Chronic PainNCT04332939
Motor System Activation With Transcranial Direct Current Stimulation and Physical Exercise to Reduce Pain in Elderly
A study testing transcranial direct current stimulation and Physical exercise in people with Chronic Pain, run by Université de Sherbrooke at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- transcranial direct current stimulation and Physical exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Dec 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To have musculoskeletal chronic pain
- Not to change medication and life habits during the study
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Research Centre on Aging
Sherbrooke, Quebec, J1H 4C4
Guillaume Léonard, pht, PhD, 1 819-780-2220 ext. 45246, guillaume.leonard2@usherbrooke.ca
- Recruiting
Grace Village
Sherbrooke, Quebec, J1M 0C6
Guillaume Léonard, pht, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- transcranial direct current stimulation, Physical exercise
- Keywords
- transcranial direct current stimulation, physical exercise, corticospinal projections
- Medical subject headings
- Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationOther
real tDCS sessions
Physical exerciseOther
Aerobic exercise and physical training combined with sham tDCS
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain intensity
Pain intensity will be assessed with a pain logbook containing a numerical rating scale from 0 to 10
Measured: 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)
Corticospinal tract excitability will be assessed with transcranial magnetic stimulation (TMS)
Measured: 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
Measured: Before intervention, Follow-up 1 week after, Follow-up 1 month after
Functional connectivity
Functional connectivity will be assessed with functional magnetic resonance imaging
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Dec 2020
- Primary completion1 Oct 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume Léonard, Université de Sherbrooke
- Investigators
- Guillaume Léonard, pht, PhD., Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332939
- Sponsor's protocol ID
- 2020-3273
- Status last verified
- Mar 2023
- First submitted
- 23 Jan 2020
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Motor System to Relieve Pain in Elderly: What is the Role of Physical Exercise and Transcranial Stimulation
- ClinicalTrials.gov ID
- NCT04332939
- Acronym / sponsor ID
- 2020-3273
- Conditions
- Chronic Pain
- Keywords
- transcranial direct current stimulation, physical exercise, corticospinal projections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + real tDCS | Experimental | Other: transcranial direct current stimulation, Other: Physical exerciseIntervention 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). |
| Exercise + Sham tDCS | Sham comparator | Other: Physical exerciseIntervention 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To have musculoskeletal chronic pain
- Not to change medication and life habits during the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationreal tDCS sessions | Other | Exercise + real tDCS |
| Physical exerciseAerobic exercise and physical training combined with sham tDCS | Other | Exercise + Sham tDCS, Exercise + real tDCS |
Primary outcome
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
11 secondary outcomes
Corticospinal excitability (TMS)
Time frame: 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
Functional connectivity
Time frame: 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
Brief pain inventory
Time frame: 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 anxiety inventory
Time frame: 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
Patient global impression of change questionnaire
Time frame: 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
Pain catastrophizing scale
Time frame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Léonard, pht, PhD. principal investigator
Université de Sherbrooke
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation and Physical exercise in people with Chronic Pain, run by Université de Sherbrooke at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Léonard, PhD. pht (1 819-780-2220 ext. 45246, guillaume.leonard2@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.