Relieving Chronic Pain in Older Adults with Transcranial Direct Current Stimulation (tDCS-pain)

Université de Sherbrooke

Status: Enrolling

Conditions: Pain, Chronic

Treatments: Other: placebo transcranial direct current stimulation (tDCS); Other: actual transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05617027

MP-31-2022-4641

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

actual tDCS

Experimental group

Description:

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.

Treatment:

Other: actual transcranial direct current stimulation (tDCS)

placebo tDCS

Placebo Comparator group

Description:

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).

Treatment:

Other: placebo transcranial direct current stimulation (tDCS)