managing negative emotions. Meditation is like mental exercise that strengthens the brain's ability to handle stress and emotions, making it a cost-effective way to improve mood and emotional health. ^{1 11 12 13 14}

How does the treatment of brain stimulation and meditation for emotional regulation differ from other treatments?

This treatment is unique because it combines brain stimulation techniques, like tDCS and TMS, with meditation practices to enhance emotional regulation. Unlike traditional treatments that may focus solely on medication or therapy, this approach uses electrical stimulation to directly influence brain activity and meditation to improve self-regulation and emotional balance. ^{1 11 12 13 14}

Research Team

Richard Davidson, PhD

Principal Investigator

University of Wisconsin, Madison

Giulio Tononi, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

The Neuro Optimize Study is for individuals interested in improving cognitive flexibility and emotional regulation. Participants should be willing to undergo brain stimulation during sleep, daily meditation training, and MRI scans over a period of up to 9 months.

Inclusion Criteria

I am in good health.

Citizen or legal resident

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

Exclusion Criteria

I have been diagnosed with sleep apnea or another sleep disorder.

I am not taking any medications that can affect seizure risk.

I can lie flat without back pain for up to two hours.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including self-report measures, behavioral tasks, MRI, and a sleep study

1 week

Intervention

Participants receive meditation and/or TES-TI interventions for 4 weeks, with 2 nights per week in the sleep lab

4 weeks

8 visits (in-person)

Post-Intervention Assessment

Participants repeat assessments including behavioral, self-report, and imaging measures

1 week

Follow-up

Participants complete follow-up assessments including self-report and behavioral measures at 4 months post-intervention

16 weeks

Treatment Details

Interventions

• Electrical Brain Stimulation
• Meditation Training

Trial Overview This study tests the effects of electrical brain stimulation and meditation on thinking flexibility and emotion control. It involves two interventions: one with actual stimulation during sleep, another with daily meditation lessons. The impact will be measured using MRI scans.

Participant Groups

Group I: Group 4: Combined, High Frequency (Phase 1 and Phase 2) Experimental Treatment 3 Interventions

* Baseline measures including imaging * Meditation plus Stimulation in Lab 2 nights per week for 4 weeks * Post Intervention (week 5) measures including imaging * Follow up measures (week 20)

Group II: Group 3: Combined, Low Frequency (Phase 1) Experimental Treatment 3 Interventions

* Baseline measures including imaging * Meditation plus Stimulation in Lab 1 night per week for 4 weeks * Post Intervention (week 5) measures including imaging * Follow up measures (week 20)

Group III: Group 2: Stimulation Only (Phase 1 and Phase 2) Experimental Treatment 3 Interventions

* Baseline measures including imaging * Sham Meditation plus Stimulation in Lab 2 nights per week for 4 weeks * Post Intervention (week 5) measures including imaging * Follow up measures (week 20)

Group IV: Group 1: Mediation Only (Phase 1 and Phase 2) Experimental Treatment 3 Interventions

* Baseline measures including imaging * Meditation plus Sham Stimulation 2 nights per week for 4 weeks * Post Intervention (week 5) measures including imaging * Follow up measures (week 20)

Electrical Brain Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Electrical Brain Stimulation for:

• Depression
• Anxiety
• Chronic Pain
• Stroke Rehabilitation

Approved in European Union as Electrical Brain Stimulation for:

• Major Depressive Disorder
• Chronic Pain
• Stroke Rehabilitation

Approved in Canada as Electrical Brain Stimulation for:

• Depression
• Chronic Pain
• Stroke Rehabilitation

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

Meditation can significantly enhance emotion and attention regulation, with studies showing positive effects in various age groups, including undergraduates and children, after just 5 days of practice.

Neuroimaging studies indicate that meditation improves brain activation and connectivity in areas associated with self-regulation, suggesting its potential for helping with mental disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation improves self-regulation over the life span. Tang, YY., Posner, MI., Rothbart, MK.[2021]

A study involving 34 healthy participants showed that combining mindfulness-based training (MBT) with transcranial electrical stimulation (tDCS) improved working memory performance, particularly on challenging tasks like the 3-back test.

Neurophysiological measurements indicated that this combined approach (eMBT) led to changes in brain activity patterns, suggesting that eMBT may enhance cognitive capacity by promoting more efficient brain resource allocation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based training with transcranial direct current stimulation modulates neuronal resource allocation in working memory: A randomized pilot study with a nonequivalent control group. Hunter, MA., Lieberman, G., Coffman, BA., et al.[2020]

Mindfulness-based stress reduction (MBSR) significantly improved emotional regulation in adults, leading to increased mindfulness and self-compassion, and decreased emotional suppression and aggression, based on a study of 56 participants over 8 weeks.

