NCT05617027 Relieving Chronic Pain in Older Adults With Transcranial Direct Current Stimulation
| NCT ID | NCT05617027 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Université de Sherbrooke |
| Condition | Pain, Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-10-19 |
| Primary Completion | 2025-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-10-19 with a primary completion date of 2025-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria: * 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 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 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.
Contact & Investigator
Guillume Léonard
PRINCIPAL INVESTIGATOR
Université de Sherbrooke
Frequently Asked Questions
Who can join the NCT05617027 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Pain, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05617027 currently recruiting?
Yes, NCT05617027 is actively recruiting participants. Contact the research team at marie.philippe.harvey@usherbrooke.ca for enrollment information.
Where is the NCT05617027 trial being conducted?
This trial is being conducted at Montreal, Canada, Québec, Canada, Sherbrooke, Canada.
Who is sponsoring the NCT05617027 clinical trial?
NCT05617027 is sponsored by Université de Sherbrooke. The principal investigator is Guillume Léonard at Université de Sherbrooke. The trial plans to enroll 150 participants.