Transcranial Direct Current Stimulation for Pain

(StimMAP Trial)

Overseen By Tor Wager D Principal Investigator, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Trustees of Dartmouth College

Must not be taking: CNS medications

Disqualifiers: Depression, Seizure disorder, Stroke, others

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

Compensation: Varies

Number of Visits: 5

Duration: 3 sessions over 3 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a brain stimulation technique, transcranial direct current stimulation (tDCS), affects pain perception and response. Researchers aim to determine if different types of tDCS can alter pain perception and decision-making in social contexts. Participants will experience various tDCS setups in separate sessions. This trial may suit individuals fluent in English, without a history of mental health or neurological conditions, and who have not experienced chronic or recent acute pain. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on pain management techniques.

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 to participate in this trial.

What prior data suggests that transcranial direct current stimulation is safe for pain management?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. Studies indicate that tDCS can reduce pain and is well-tolerated by many patients. Some mild side effects, such as tingling or itching under the electrodes, headache, or fatigue, have been reported, but these are usually not serious.

Other studies have found that tDCS remains safe when combined with treatments like exercise. It has even helped lessen the effects of conditions such as chronic pain and depression. Overall, based on past research, tDCS is considered a low-risk treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for pain management because it offers a non-invasive and drug-free approach. Unlike traditional pain treatments that often rely on medications with potential side effects, tDCS uses a mild electrical current to modulate brain activity, potentially reducing pain perception. Additionally, the technique is versatile, allowing for targeted stimulation of specific brain areas, which could lead to more personalized and effective pain management strategies. This innovative approach could provide relief for individuals who have not responded well to conventional treatments.

What evidence suggests that transcranial direct current stimulation is effective for pain?

Research has shown that transcranial direct current stimulation (tDCS) can help reduce pain. Studies have found that it eases the handling of hot and cold sensations. Some research suggests that the pain relief from tDCS can last up to a month after treatment ends. This non-invasive method has also shown promise for conditions like fibromyalgia, helping manage pain and reduce symptoms. Overall, tDCS is being explored as a possible alternative to pain medications, such as opioids, for managing chronic pain. In this trial, participants will experience different tDCS interventions—anodal, cathodal, or sham—in a randomized and double-blind fashion to evaluate their effects on pain management. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for up to 50 participants who are interested in how brain stimulation affects pain perception and decision-making. Participants will undergo sessions involving different types of transcranial direct current stimulation (tDCS) while their responses to pain and decisions about money offers are observed.

Inclusion Criteria

Participants must be capable of performing experimental tasks (e.g., are able to read)

I am between 18 and 55 years old.

I am a fluent or native English speaker.

Exclusion Criteria

I haven't had a seizure in the last 10 years.

I do not have frequent headaches (15 or more in a month).

I haven't used psychiatric drugs or abused substances in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 session

1 visit (in-person)

Calibration

Initial pain calibration session to determine individual pain and tolerance levels

1 session

1 visit (in-person)

Treatment

Participants undergo three experimental sessions with anodal, cathodal, or sham tDCS, including pain testing and decision-making tasks

3 sessions over 3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview The study tests the effects of three tDCS protocols on the left primary motor cortex: anodal, which may decrease pain; cathodal, which might increase it; and sham as a control. The impact on thermal pain perception, decision-making related to monetary offers, and placebo effects in social contexts will be assessed inside an MR scanner.

How Is the Trial Designed?

Group I: Within-person Crossover Experimental Treatment 3 Interventions

This within-person crossover study involves a single arm, where each participant experiences an initial pain calibration session, followed by three full study sessions involving anodal, cathodal, or sham tDCS interventions. Only one intervention type (anodal, cathodal, or sham) is applied per session, in a randomized and double-blind fashion.

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/PMC12485468/

Effects of Transcranial Direct Current Stimulation on pain and ... tDCS appears to decrease pain intensity and modulate thresholds for pressure and heat pain, as well as enhance tolerance to heat and cold.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2214751925000556

The effects of transcranial direct current stimulation on ... Our results showed significant pain relief immediately after the end of the treatment and this effect lasted for 1 month after stopping stimulation. Regarding ...

3. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-023-03445-7

The effects of transcranial direct-current stimulation (tDCS) on ... tDCS is a non-invasive brain stimulation technique that has shown promise as a potential treatment for FM by modulating pain perception and reducing symptoms.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10813480/

Efficacy of Transcranial Direct Current Stimulation on Pain ... This study found significant treatment effects across time for clinical pain and for fatigue, cognitive and sleep disturbances, and experimental ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05863494

Transcranial Direct Current Stimulation and Chronic Pain The overarching goal of this project is to apply transcranial direct current stimulation (tDCS) as an alternative to opioids for the reduction in chronic pain.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5577893/

a protocol for a pilot randomised controlled trial A mild tingling or itching sensation under the electrodes, fatigue, headache, nausea and insomnia have been reported as potential adverse ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0987705324000029

Efficacy and safety of transcranial direct current stimulation ... tDCS is a safe intervention that relieves pain intensity, reduces depression, and reduces the impact of FM on life.

8. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14887

The safety and feasibility of transcranial direct current ... We found transcranial direct current stimulation combined with exercise therapy was safe and feasible for patients with cervicogenic headache; ...

9. epain.org epain.org/journal/view.html?uid=1917&vmd=Full

Effects of Transcranial Direct Current Stimulation on pain ... tDCS is a risk-free treatment that may help FM patients experience less severe pain. Cai et al. [22], USA, China, 2021, SR + MA of RCTs ...