CancerNeuroCanPainNCT07187219
Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer
A study testing Repetitive transcranial magnetic stimulation (rTMS) - active and Repetitive transcranial magnetic stimulation (rTMS) - inactive in people with Cancer and Chronic Neuropathic Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
High-frequency repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex (M1) has shown its efficacy to alleviate pain in patients suffering from refractory neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer, Chronic Neuropathic Pain
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS) - active and Repetitive transcranial magnetic stimulation (rTMS) - inactive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2025to May 2029
- 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
- Patient affiliated to or entitled under a social security scheme
- Patient who has received informed information about the study and who has co-signed, with the investigator, a consent form to participate in the study.
- Patient aged 18 to 85 (male or female),
- Central or peripheral neuropathic pain related to cancer and/or its treatment;
- Chronic pain (present for more than 4 months) whose intensity is greater than or equal to 4/10 on a VAS (Visual Analogue Scale) numerical scale.
- Pain present on a daily or almost daily basis (at least 4 days a week)
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- Patient not completely relieved by recommended first- and second-line drug treatments for neuropathic pain
- Stable analgesic treatment (no new treatment or dosage adjustment) for at least one month and will not need to be modified for the duration of the study.
- Patient can be followed throughout the study.
- Indication for rTMS of the motor cortex by a neurologist.
Who cannot join
- Accident at work or litigation,
- Contraindication to rTMS or MRI (treatment with seismotherapy during the previous month; history of cranial trauma; intracranial hypertension; intracerebral metal clip; piercing; pacemaker; insulin pump; metal prosthesis; pregnant or breast-feeding woman; claustrophobia).
- Chronic alcoholism
- Abuse of drugs or psychoactive substances
- Neuropathic pain as part of a progressive pathology (e.g. HIV),
- Presence of other pain of greater intensity than the neuropathic pain leading to inclusion
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- Acute stroke (< 3 months)
- Patient with brain tumour lesions
- Patient with infectious or metabolic brain lesions
- Patients with severe or recent cardiac disorders
- Patients with cognitive impairment
- Patient unable to understand informed consent,
- Patients refusing to stop or unable to stop treatments prohibited during the study, such as morphine.
- Patients participating in another research protocol involving a medicinal product within 30 days prior to inclusion.
- Patients deprived of their liberty or under legal protection (guardianship, curatorship, safeguard of justice, family habilitation).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
PEYRON Roland
Saint-Etienne, 42055
Roland PEYRON, PhD, 0477824095 ext. 33, roland.peyron@chu-st-etienne.fr
Roland PEYRON, PhD
About this study
Official title: Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer: Cross-over and Placebo-control Study
High-frequency repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex (M1) has shown its efficacy to alleviate pain in patients suffering from refractory neuropathic pain. rTMS is now considered as 3rd-line therapy (by the French Society for the Study and Treatment of Pain) for patient's refractory to drug therapy.
However, its efficacy in chronic neuropathic pain related to cancer has not yet been specifically studied, and it therefore remains relatively inaccessible for these patients. This project is a cross-over, double-blinded, and placebo-control study, including 5 sessions of either M1 or "sham" rTMS, a wash-out period (8 weeks), followed by 5 sessions of the other stimulation option (I.e., two arms: M1-sham or sham-M1; order randomized between patients). Treatment efficacy will be assessed in comparison to the placebo condition. Primary outcome is the percentage of pain relief between active and sham rTMS. Other variables to describe quality of life, sensory, neuropathic, and mood states as well as resting-state fMRI will be collected before and after treatment.
