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NCT Number: NCT07187219

Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PEYRON Roland

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Roland PEYRON, PhD

CONTACT

[email protected]

0477824095 ext. 33

Roland PEYRON, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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.

Exclusion criteria

  • 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
  • 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).

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS) - active

Device

rTMS session active on the primary motor cortex

Repetitive transcranial magnetic stimulation (rTMS) - inactive

Device

rTMS session inactive on the primary motor cortex

Primary outcomes

  1. PAIN RELIEF

    Time frame: Week 7 after the start of RTMs stimulation

    PAIN from 0% : no pain relief at all to 100%: completely relief.

Secondary outcomes

  1. Pain Intensity with Visual analog scale (VAS)

    Time frame: day 7 post RTMs stimulation

    0 no pain to 10 extremely pain

  2. score of Neuropathic Pain Symptom Inventory - NPSI

    Time frame: day 7 post RTMs stimulation

    [0= zero neuropatthic pain to 100= maximum neuropathic pain]

  3. Brief Pain Inventory - BPI

    Time frame: day 7 post RTMs stimulation

    1 - 4 = Mild Pain. 5 =Worst Pain Score 6 = Moderate Pain. 7=Worst Pain Score 10 = Severe Pain.

  4. Pain relief

    Time frame: day 7 post RTMs stimulation

    scale ranging from 0% = no relief to 100% = fully relieved

  5. Visual Analogic Scale VAS on emotional dimension of pain

    Time frame: day 7 post RTMs stimulation

    Visual Analogic Scale VAS (0 = not unpleasant) to 10 = extremely unpleasant)

  6. Visual Analogic Scale (VAS) on attentional dimension of pain

    Time frame: day 7 post RTMs stimulation

    0 = does not attract at all to 10 = completely attracts

  7. consumption of rescue analgesics

    Time frame: Week 7 after the start of RTMs stimlulation

  8. Effect of rTMS on quality of life

    Time frame: Week 7 after the start of RTMs stimlulation

    Quality of life score (EQ-5D) from 0 to 100. 100 corresponds to the best health.

  9. HADS: Hospital Anxiety and Depression Scale

    Time frame: Week 7 after the start of RTMs stimlulation

    from 0 to 14: no anxiety disorders; from 15 to 42: existence of anxiety disorders.

  10. Tolerance

    Time frame: week 7 after the start of RTMs stimulation

    Tolerance will be defined as the absence of adverse effects throughout the duration of the protocol, as reported in systematic questionnaires."

Study contacts

Contact information is provided by the study sponsor or research team.

Roland PEYRON, PhD

CONTACT

[email protected]

0477824095 ext. 33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer: Cross-over and Placebo-control Study

Acronym: NeuroCanPain

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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