Neuropathic PainSTIRMNCT04867187
rTMS Efficacy Coupled With Mirror Therapy
A study testing Repetitive transcranial magnetic stimulation (rTMS) and Mirror therapy using virtual reality in people with Neuropathic Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.Virtual reality mirror therapy has shown the capacity to alleviate pain… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS) and Mirror therapy using virtual reality
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Oct 2022to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical symptoms typical of neuropathic pain
- Refractory to drug therapies
- Lasting for at least 6 months, with a moderate to severe pain intensity (≥4/10 on Visual Analog Scale, VAS) and a stable pain treatment since 1month at least
- Having right to health benefits
Who cannot join
- Ferromagnetic components and implanted microprocessors (i.e. cochlear implants)
- Drug-resistant or active epilepsy, pacemaker, pregnancy, ongoing depression or personality troubles, and ongoing opioid treatment.
- Any other contraindications to MRI scanner (e.g., claustrophobia, etc.).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Beatrice DEYGAS, CRA contact
France2 sites, 2 recruiting
- Not yet recruiting
Hôpital Neurologique Pierre Wertheimer
Bron, 69500
Luis Garcia-Larrea, MD, 0)472118866 ext. +33, luis-jose.garcia-larrea@chu-lyon.fr
Patrick MERTENS, MD PhD
- Recruiting
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42055
Roland PEYRON, MD PHD, (0)477825684 ext. +33, roland.peyron@chu-st-etienne.fr
Christelle Créac'h, MD
About this study
Official title: Clinical Study of Repetitive Transcranial Magnetic Stimulation (RTMS) Efficacy Coupled With Mirror Therapy for Neuropathic Pain Relief
Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS.The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy.
Read the detailed description
This project introduces a new research question that incorporates virtual reality mirror therapy into an established treatment protocol of repetitive transcranial magnetic stimulation (rTMS) for neuropathic pain relief. Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.
Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS. The efficacy of using both techniques in neuropathic pain treatment is unknown. The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy on: 1) daily pain intensity (i.e. analgesic efficacy); 2) other components of pain and the quality of life; 3) brain activity.
It will be the first to provide insight into the efficacy of using together both non-invasive technics of cortical neuromodulation to alleviate pain.
- Conditions
- Neuropathic Pain
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS), Mirror therapy using virtual reality, Mirror therapy using sham mirror
- Keywords
- transcranial magnetic stimulation, virtual reality, mirror therapy, brain networks, predictive model
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Other
20 minutes of high frequency (20Hz) rTMS.
Mirror therapy using virtual realityOther
active mirror-based therapy
Mirror therapy using sham mirrorOther
20 minutes of sham mirror-based therapy
| Study group | Role | What they receive |
|---|---|---|
| rTMS active and active mirror-based therapy using virtual reality | Experimental | The patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and active mirror-based therapy using virtual reality. Receives: Other: Repetitive transcranial magnetic stimulation (rTMS); Other: Mirror therapy using virtual reality |
| rTMS active and sham mirror-based therapy using virtual reality | Sham comparator | The patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and sham mirror-based therapy using virtual reality. Receives: Other: Repetitive transcranial magnetic stimulation (rTMS); Other: Mirror therapy using sham mirror |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measurement
Averages of the daily visual analogue scale scores (min no pain max pain imaginable) measured during the first week (Week 1) and that measured during the week following the last session (week 9)
Measured: Week 9
Secondary outcomes (4)
Quality of life after treatment
EQ5D scale (min = 0 worst imaginable health condition and max = 100 best health condition imaginable) and Analgesic consumption of Appeal
Measured: week 12
Spontaneous brain activity
Functional MRI at rest
Measured: week 12
neuropathic dimension
overall score of the neuropathic pain symptoms inventory (NPSI) (min = 0 no neuropathic pain and max = 100 intensive neuropathic pain)
Measured: Week 3, 5, 7, 9,12
Adverse events
Nature and number of adverse events
Measured: Week 3, 5, 7, 9,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start27 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic 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
- Model description
- Group 1: patient with 4 sessions of active mirror therapy followed by an rTMS stimulation session of the primary motor cortex (M1), Group 2: patient with 4 sessions of sham mirror therapy followed by rTMS of the primary motor cortex (M1).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Peyron, MDPHD, Principal investigator, CENTRE HOSPITALIER DE SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867187
- Sponsor's protocol ID
- 21CH035
- Other IDs
- 2021-A00720-41
- Acronym
- STIRM
- Status last verified
- May 2026
- First submitted
- 27 Apr 2021
- Last updated
- 8 May 2026
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Repetitive Transcranial Magnetic Stimulation (RTMS) Efficacy Coupled With Mirror Therapy for Neuropathic Pain Relief
- ClinicalTrials.gov ID
- NCT04867187
- Acronym / sponsor ID
- STIRM / 21CH035
- Conditions
- Neuropathic Pain
- Keywords
- transcranial magnetic stimulation, virtual reality, mirror therapy, brain networks, predictive model
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 30 Apr 2021 (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.
Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS.The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy.
Detailed description
This project introduces a new research question that incorporates virtual reality mirror therapy into an established treatment protocol of repetitive transcranial magnetic stimulation (rTMS) for neuropathic pain relief. Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.
Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS. The efficacy of using both techniques in neuropathic pain treatment is unknown. The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy on: 1) daily pain intensity (i.e. analgesic efficacy); 2) other components of pain and the quality of life; 3) brain activity.
It will be the first to provide insight into the efficacy of using together both non-invasive technics of cortical neuromodulation to alleviate pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Group 1: patient with 4 sessions of active mirror therapy followed by an rTMS stimulation session of the primary motor cortex (M1), Group 2: patient with 4 sessions of sham mirror therapy followed by rTMS of the primary motor cortex (M1).
| Arm | Type | Receives |
|---|---|---|
| rTMS active and active mirror-based therapy using virtual reality | Experimental | Other: Repetitive transcranial magnetic stimulation (rTMS), Other: Mirror therapy using virtual realityThe patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and active mirror-based therapy using virtual reality. |
| rTMS active and sham mirror-based therapy using virtual reality | Sham comparator | Other: Repetitive transcranial magnetic stimulation (rTMS), Other: Mirror therapy using sham mirrorThe patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and sham mirror-based therapy using virtual reality. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical symptoms typical of neuropathic pain
- Refractory to drug therapies
- Lasting for at least 6 months, with a moderate to severe pain intensity (≥4/10 on Visual Analog Scale, VAS) and a stable pain treatment since 1month at least
- Having right to health benefits
Key exclusion criteria (3 listed)
- Ferromagnetic components and implanted microprocessors (i.e. cochlear implants)
- Drug-resistant or active epilepsy, pacemaker, pregnancy, ongoing depression or personality troubles, and ongoing opioid treatment.
- Any other contraindications to MRI scanner (e.g., claustrophobia, etc.).
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)20 minutes of high frequency (20Hz) rTMS. | Other | rTMS active and active mirror-based therapy using virtual reality, rTMS active and sham mirror-based therapy using virtual reality |
| Mirror therapy using virtual realityactive mirror-based therapy | Other | rTMS active and active mirror-based therapy using virtual reality |
| Mirror therapy using sham mirror20 minutes of sham mirror-based therapy | Other | rTMS active and sham mirror-based therapy using virtual reality |
Primary outcome
Pain intensity measurement
Time frame: Week 9
Averages of the daily visual analogue scale scores (min no pain max pain imaginable) measured during the first week (Week 1) and that measured during the week following the last session (week 9)
4 secondary outcomes
Quality of life after treatment
Time frame: week 12
Spontaneous brain activity
Time frame: week 12
neuropathic dimension
Time frame: Week 3, 5, 7, 9,12
Adverse events
Time frame: Week 3, 5, 7, 9,12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- 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.
Beatrice DEYGAS, CRA contact
Roland Peyron, MDPHD principal investigator
CENTRE HOSPITALIER DE SAINT-ETIENNE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation (rTMS) and Mirror therapy using virtual reality in people with Neuropathic Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 2 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland Peyron, MDPHD ((0)477825684 ext. +33, roland.peyron@univ-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measurement (time frame: Week 9). 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 8 May 2026.