- Conditions
- Cancer, Chronic Neuropathic Pain
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS) - active, Repetitive transcranial magnetic stimulation (rTMS) - inactive
- Keywords
- Neuropathic pain, Cancer, Transcranial magnetic stimulation, Neuromodulation, Pain relief
- Medical subject headings
- Neoplasms, 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) - activeDevice
rTMS session active on the primary motor cortex
Repetitive transcranial magnetic stimulation (rTMS) - inactiveDevice
rTMS session inactive on the primary motor cortex
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS - Sham | Experimental | 5 stimulation sessions on M1 - washout 8 weeks - 5 sham stimulation sessions (placebo-control, same site, inactive stimulation) Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) - active; Device: Repetitive transcranial magnetic stimulation (rTMS) - inactive |
| Sham - Active rTMS | Experimental | 5 sham stimulation sessions (placebo-control, same site, inactive stimulation) - washout 8 weeks - 5 stimulation sessions on M1 Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) - active; Device: Repetitive transcranial magnetic stimulation (rTMS) - inactive |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAIN RELIEF
PAIN from 0% : no pain relief at all to 100%: completely relief.
Measured: Week 7 after the start of RTMs stimulation
Secondary outcomes (10)
Pain Intensity with Visual analog scale (VAS)
0 no pain to 10 extremely pain
Measured: day 7 post RTMs stimulation
score of Neuropathic Pain Symptom Inventory - NPSI
[0= zero neuropatthic pain to 100= maximum neuropathic pain]
Measured: day 7 post RTMs stimulation
Brief Pain Inventory - BPI
1 - 4 = Mild Pain. 5 =Worst Pain Score 6 = Moderate Pain. 7=Worst Pain Score 10 = Severe Pain.
Measured: day 7 post RTMs stimulation
Pain relief
scale ranging from 0% = no relief to 100% = fully relieved
Measured: day 7 post RTMs stimulation
Visual Analogic Scale VAS on emotional dimension of pain
Visual Analogic Scale VAS (0 = not unpleasant) to 10 = extremely unpleasant)
Measured: day 7 post RTMs stimulation
Visual Analogic Scale (VAS) on attentional dimension of pain
0 = does not attract at all to 10 = completely attracts
Measured: day 7 post RTMs stimulation
consumption of rescue analgesics
Measured: Week 7 after the start of RTMs stimlulation
Effect of rTMS on quality of life
Quality of life score (EQ-5D) from 0 to 100. 100 corresponds to the best health.
Measured: Week 7 after the start of RTMs stimlulation
HADS: Hospital Anxiety and Depression Scale
from 0 to 14: no anxiety disorders; from 15 to 42: existence of anxiety disorders.
Measured: Week 7 after the start of RTMs stimlulation
Tolerance
Tolerance will be defined as the absence of adverse effects throughout the duration of the protocol, as reported in systematic questionnaires."
Measured: week 7 after the start of RTMs stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start13 Jun 2025
- Primary completionNov 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This project is a cross-over, double-blinded, and placebo-control study, including 5 sessions of either M1 or "sham" rTMS, a wash-out period (8 weeks), followed by 5 sessions of the other stimulation option (I.e., two arms: M1-sham or sham-M1; order randomized between patients).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland PEYRON, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187219
- Sponsor's protocol ID
- 24CH024
- Other IDs
- 2024-A01195-42
- Acronym
- NeuroCanPain
- Status last verified
- Sep 2025
- First submitted
- 18 Jun 2025
- Last updated
- 22 Sep 2025
- 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer: Cross-over and Placebo-control Study
- ClinicalTrials.gov ID
- NCT07187219
- Acronym / sponsor ID
- NeuroCanPain / 24CH024
- Conditions
- Cancer, Chronic Neuropathic Pain
- Keywords
- Neuropathic pain, Cancer, Transcranial magnetic stimulation, Neuromodulation, Pain relief
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 22 Sep 2025 (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.
High-frequency repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex (M1) has shown its efficacy to alleviate pain in patients suffering from refractory neuropathic pain. rTMS is now considered as 3rd-line therapy (by the French Society for the Study and Treatment of Pain) for patient's refractory to drug therapy.
