Mindfulness + tDCS for Placebo Effect

Overseen By Tor Wager, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Trustees of Dartmouth College

Must not be taking: CNS medications

Disqualifiers: Depression, Bipolar, Seizure, Stroke, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mindfulness and brain stimulation influence feelings like anxiety or sadness. Participants will engage in either mindfulness exercises or placebo brain stimulation (sham tDCS, a type of non-invasive brain stimulation) to assess effects on mood. The trial seeks individuals without recent depression, migraines, or substance abuse issues, and who can tolerate some heat discomfort during the study. This offers a chance to help understand how different treatments might alter negative emotions.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on emotional well-being.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications that affect the central nervous system or are used for neurological or psychiatric treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past studies have shown that transcranial direct current stimulation (tDCS) is safe. Most participants experience only mild side effects, such as a slight tingling on the scalp, which quickly subsides. Importantly, no serious side effects were reported. Research also indicates that combining tDCS with mindfulness practices can enhance thinking skills and emotional well-being without causing harm.

Overall, existing research considers both tDCS and mindfulness safe. Participants in a trial might feel mild sensations during tDCS, but these are typically temporary and not harmful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how combining mindfulness techniques with transcranial direct current stimulation (tDCS) might enhance the placebo effect. Unlike standard treatments that typically rely on medication or therapy alone, this trial examines the potential synergy between a mental practice and brain stimulation. By alternating real and sham tDCS in both mindfulness and no-mindfulness settings, the study aims to uncover how these elements contribute individually and together to perceived improvements. This approach could lead to innovative ways to amplify treatment outcomes without additional medications, providing a unique avenue for enhancing therapeutic effects.

What evidence suggests that this trial's treatments could be effective for reducing negative affect?

This trial will explore the effects of combining mindfulness-based meditation with transcranial direct current stimulation (tDCS). Research has shown that mindfulness-based meditation can enhance cognitive function and emotional regulation, potentially reducing anxiety, especially for those anticipating positive outcomes from the treatment.

For tDCS, evidence suggests it can aid in pain relief and improve cognitive and sleep issues. Some studies found no significant difference between real and sham tDCS, indicating a strong placebo effect. However, important improvements in pain levels and related difficulties have been observed with real tDCS. Participants in this trial will experience various combinations of mindfulness and tDCS, including both real and sham tDCS, to assess these effects. ^{6 7 8 9 10}

Who Is on the Research Team?

Tor Wager, Ph.D.

Principal Investigator

Dartmouth College

Are You a Good Fit for This Trial?

This trial is for individuals experiencing chronic pain, particularly after surgery. Participants should be interested in placebo effects and mindfulness techniques. Specific eligibility criteria are not provided, but typically include being of a certain age range and having the ability to undergo fMRI scanning.

Inclusion Criteria

Participants must be capable of performing experimental tasks (e.g., are able to read), are fluent or native speakers of English

I can handle the highest level of heat pain.

Exclusion Criteria

No self-reported substance abuse within the last six months

No self-reported current or history of depression, bipolar disorder, or other psychiatric diagnosis

I haven't had seizures, strokes, or major neurological issues affecting my thinking in the last 10 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Session 1: Mindfulness/No-mindfulness Induction

Participants undergo either a Mindful State Induction or a No-mindfulness control procedure, including education and hypnotic induction or task-focused instructions.

1 session

1 visit (in-person)

Session 2: Transfer Test with tDCS

Participants undergo a transfer test with verum motor-cortex tDCS in an off-on-off design, assessing spontaneous use of strategies.

1 session, 1 week after Session 1

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the sessions, including assessment of self-report measures and autonomic reactivity.

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Mindful state induction
• No mindfulness induction
• tDCS stimulation (real)
• tDCS stimulation (sham)

Trial Overview The study investigates how believing in treatment without active ingredients (placebo) and being mindfully aware can influence emotions related to pain. It involves comparing real vs sham brain stimulation (tDCS) combined with either mindful state induction or no mindfulness at all while performing tasks under an fMRI scanner.

How Is the Trial Designed?

Group I: no mindfulness (session 1) + sham tdcs, real tdcs (session 2) Experimental Treatment 3 Interventions

Assigned to the no-mindfulness control group in session 1. Will experience sham tdcs, followed by real tdcs for session 2.

Group II: no mindfulness (session 1) + real tdcs, sham tcds (session 2) Experimental Treatment 3 Interventions

Assigned to the no-mindfulness control group in session 1. Will experience real tdcs, followed by sham tdcs for session 2.

Group III: mindfulness (session 1)+ real tdcs, sham tdcs (session 2) Experimental Treatment 3 Interventions

Assigned to the mindfulness group in session 1. Will experience real tdcs, followed by sham tdcs for session 2.

Group IV: mindfulness (session 1) + sham tcds, real tdcs (session 2) Experimental Treatment 3 Interventions

Assigned to the mindfulness group in session 1. Will experience sham tdcs, followed by real tdcs for session 2.

Who Is Running the Clinical Trial?

Trustees of Dartmouth College

Lead Sponsor

Trials

32

Recruited

14,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6597333/

Measuring Cognitive Outcomes in Mindfulness-based ... One potential pathway by which mindfulness-based meditation improves health outcomes is through changes in cognitive functioning.

2. link.springer.com link.springer.com/article/10.1007/s12671-025-02624-6

The Impact of Understanding and Openness on State ... These findings emphasise the benefits of fostering open attitudes to mindfulness-based interventions (MBIs) to maximise treatment outcomes in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S000578942400039X

Mindfulness Effects on Anxiety: Disentangling the Role of ... This indicated that, in the placebo expectation induction group, anxiety was reduced by mindful decentering only in those with high baseline expectations about ...

4. nature.com nature.com/articles/s41599-024-03492-6

Enacting the mind/body connection: the role of self-induced ... Placebo effects are beneficial mind-body outcomes derived from beliefs or expectations, not explainable as the consequence of active medical ...

5. researchgate.net researchgate.net/publication/343347575_Mindfulness_induction_and_cognition_A_systematic_review_and_meta-analysis

Mindfulness induction and cognition: A systematic review ... Mindfulness meditation might improve a variety of cognitive processes, but the available evidence remains fragmented.

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

Transcranial Direct Current Stimulation and Mindfulness for ... This study is aimed at evaluating the efficacy of mindfulness and tDCS in enhancing cognitive function and alleviating depression in stroke survivors.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278262625000478

A systematic review and meta-analysis of self-reported ... The present findings provide evidence from sham RCTs that tDCS combined with mindfulness practice can augment self-reported mindfulness.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1155/srat/3893469

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).

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12538427/

The impact of transcranial direct current stimulation ... Combining virtual reality-focused mindfulness (VR-FM) and transcranial direct current stimulation (tDCS) can enhance cognitive performance, ...

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

The Effects of Combined Transcranial Direct Current ... Negative emotions significantly improved in the combination group receiving real tDCS + MBSAT (PIN-CODES), as compared to baseline values and sham stimulation ...