Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT07187219

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

Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2025-09-22

60

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient affiliated to or entitled under a social security scheme
  • Patient who has received informed information about the study and who has co-signed a consent form
  • Patient aged 18 to 85 years, male or female
  • Central or peripheral neuropathic pain related to cancer and/or its treatment
  • Chronic pain lasting more than 4 months with intensity ≥4/10 on a Visual Analogue Scale
  • Pain present daily or at least 4 days per week
  • Pain not fully relieved by first- and second-line drug treatments for neuropathic pain
  • Stable analgesic treatment for at least one month with no planned changes during the study
  • Patient can be followed throughout the study
  • Indication for rTMS of the motor cortex by a neurologist
Not Eligible

You will not qualify if you...

  • Accident at work or litigation
  • Contraindications to rTMS or MRI (recent seismotherapy, cranial trauma, intracranial hypertension, metal implants, pacemaker, insulin pump, metal prosthesis, pregnancy or breastfeeding, claustrophobia)
  • Chronic alcoholism
  • Abuse of drugs or psychoactive substances
  • Neuropathic pain from progressive diseases (e.g., HIV)
  • Presence of other pain more intense than neuropathic pain
  • Acute stroke within the last 3 months
  • Brain tumor lesions
  • Infectious or metabolic brain lesions
  • Severe or recent cardiac disorders
  • Cognitive impairment
  • Inability to understand informed consent
  • Refusal or inability to stop prohibited treatments such as morphine
  • Participation in another drug trial within 30 days
  • Deprivation of liberty or under legal protection (guardianship, curatorship, safeguard of justice, family habilitation)

AI-Screening

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Trial Site Locations

Total: 1 location

1

PEYRON Roland

Saint-Etienne, France, 42055

Actively Recruiting

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Research Team

R

Roland PEYRON, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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