tDCS for Chronic Pain

(tDCS-pain Trial)

Recruiting at 3 trial locations

Overseen By Guillaume Léonard, Ph. D

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must not be taking: GABAergic, Glutamatergic

Disqualifiers: Contraindications to tDCS, TMS, IRM, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 1 week

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called transcranial direct current stimulation (tDCS) to determine its effectiveness in reducing chronic musculoskeletal pain. Participants will receive either the actual tDCS treatment or a placebo version, which feels similar but doesn't deliver the full treatment. The researchers aim to discover if the real tDCS more effectively lowers pain levels. The trial seeks seniors aged 65 and older who have experienced moderate to severe chronic pain for over six months. As an unphased trial, it offers participants a unique opportunity to contribute to groundbreaking research that could lead to new pain management solutions.

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

If you are taking medications that affect the GABAergic and glutamatergic systems, you cannot participate in the trial. For other medications, you can continue taking them, but you should avoid changing your treatment or dosage during the study unless necessary.

What prior data suggests that this tDCS is safe for reducing chronic pain?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. In past studies, tDCS did not cause any serious side effects. Some participants in the active group reported minor issues like itching. Another study found that the most common side effect was a tingling sensation at the application site.

Overall, these findings suggest that tDCS is well-tolerated, with most people not experiencing severe side effects. This is encouraging for those considering participation in a clinical trial using tDCS for chronic pain relief. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for chronic pain because it offers a non-invasive alternative to traditional treatments like medication. Unlike standard pain relief options that often involve drugs with potential side effects, tDCS uses a gentle electrical current applied to the scalp, which may modulate brain activity and reduce pain perception. This method is particularly promising as it could provide pain relief without the risks associated with long-term medication use. Additionally, tDCS sessions are relatively quick, potentially offering a faster onset of relief compared to some other therapies.

What evidence suggests that transcranial direct current stimulation (tDCS) might be an effective treatment for chronic pain?

Research has shown that transcranial direct current stimulation (tDCS) might help reduce chronic pain. In this trial, participants will receive either actual tDCS or placebo tDCS. Studies have found that tDCS can significantly relieve pain, with effects lasting up to a month after treatment. It has been helpful for conditions like fibromyalgia, migraines, and pain from spinal cord injuries. Some research also suggests it can improve mood and reduce anxiety symptoms related to chronic pain. These findings indicate that tDCS may offer short-term relief for people dealing with chronic pain. ^{1 4 5 6 7}

Who Is on the Research Team?

Guillume Léonard

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

This trial is for seniors aged 65 or older with chronic musculoskeletal pain lasting over 6 months and rated at least moderate in severity. It's not suitable for those with conditions that make tDCS unsafe, like certain contraindications to tDCS, TMS, IRM, or if a health professional thinks the study might harm them. People on medications affecting GABAergic and glutamatergic systems are also excluded.

Inclusion Criteria

I am 65 years old or older.

I have had pain in my muscles or bones for over 6 months, rated at least 4 out of 10.

Exclusion Criteria

You have conditions that make it unsafe for you to receive TMS treatment.

I have epilepsy or seizures but can still participate in the study.

Individuals for whom the procedure could cause impairment of well-being, or has another medical condition that could put them at risk in the judgment of a health care professional

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily 20-minute sessions of tDCS for 5 consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview

The study tests whether actual transcranial direct current stimulation (tDCS) can reduce chronic pain in older adults compared to a placebo version of the same treatment. Participants will be randomly assigned to receive either real or sham tDCS daily for five days and followed up after one week and three months.

How Is the Trial Designed?

Group I: actual tDCS Experimental Treatment 1 Intervention

The actual transcranial direct current stimulation (tDCS) intervention will be conducted by a physiotherapist who will perform 5 sessions of actual tDCS , 5 consecutive days, for 20 minutes of treatment for a total of 45 minutes at the clinic for each session. The tDCS current will be 2 mA for the whole 20-minute session.

Group II: placebo tDCS Placebo Group 1 Intervention

The placebo transcranial direct current stimulation (tDCS) intervention will be conducted by a physiotherapist who will perform 5 sessions of placebo tDCS, 5 consecutive days, for 20 minutes of treatment for a total of 45 minutes at the clinic for each session. The tDCS current will be 2 mA for 30 secondes, and then will strop for the rest of the 20-minute session (programming of the equipment).

