Recruiting

Transcranial Direct Current Stimulation

Sponsor:

Université de Sherbrooke

Code:

NCT05617027

Conditions

Pain, Chronic

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

actual transcranial direct current stimulation (tDCS)

placebo transcranial direct current stimulation (tDCS)

Study Details

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).

Conditions

Pain, Chronic

Study ID

NCT05617027

Start date

Oct 19, 2023

Status verified date

Jul, 2024

Completion date

Jun 1, 2025

Anticipated

Primary completion date

May 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: actual tDCS

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.

placebo comparator: placebo tDCS

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).

Interventions

actual 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.

placebo 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.

Primary outcome measure

  • Change in pain intensity from baseline to 1 week after the intervention [ Time Frame: Mean of Patient reported pain on 5 consecutive days: i. 1 week before the intervention compared to1 week after the intervention ]
  • Maintenance of the effect on pain after from to 1 week to 3 months after intervention [ Time Frame: Mean of Patient reported pain on 5 consecutive days: 3 months after the intervention to see if the effect of the treatment is maintained. ]

Central Contacts and Locations

Central contacts

Marie-Philippe Harvey, Ph. D

819 821-8000marie.philippe.harvey@usherbrooke.ca

Guillaume Léonard, Ph. D

819-780-2220guillaume.leonard2@usherbrooke.ca

Locations

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

Recruiting

Montréal, Quebec, Canada, H3S 2J4

Contacts

Camille Proulx, M. Sc, erg.

camille.proulx.1@umontreal.ca

Principal Investigator:

Johanne Higgins, Ph. D

CHU de Québec-Université Laval

Recruiting

Québec, Quebec, Canada, G1V 4G2

Contacts

Estelle Gouriou, Ph. D

418-525-4444estelle.gouriou@crchudequebec.ulaval.ca

Principal Investigator:

Cyril Schneider, Ph. D

Centre de recherche sur le vieillissement (CdRV)

Recruiting

Sherbrooke, Quebec, Canada, J1H 4C4

Contacts

Marie-Philippe Harvey, Ph.D.

819-821-8000marie.philippe.harvey@usherbrooke.ca

Guillaume Leonard, Ph.D., pht.

819-821-8000

Principal Investigator:

Guillaume Leonard

More Information

Sponsor

Université de Sherbrooke

Last update posted

Mar 4, 2025

Last verified

Jul, 2024

Keywords

  • Chronic pain
  • transcranial direct current stimulation
  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2025-03-04.