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

NCT04332939 | Unknown

• 1 other identifier: 2020-3273
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Pain

Keywords

transcranial direct current stimulation; physical exercise; corticospinal projections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Corticospinal excitability (TMS)

  Before intervention, Follow-up 1 week after, Follow-up 1 month after

• Corticospinal excitability (dMRI)

  Before intervention, Follow-up 1 week after, Follow-up 1 month after

• Functional connectivity

  Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention

• McGill pain questionnaire

  Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention

• Brief pain inventory

  Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention

Study Arms (2)

Exercise + real tDCS

EXPERIMENTAL

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; Other: Physical exercise

Exercise + Sham tDCS

SHAM COMPARATOR

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

Interventions

transcranial direct current stimulation OTHER

real tDCS sessions

Exercise + real tDCS

Physical exercise OTHER

Aerobic exercise and physical training combined with sham tDCS

Exercise + Sham tDCS; Exercise + real tDCS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (2)

Research Centre on Aging

Sherbrooke, Quebec, J1H 4C4, Canada

RECRUITING

Grace Village

Sherbrooke, Quebec, J1M 0C6, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Motor Activity

Interventions

Transcranial Direct Current Stimulation; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Guillaume Léonard, pht, PhD.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Léonard, PhD. pht

CONTACT

1 819-780-2220; guillaume.leonard2@usherbrooke.ca

Marie-Philippe HArvey, M.Sc

CONTACT

1 819-780-2220; marie.philippe.harvey@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: April 3, 2020
• Study Start: December 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)