Transcranial Direct Current Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Depression
• Anxiety

Approved in European Union as Transcranial Direct Current Stimulation for:

• Chronic pain management
• Neurological rehabilitation

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Five consecutive days of anodal transcranial direct current stimulation (tDCS) over the primary motor cortex significantly improved pain ratings in patients with chronic pain, with effects lasting three to four weeks post-treatment.

The study showed that anodal tDCS decreased intracortical inhibition, indicating enhanced cortical excitability, and no severe adverse effects were reported, suggesting it is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. Antal, A., Terney, D., Kühnl, S., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) is a non-invasive technique that can potentially reduce chronic pain by altering brain activity, but the evidence from five randomized controlled trials is not conclusive.

While some studies reported significant pain reduction with tDCS, the overall results varied widely among different patient groups, indicating a need for further research with larger, more defined populations before tDCS can be recommended as a treatment for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation for chronic pain]. Fagerlund, AJ., Bystad, MK., Aslaksen, PM.[2019]

Transcranial direct-current stimulation (tDCS) significantly reduced both mechanical and thermal hyperalgesia in a rat model of orofacial inflammatory pain, showing effectiveness in pain management up to 7 days post-treatment.

The treatment with tDCS led to increased levels of neurotrophic factors (BDNF and NGF) and anti-inflammatory cytokines (IL-6 and IL-10) in the brainstem, suggesting a mechanism of action that involves modulation of neuroplasticity and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct-current stimulation reduces nociceptive behaviour in an orofacial pain model. Scarabelot, VL., de Oliveira, C., Medeiros, LF., et al.[2019]

Anodal transcranial direct current stimulation (a-tDCS) applied to the primary motor cortex significantly increases sensory and pain thresholds in healthy individuals, with effect sizes of 22.19% and 19.28%, respectively.

In patients with chronic pain, a-tDCS applied to the primary motor cortex and dorsolateral prefrontal cortex resulted in a significant reduction in pain levels, with an average decrease in pain scores of 14.9% and 19.3%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does anodal transcranial direct current stimulation modulate sensory perception and pain? A meta-analysis study. Vaseghi, B., Zoghi, M., Jaberzadeh, S.[2022]

In a study involving 80 healthy participants, high-definition transcranial direct current stimulation (HD-tDCS) did not significantly reduce pain intensity from nerve growth factor-induced pain, indicating limited efficacy in acute pain relief.

However, HD-tDCS was effective in reducing the facilitation of temporal summation of pain in participants experiencing induced pain, suggesting that its benefits may be more pronounced in individuals with sensitized central pain mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of central pain mechanisms using high-definition transcranial direct current stimulation: A double-blind, sham-controlled study. Kold, S., Graven-Nielsen, T.[2023]

Transcranial direct current stimulation (tDCS) is a promising and safe noninvasive technique for managing chronic pain, with effective results observed when targeting the primary motor cortex and prefrontal cortex.

Future strategies to enhance tDCS effects include high-intensity stimulation, transcutaneous spinal stimulation, and home-based devices, which aim to improve accessibility and potentially increase the neuroplastic benefits of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods and strategies of tDCS for the treatment of pain: current status and future directions. Pacheco-Barrios, K., Cardenas-Rojas, A., Thibaut, A., et al.[2023]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

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]

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) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

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]

Citations

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pmc.ncbi.nlm.nih.gov

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Our findings suggest that tDCS might be effective for fibromyalgia, migraine, and neuropathic pain associated with spinal cord injury and stroke ...

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This study found significant treatment effects across time for clinical pain and for fatigue, cognitive and sleep disturbances, and experimental ...

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sciencedirect.com

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Our results showed significant pain relief immediately after the end of the treatment and this effect lasted for 1 month after stopping stimulation. Regarding ...

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frontiersin.org/journals/molecular-neuroscience/articles/10.3389/fnmol.2022.1056966/full

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Conclusion: tDCS may be an effective short-term treatment for the improvement of pain intensity and concomitant depression and anxiety symptoms in chronic pain ...

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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.

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sciencedirect.com

sciencedirect.com/science/article/pii/S2405650224000054

“Transcranial direct current stimulation for chronic foot pain ...

The findings indicate that tDCS holds promise for managing chronic foot pain, including plantar fasciitis. Main results suggest significant reductions in pain ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39825590/

The safety and feasibility of transcranial direct current ...

Transcranial direct current stimulation was safe, with no serious adverse events and one minor adverse event in the active group. Itching was a ...