Relieving Chronic Pain in Older Adults with Transcranial Direct Current Stimulation

Last updated: February 27, 2025
Sponsor: Université de Sherbrooke
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Chronic Pain

Treatment

placebo transcranial direct current stimulation (tDCS)

actual transcranial direct current stimulation (tDCS)

Clinical Study ID

NCT05617027
MP-31-2022-4641
  • Ages > 65
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be aged ≥ 65 years

  • Have chronic (≥ 6 months) musculoskeletal pain of moderate to severe intensity (≥4out of 10 on a numerical scale of 0 to 10)

Exclusion

Exclusion Criteria:

  • Those with contraindications to tDCS

  • Those with contraindications to TMS

  • Those with contraindications to IRM

  • Individuals for whom the procedure could cause impairment of well-being, or hasanother medical condition that could put them at risk in the judgment of a healthcare professional.

  • Patients taking medications that act on the GABAergic and glutamatergic systems (modulating tDCS effects) will be excluded

  • Individuals taking other types of medications or receiving rehabilitation are notexcluded but will be asked, in the absence of clinical contraindication, to avoidany modification (e.g., new treatment, discontinuation, or change in dose) duringthe study.

  • People with epilepsy and seizures will not be excluded from the study. The researchteam will simply be asked to pay closer attention to these participants during theadministration of MST.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: placebo transcranial direct current stimulation (tDCS)
Phase:
Study Start date:
October 19, 2023
Estimated Completion Date:
June 01, 2025

Study Description

Rationale : Chronic pain is the leading cause of disability and affects a large number of seniors. Transcranial direct current stimulation (tDCS), which provides non-invasive stimulation of the brain, is a promising avenue for relieving pain that is refractory to traditional treatments. To date, however, its clinical efficacy has yet to be confirmed in the elderly.

Objectives : 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. Secondary objectives are to assess the effect of tDCS on pain-related interference and the relationship between the response to tDCS and the integrity of pain control systems (descending pathways controlling pain circuits).

Methods : 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: Sherbrooke (n=1), Quebec City (n=2), Montreal (n=2). 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), i.e., the integrity of corticothalamic and corticospinal projections will be tested by diffusion MRI and transcranial magnetic stimulation.

Anticipated results: Our hypotheses are that (i) real tDCS will be more effective in reducing pain intensity than placebo tDCS at 1 week post-treatment. This reduction in pain will be maintained at the 3-month post-treatment follow-up of real tDCS. (ii) Real tDCS will be more effective than placebo treatment in reducing pain interference with physical function, mood and quality of life. Perceived improvement with the treatment received will also be greater for real tDCS. (iii) Individuals with stronger cortico-thalamic and corticospinal projections in pre-tDCS will be more relieved by actual tDCS than those with less strong projections.

Ultimately, this study will allow us to evaluate the effectiveness of tDCS in the care setting for the relief of chronic musculoskeletal pain in the elderly and to identify those individuals most likely to respond to this type of treatment based on potential biomarkers related to the integrity of the pain control system.

Connect with a study center

  • Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM)

    Montréal, Quebec H3S 2J4
    Canada

    Active - Recruiting

  • CHU de Québec-Université Laval

    Québec, Quebec G1V 4G2
    Canada

    Active - Recruiting

  • Centre de recherche sur le vieillissement (CdRV)

    Sherbrooke, Quebec J1H 4C4
    Canada

    Active - Recruiting

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