Multiple Sclerosis With Central Neuropathic PainPhase 3STIMASEPNCT02059096
Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis
A Phase 3 study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Multiple Sclerosis With Central Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 3 sites in France.
Trial summary
This study is designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of chronic pain. Participants will be patients with Multiple Sclerosis suffering from chronic pain of neurological origin. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis With Central Neuropathic Pain
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesFrance
- Study dates
- 5 Jan 2014to Feb 2023
- Phase
- Phase 3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- relapsing-remitting Multiple Sclerosis
- 18 to 60 years
- central neuropathic pain with a DN4 score of 4 or more out of 10
- average pain of at least 4/10
- presence of pain at least 4 days per week
- presence of pain for at least 3 months
- stable analgesic treatment
Who cannot join
- relapse during the previous 30 days
- contraindication for rTMS
- peripheral neuropathic pain
- severe depression
- epilepsia
- resting motor threshold above 75%
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
CHU Ambroise Paré
Boulogne-Billancourt
Didier BOUHASSIRA
Didier BOUHASSIRA
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Lise Laclautre, 04 73 75 4963, promo_interne_drci@chu-clermontferrand.fr
Pierre Clavelou
- Recruiting
Hôpital Henri Mondor
Créteil
Jean-Pascal Lefaucheur
Jean-Pascal Lefaucheur
About this study
This study is designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of chronic pain. Participants will be patients with Multiple Sclerosis suffering from chronic pain of neurological origin.
Read the detailed description
On the one hand, Multiple Sclerosis (MS) is the most frequent chronic disease generating neurological disability in young adults. Among the many types of disabilities associated with MS, chronic pain is very frequent, especially neuropathic pain. This type of pain is often treatment resistant. Moreover, abnormal intra-cortical excitability has been described in MS patients.
On the other hand, repetitive Transcranial Magnetic Stimulation (rTMS) has shown an analgesic effect in various chronic pain conditions (fibromyalgia, post-stroke, peripheral neuropathic pain). Three groups have shown that analgesia was correlated to defective intra-cortical excitability restoration.
The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation.
Patients will benefit from 1 daily session per day for 5 consecutive days and from a total follow up of 4 weeks. Pain will be assessed each day and several other signs and symptoms will be repeatedly assessed.
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- Multiple Sclerosis, Repetitive transcranial magnetic stimulation (rTMS), Chronic neuropathic pain, Cortical excitability
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
| Study group | Role | What they receive |
|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS) | Experimental | The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Theta-Burst Stimulation (pcTBS) | Other | The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| repetitive Transcranial Magnetic Stimulation (rTMS)placebo | Other | The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in "average pain" score on the brief pain inventory
Variation of the "Average pain" score on the Brief Pain Inventory between before treatment (on a 7 days period) and day 8.
Measured: at day 8
Secondary outcomes (5)
change from baseline in "average pain" score on the brief pain inventory
Variation of the average pain at several time-points during the 4 weeks follow-up
Measured: at weekk 3 and 4
Location of MRI abnormalities
Correlation between pain and pain decrease with MRI abnormalities in several regions of interest
Measured: at week 3 and 4
Intra-cortical excitability evaluated by motor threshold, MEP amplitude, SICI and ICF
Measured: at week 3 and 4
Number of participants with adverse events as a measure of safety and tolerability
Measured: at day 1
change from baseline in specific questionnaires
Measured: at day 8, week 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study start5 Jan 2014
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis With Central Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier MOISSET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059096
- Sponsor's protocol ID
- CHU-0179
- Other IDs
- 2013-A01422-43
- Acronym
- STIMASEP
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2014
- Last updated
- 16 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02059096
- Acronym / sponsor ID
- STIMASEP / CHU-0179
- Keywords
- Multiple Sclerosis, Repetitive transcranial magnetic stimulation (rTMS), Chronic neuropathic pain, Cortical excitability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 5 Jan 2014 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 11 Feb 2014 (estimated)
- 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.
This study is designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of chronic pain. Participants will be patients with Multiple Sclerosis suffering from chronic pain of neurological origin.
Detailed description
On the one hand, Multiple Sclerosis (MS) is the most frequent chronic disease generating neurological disability in young adults. Among the many types of disabilities associated with MS, chronic pain is very frequent, especially neuropathic pain. This type of pain is often treatment resistant. Moreover, abnormal intra-cortical excitability has been described in MS patients.
On the other hand, repetitive Transcranial Magnetic Stimulation (rTMS) has shown an analgesic effect in various chronic pain conditions (fibromyalgia, post-stroke, peripheral neuropathic pain). Three groups have shown that analgesia was correlated to defective intra-cortical excitability restoration.
The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation.
Patients will benefit from 1 daily session per day for 5 consecutive days and from a total follow up of 4 weeks. Pain will be assessed each day and several other signs and symptoms will be repeatedly assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS) | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation |
| Theta-Burst Stimulation (pcTBS) | Other | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation. |
| repetitive Transcranial Magnetic Stimulation (rTMS)placebo | Other | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- relapsing-remitting Multiple Sclerosis
- 18 to 60 years
- central neuropathic pain with a DN4 score of 4 or more out of 10
- average pain of at least 4/10
- presence of pain at least 4 days per week
Key exclusion criteria (6 listed)
- relapse during the previous 30 days
- contraindication for rTMS
- peripheral neuropathic pain
- severe depression
- epilepsia
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | Repetitive transcranial magnetic stimulation (rTMS), Theta-Burst Stimulation (pcTBS), repetitive Transcranial Magnetic Stimulation (rTMS)placebo |
Primary outcome
Change from baseline in "average pain" score on the brief pain inventory
Time frame: at day 8
Variation of the "Average pain" score on the Brief Pain Inventory between before treatment (on a 7 days period) and day 8.
5 secondary outcomes
change from baseline in "average pain" score on the brief pain inventory
Time frame: at weekk 3 and 4
Location of MRI abnormalities
Time frame: at week 3 and 4
Intra-cortical excitability evaluated by motor threshold, MEP amplitude, SICI and ICF
Time frame: at week 3 and 4
Number of participants with adverse events as a measure of safety and tolerability
Time frame: at day 1
change from baseline in specific questionnaires
Time frame: at day 8, week 3 and 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
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.
Xavier MOISSET principal investigator
University Hospital, Clermont-Ferrand
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Multiple Sclerosis With Central Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 3 sites in France.
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 7 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 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lise LACLAUTRE (04 73 75 4963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in "average pain" score on the brief pain inventory (time frame: at day 8). 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 16 Feb 2021.