Motor System Activation With Transcranial Direct Current Stimulation and Physical Exercise to Reduce Pain in Elderly

Activating Motor System to Relieve Pain in Elderly: What is the Role of Physical Exercise and Transcranial Stimulation

Physical exercises are known to reduce chronic pain in elderly individuals by activating the motor system. However, it seems that exercises are not effective for everyone. The investigators believe that elderly individuals with altered corticospinal tract will be those in whom the exercise alone are not sufficient to relieve pain. For those patients, adding an exogenous stimulation of the motor system such as transcranial direct current stimulation (tDCS) would facilitate the corticospinal tract, and consequently, would help exercises to relieve chronic pain. The investigators hypothesize that combining tDCS with the exercises will be more effective than exercises alone, but only in individuals who initially show low corticospinal projections.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Other: transcranial direct current stimulation; Other: Physical exercise

Detailed Description

Prevalence and intensity of chronic pain increases substantially with age. According to several studies, physical exercises are effective to reduce chronic pain in elderly. However, it seems that exercises are not effective for everyone. One of the hypotheses raised is that the people in whom the exercises have no effect would be those with an alteration of the corticospinal tract. Transcranial direct current stimulation (tDCS) is a non-invasive neurostimulation technique known to facilitate the corticospinal tract when applied over the motor cortex.

Elderly suffering from chronic pain will be recruited in this double-blind, parallel-group, randomised control trial. Participants will be randomized to receive exercises combined to real tDCS (5 daily sessions, 2 mA, 20 minutes) or to sham tDCS. Intervention will last 8 weeks at a rate of 3 workouts per week.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume Léonard, PhD. pht; Phone Number: 45246 1 819-780-2220; Email: guillaume.leonard2@usherbrooke.ca
• Study Contact Backup: Name: Marie-Philippe HArvey, M.Sc; Phone Number: 45156 1 819-780-2220; Email: marie.philippe.harvey@usherbrooke.ca

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 4C4
      • Recruiting
      • Research Centre on Aging
      • Contact: Guillaume Léonard, pht, PhD; Phone Number: 45246 1 819-780-2220; Email: guillaume.leonard2@usherbrooke.ca
    • Sherbrooke, Quebec, Canada, J1M 0C6
      • Recruiting
      • Grace Village
      • Contact: Guillaume Léonard, pht, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• To have musculoskeletal chronic pain
• Not to change medication and life habits during the study

Exclusion Criteria:

• People physically active before the study (more then 150 min of moderate to vigorous exercise par week)
• To have an uncontrolled cardiovascular disease
• To have orthopedic limitation or contraindication to physical exercise
• To have contraindication to tDCS
• To have contraindication to TMS
• To have contraindication to MRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise + real tDCS; Intervention will last 8 weeks where participants will be trained at a rate of 3 workouts per week. For the first week, participants will receive 5 daily sessions of anodal tDCS (2 mA, 20 min).	Other: transcranial direct current stimulation; real tDCS sessions; Other: Physical exercise; Aerobic exercise and physical training combined with sham tDCS
Sham Comparator: Exercise + Sham tDCS; Intervention will last 8 weeks where participants will be trained at a rate of 3 workouts per week. For the first week, participants will receive 5 daily sessions of sham tDCS.	Other: Physical exercise; Aerobic exercise and physical training combined with sham tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Pain intensity	Pain intensity will be assessed with a pain logbook containing a numerical rating scale from 0 to 10	Before intervention (T1), First week of intervention (T2), Week 4 (T3), Week 8 (T4), Follow-up 1 week after intervention (T5), Follow-up 1 month after intervention (T6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corticospinal excitability (TMS)	Corticospinal tract excitability will be assessed with transcranial magnetic stimulation (TMS)	Before intervention, Follow-up 1 week after, Follow-up 1 month after
Corticospinal excitability (dMRI)	Corticospinal tract excitability will be assessed diffusion magnetic resonance imaging	Before intervention, Follow-up 1 week after, Follow-up 1 month after
Functional connectivity	Functional connectivity will be assessed with functional magnetic resonance imaging	Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
McGill pain questionnaire	McGill pain questionnaire will be used to assess pain in its globality. Score from 0 to 72, higher score means worse outcome.	Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Brief pain inventory	Brief pain inventory will be used to assess pain in its globality. Score from 0 to 70, higher score means worse outcome	Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Beck depression inventory	Beck depression inventory will be used to assess pain in its globality. Score from 0 to 39, higher score means worse outcome	Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Beck anxiety inventory	Beck anxiety inventory will be used to assess pain in its globality. Score from 0 to 63, higher score means worse outcome	Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Margolis pain drawing and scoring system	Margolis pain drawing and scoring system will be used to assess pain in its globality. Score from 0 to 45, higher score means worse outcome	Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Patient global impression of change questionnaire	patient global impression of change questionnaire will be used to assess pain in its globality. Score from 0 to 18 and a percentage from 0 to 100. Higher scores mean better outcome	Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Tampa questionnaire	Tampa questionnaire will be used to assess pain in its globality. Score from 0 to 68, higher score means worse outcome	Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Pain catastrophizing scale	Pain catastrophizing scale will be used to assess pain in its globality. Score from 0 to 52, higher score means worse outcome	Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Guillaume Léonard, pht, PhD., Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; physical exercise; corticospinal projections
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2020-3273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No