tDCS for Chronic Pain

(tDCS-pain Trial)

Recruiting at 2 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?

The primary objective of this study is to determine, in a healthcare setting, the effectiveness of actual tDCS in reducing pain compared with placebo tDCS. This is a multicenter randomized controlled trial with parallel groups (real tDCS vs. placebo) blinded to participants, assessors and tDCS providers. The real tDCS group will receive a daily 20-minute session of tDCS (current intensity = 2 mA), for 5 consecutive days, while the placebo tDCS group will receive an equivalent treatment, but the current will be stopped after the first 30 seconds. The study will take place in 5 rehabilitation clinics in 3 Quebec regions. One hundred and fifty (150) seniors aged 65 years or older with chronic (\> 6 months), moderate to severe musculoskeletal pain will be recruited (50 participants/region). Follow-ups will take place at 1 week and 3 months post-treatment. The primary dependent variable is pain intensity (numerical scale from 0 to 10). Secondary variables will be measured using standardized and validated questionnaires: 1) pain-related interferences (physical function, mood, quality of life) and 2) perception of post-TDCS changes. Neurophysiological measures (pain control pathways).

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 safety data exists for tDCS treatment?

Transcranial Direct Current Stimulation (tDCS) is generally considered safe with mild and transient adverse effects such as itching, tingling, headache, burning sensation, and discomfort. A systematic review of 209 studies found that these effects were not significantly more frequent in active tDCS groups compared to sham groups. No serious adverse effects or irreversible injuries have been reported in over 33,200 sessions and 1000 subjects, including vulnerable populations. However, there is a need for improved systematic reporting of adverse effects in tDCS studies. ^{1 2 3 4 5}

Is Transcranial Direct Current Stimulation (tDCS) a promising treatment for chronic pain?

Yes, Transcranial Direct Current Stimulation (tDCS) is considered a promising treatment for chronic pain. It is a noninvasive method that can help reduce pain by changing how the brain processes pain signals. Studies have shown that it can effectively decrease pain levels in people with chronic pain. ^{6 7 8 9 10}

What data supports the idea that tDCS for Chronic Pain is an effective treatment?

The available research shows that transcranial direct current stimulation (tDCS) can help reduce chronic pain. One study found that using tDCS over the motor cortex, a part of the brain involved in movement, can improve chronic pain by changing brain activity. Another study reviewed multiple research articles and found that tDCS can lower pain levels in people with chronic pain. These findings suggest that tDCS is a promising treatment for managing chronic pain. ^{6 7 8 10 11}

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]

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]

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]

Citations

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

Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. [2022]

2. Norway pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation for chronic pain]. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Transcranial direct-current stimulation reduces nociceptive behaviour in an orofacial pain model. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Does anodal transcranial direct current stimulation modulate sensory perception and pain? A meta-analysis study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

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

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

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

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

10. 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]

11. England pubmed.ncbi.nlm.nih.gov

Methods and strategies of tDCS for the treatment of pain: current status and future directions. [2023]