However, its efficacy in chronic neuropathic pain related to cancer has not yet been specifically studied, and it therefore remains relatively inaccessible for these patients. This project is a cross-over, double-blinded, and placebo-control study, including 5 sessions of either M1 or "sham" rTMS, a wash-out period (8 weeks), followed by 5 sessions of the other stimulation option (I.e., two arms: M1-sham or sham-M1; order randomized between patients). Treatment efficacy will be assessed in comparison to the placebo condition. Primary outcome is the percentage of pain relief between active and sham rTMS. Other variables to describe quality of life, sensory, neuropathic, and mood states as well as resting-state fMRI will be collected before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This project is a cross-over, double-blinded, and placebo-control study, including 5 sessions of either M1 or "sham" rTMS, a wash-out period (8 weeks), followed by 5 sessions of the other stimulation option (I.e., two arms: M1-sham or sham-M1; order randomized between patients).
| Arm | Type | Receives |
|---|---|---|
| Active rTMS - Sham | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS) - active, Device: Repetitive transcranial magnetic stimulation (rTMS) - inactive5 stimulation sessions on M1 - washout 8 weeks - 5 sham stimulation sessions (placebo-control, same site, inactive stimulation) |
| Sham - Active rTMS | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS) - active, Device: Repetitive transcranial magnetic stimulation (rTMS) - inactive5 sham stimulation sessions (placebo-control, same site, inactive stimulation) - washout 8 weeks - 5 stimulation sessions on M1 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient affiliated to or entitled under a social security scheme
- Patient who has received informed information about the study and who has co-signed, with the investigator, a consent form to participate in the study.
- Patient aged 18 to 85 (male or female),
- Central or peripheral neuropathic pain related to cancer and/or its treatment;
- Chronic pain (present for more than 4 months) whose intensity is greater than or equal to 4/10 on a VAS (Visual Analogue Scale) numerical scale.
Key exclusion criteria (15 listed)
- Accident at work or litigation,
- Contraindication to rTMS or MRI (treatment with seismotherapy during the previous month; history of cranial trauma; intracranial hypertension; intracerebral metal clip; piercing; pacemaker; insulin pump; metal prosthesis; pregnant or breast-feeding woman; claustrophobia).
- Chronic alcoholism
- Abuse of drugs or psychoactive substances
- Neuropathic pain as part of a progressive pathology (e.g. HIV),
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) - activerTMS session active on the primary motor cortex | Device | Active rTMS - Sham, Sham - Active rTMS |
| Repetitive transcranial magnetic stimulation (rTMS) - inactiverTMS session inactive on the primary motor cortex | Device | Active rTMS - Sham, Sham - Active rTMS |
Primary outcome
PAIN RELIEF
Time frame: Week 7 after the start of RTMs stimulation
PAIN from 0% : no pain relief at all to 100%: completely relief.
10 secondary outcomes
Pain Intensity with Visual analog scale (VAS)
Time frame: day 7 post RTMs stimulation
score of Neuropathic Pain Symptom Inventory - NPSI
Time frame: day 7 post RTMs stimulation
Brief Pain Inventory - BPI
Time frame: day 7 post RTMs stimulation
Pain relief
Time frame: day 7 post RTMs stimulation
Visual Analogic Scale VAS on emotional dimension of pain
Time frame: day 7 post RTMs stimulation
Visual Analogic Scale (VAS) on attentional dimension of pain
Time frame: day 7 post RTMs stimulation
consumption of rescue analgesics
Time frame: Week 7 after the start of RTMs stimlulation
Effect of rTMS on quality of life
Time frame: Week 7 after the start of RTMs stimlulation
HADS: Hospital Anxiety and Depression Scale
Time frame: Week 7 after the start of RTMs stimlulation
Tolerance
Time frame: week 7 after the start of RTMs stimulation
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 22 Sep 2025.
- 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.
Roland PEYRON, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site 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) - active and Repetitive transcranial magnetic stimulation (rTMS) - inactive in people with Cancer and Chronic Neuropathic Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site 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 10 inclusion and 15 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 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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, PhD (0477824095 ext. 33, roland.peyron@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAIN RELIEF (time frame: Week 7 after the start of RTMs stimulation). 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 22 Sep 2025.