RecruitingNot ApplicableNCT05617027

Relieving Chronic Pain in Older Adults With Transcranial Direct Current Stimulation

Sponsor

Université de Sherbrooke

Enrollment

150 participants

Start Date

Oct 19, 2023

Study Type

INTERVENTIONAL

Conditions

Pain, Chronic

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

Min Age: 65 Years

Inclusion Criteria2

Be aged ≥ 65 years
Have chronic (≥ 6 months) musculoskeletal pain of moderate to severe intensity (≥4 out of 10 on a numerical scale of 0 to 10)

Exclusion Criteria7

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 has another medical condition that could put them at risk in the judgment of a health care 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 not excluded but will be asked, in the absence of clinical contraindication, to avoid any modification (e.g., new treatment, discontinuation, or change in dose) during the study.
People with epilepsy and seizures will not be excluded from the study. The research team will simply be asked to pay closer attention to these participants during the administration of MST.

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Interventions

OTHERactual transcranial direct current stimulation (tDCS)

tDCS is a non-invasive brain stimulation technique that would influence the brain's pain control mechanisms. The anode is attached to the skull above the M1 opposite the painful side (in case of unilateral pain) or opposite the dominant hand (in case of bilateral pain). The cathode (at the supraorbital level opposite the stimulated M1) will be positioned using the 10-20 EEG system and the tDCS intensity will be 2 mA.

OTHERplacebo transcranial direct current stimulation (tDCS)

The anode is attached to the skull above the M1 opposite the painful side (in case of unilateral pain) or opposite the dominant hand (in case of bilateral pain). The cathode (at the supraorbital level opposite the stimulated M1) will be positioned using the 10-20 EEG system and the tDCS intensity will be 2 mA for 30 secondes, and then 0 mA for the rest of the 20-minute session.