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

March 24, 2023 updated by: Guillaume Léonard, Université de Sherbrooke

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 4C4
      • Sherbrooke, Quebec, Canada, J1M 0C6
        • Recruiting
        • Grace Village
        • Contact:
          • Guillaume Léonard, pht, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Pain intensity
Time Frame: 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)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Corticospinal excitability (TMS)
Time Frame: Before intervention, Follow-up 1 week after, Follow-up 1 month after
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)
Time Frame: Before intervention, Follow-up 1 week after, Follow-up 1 month after
Corticospinal tract excitability will be assessed diffusion magnetic resonance imaging
Before intervention, Follow-up 1 week after, Follow-up 1 month after
Functional connectivity
Time Frame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
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
Time Frame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
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
Time Frame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
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
Time Frame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
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
Time Frame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
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
Time Frame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
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
Time Frame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
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
Time Frame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
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
Time Frame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université de Sherbrooke

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guillaume Léonard, pht, PhD., Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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