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Procedure

tDCS for Chronic Pain (tDCS-pain Trial)

N/A

Recruiting

Led By Guillume Léonard

Research Sponsored by Université de Sherbrooke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Patients taking medications that act on the GABAergic and glutamatergic systems (modulating tDCS effects) will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up i. 1 week before the intervention

Summary

This trial will test if real tDCS can help reduce pain in elderly people with chronic moderate-severe pain. Participants, assessors, and tDCS providers will be blinded in the study.

Who is the study for?

This trial is for seniors aged 65 or older with chronic musculoskeletal pain lasting over 6 months and rated at least moderate in severity. It's not suitable for those with conditions that make tDCS unsafe, like certain contraindications to tDCS, TMS, IRM, or if a health professional thinks the study might harm them. People on medications affecting GABAergic and glutamatergic systems are also excluded.

What is being tested?

The study tests whether actual transcranial direct current stimulation (tDCS) can reduce chronic pain in older adults compared to a placebo version of the same treatment. Participants will be randomly assigned to receive either real or sham tDCS daily for five days and followed up after one week and three months.

What are the potential side effects?

While specific side effects aren't listed here, typical ones from tDCS may include mild tingling, itching or discomfort at the electrode site during application. Serious side effects are rare but could involve headaches or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

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I have had pain in my muscles or bones for over 6 months, rated at least 4 out of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on medications that affect GABA or glutamate in the brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ mean of patient reported pain on 5 consecutive days: i. 1 week before the intervention compared to1 week after the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~mean of patient reported pain on 5 consecutive days: i. 1 week before the intervention compared to1 week after the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and mean of patient reported pain on 5 consecutive days: i. 1 week before the intervention compared to1 week after the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Secondary study objectives

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

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

Change in perception of change with treatment from 1 week to 3 months after intervention

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Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: actual tDCSExperimental Treatment1 Intervention

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.

Group II: placebo tDCSPlacebo Group1 Intervention

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).

0 / 3Eligibility criteria met