Relieving Chronic Pain in Older Adults With Transcranial Direct Current Stimulation

NCT05617027 | Recruiting

• 1 other identifier: MP-31-2022-4641
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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

Keywords

Chronic pain; transcranial direct current stimulation; quality of life

Outcome Measures

Primary Outcomes (2)

• Change in pain intensity from baseline to 1 week after the intervention

  Visual analogue scale (0-10) where 0 = no pain, 10= worst pain

  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

  Visual analogue scale (0-10) where 0 = no pain, 10= worst pain

  Mean of Patient reported pain on 5 consecutive days: 3 months after the intervention to see if the effect of the treatment is maintained.

Secondary Outcomes (8)

• Sociodemographic, life habits, and medical history data

  Selection visit (pre-intervention)

• Change in affective component of pain from baseline to 1 week and 3 months after intervention

  i. 1 week before the intervention, ii. 1 week after the intervention, and iii. 3 months after the intervention

• Change in mood from baseline to 1 week and 3 months after intervention

  i. 1 week before the intervention, ii. 1 week after the intervention, and iii. 3 months after the intervention

• Change in physical function related to pain from baseline to 1 week and 3 months after intervention

  i. 1 week before the intervention, ii. 1 week after the intervention, and iii. 3 months after the intervention

• Change in quality of life covering eight domains of health from baseline to 1 week and 3 months after intervention

  i. 1 week before the intervention, ii. 1 week after the intervention, and iii. 3 months after the intervention

Study Arms (2)

actual tDCS

EXPERIMENTAL

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.

Other: actual transcranial direct current stimulation (tDCS)

placebo tDCS

PLACEBO COMPARATOR

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).

Other: placebo transcranial direct current stimulation (tDCS)

Interventions

actual transcranial direct current stimulation (tDCS) OTHER

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.

actual tDCS

placebo transcranial direct current stimulation (tDCS) OTHER

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.

placebo tDCS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (3)

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

Montreal, Quebec, H3S 2J4, Canada

RECRUITING

CHU de Québec-Université Laval

Québec, Quebec, G1V 4G2, Canada

RECRUITING

Centre de recherche sur le vieillissement (CdRV)

Sherbrooke, Quebec, J1H 4C4, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guillume Léonard

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Philippe Harvey, Ph. D

CONTACT

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

Guillaume Léonard, Ph. D

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and team members, also referred to as evaluator members above (researchers, analysts, physical therapists, and research assistants) will all be blinded to the intervention, except for those not involved in data collection and analysis: a) the statistician who will generate the randomization list, b) the computer team who will program the randomization system, and c) the interventionist who will apply the tDCS power.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter randomized controlled trial (RCT) with placebo that includes two parallel groups (real tDCS and placebo tDCS), with random assignment

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 15, 2022
• Study Start: October 19, 2023
• Primary Completion: May 15, 2025
• Study Completion: June 1, 2025
• Last Updated: March 4, 2025

Record last verified: 2024-07

Locations

CA (3)