Participants who completed MBSR showed lasting benefits, including reduced rumination and improved emotional responses, which were maintained even 2 months after the program ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based stress reduction on emotional experience and expression: a randomized controlled trial. Robins, CJ., Keng, SL., Ekblad, AG., et al.[2015]

In a study of 32 patients undergoing rTMS for major depressive episodes, significant reductions in depression and anxiety scores were observed, indicating the treatment's efficacy in improving mental health.

The study also found that rTMS was associated with improvements in mindfulness components, specifically nonreactivity to inner experiences and decentring, suggesting that rTMS may enhance mindfulness independently of its effects on depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in mindfulness following repetitive transcranial magnetic stimulation for mood disorders. Leong, K., Chan, P., Grabovac, A., et al.[2017]

An 8-week mindfulness-based stress reduction (MBSR) program significantly improved pain perception, quality of life, coping with pain, anxiety, and depression in 58 female fibromyalgia patients, with effect sizes ranging from 0.40 to 1.10.

A 3-year follow-up of 26 participants showed that the benefits of MBSR were sustained over time, with effect sizes between 0.50 and 0.65, indicating its potential for long-term positive impact on well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training as an intervention for fibromyalgia: evidence of postintervention and 3-year follow-up benefits in well-being. Grossman, P., Tiefenthaler-Gilmer, U., Raysz, A., et al.[2019]

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) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

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 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]

Transcranial direct current stimulation (tDCS) is generally considered safe, with most adverse effects being mild and temporary; however, some cases of persistent skin lesions and rare instances of mania or hypomania have been reported, particularly in patients with depression.

Transcranial alternating current stimulation (tACS) has fewer reported adverse events, and no persistent effects have been documented, but more research is needed to fully establish its safety compared to tDCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of tDCS and tACS: A review. Matsumoto, H., Ugawa, Y.[2020]

Meditation appears to enhance cognitive control and emotional regulation, as indicated by increased prefrontal/frontal brain activity in both naive and long-term meditators when responding to negative emotional stimuli.

Additionally, meditation may promote greater bodily awareness, as suggested by increased insular activity in meditators, highlighting its potential role in improving interoceptive awareness of emotions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Meditation Alter Brain Responses to Negative Stimuli? A Systematic Review. Magalhaes, AA., Oliveira, L., Pereira, MG., et al.[2020]

Meditation practices, particularly focused attention and open monitoring styles, are designed to enhance emotional regulation and attention, which can lead to improved well-being and emotional balance.

These meditation styles may have lasting effects on brain function and behavior, suggesting their potential as effective tools for mental health and emotional management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention regulation and monitoring in meditation. Lutz, A., Slagter, HA., Dunne, JD., et al.[2022]

Long-term meditation practice can enhance cognitive control and affective regulation by inducing neuroplastic changes in the brain, suggesting it may serve as an effective intervention for mood disorders.

Research indicates that mindfulness meditation, which promotes awareness and acceptance, can improve affective regulation and is increasingly being integrated into traditional psychotherapeutic treatments, showing promising results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential therapeutic effects of meditation for treating affective dysregulation. Leung, NT., Lo, MM., Lee, TM.[2021]

A meta-analysis of 10 neuroimaging studies involving 91 subjects identified a core network in the brain that is activated during various meditation techniques, suggesting a shared central process across different forms of meditation.

Key brain regions involved in meditation include the basal ganglia, limbic system, and medial prefrontal cortex, which play important roles in relaxation, attention regulation, and detachment from thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A neurocognitive model of meditation based on activation likelihood estimation (ALE) meta-analysis. Sperduti, M., Martinelli, P., Piolino, P.[2016]

References

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

Meditation improves self-regulation over the life span. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based training with transcranial direct current stimulation modulates neuronal resource allocation in working memory: A randomized pilot study with a nonequivalent control group. [2020]

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

Effects of mindfulness-based stress reduction on emotional experience and expression: a randomized controlled trial. [2015]

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

Changes in mindfulness following repetitive transcranial magnetic stimulation for mood disorders. [2017]

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

Mindfulness training as an intervention for fibromyalgia: evidence of postintervention and 3-year follow-up benefits in well-being. [2019]

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

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]

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

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

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

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

10. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events of tDCS and tACS: A review. [2020]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Does Meditation Alter Brain Responses to Negative Stimuli? A Systematic Review. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Attention regulation and monitoring in meditation. [2022]

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

Potential therapeutic effects of meditation for treating affective dysregulation. [2021]

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

A neurocognitive model of meditation based on activation likelihood estimation (ALE) meta-analysis. [2016]