Study of RTMS Analgesic Effect in Chronic Neuropathic Pain, (NEUROSTIM)

Grenoble Alpes University Hospital Center (CHU)

Status: Enrolling

Conditions: Chronic Neuropathic Pain

Treatments: Device: RepetitiveTranscranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04936646

38RC20192

Details and patient eligibility

About

The purpose of this study is to compare the analgesic effectiveness of three modes of repetitive Transcranial Magnetic Stimulation (rTMS) in chronic neuropathic pain:

• Classical rTMS stimulation
• Deeper rTMS stimulation
• Sham rTMS stimulation

Full description

Conduct of study:

• Entry into the study: After informed consent, patients will be randomised. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS). Only this physician will have the knowledge of the group allocated to the patient.
• Baseline : Patients, will record on a diary form, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 week.
• Treatment sessions: after the baseline, sessions of neurostimulation will begin for seven weeks.
• After the end of neurostimulation sessions, patients will be followed for 2 weeks.
• Throughout their participation in the study, patients will plot on a diary form their daily VNS.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient's written consent
• Affiliated with social security system
• Male or female, suffering for more than a year from unilateral refractory neuropathic pain: hemi-body, upper limb, lower limb and facial chronic pain.
• Patient whose analgesic treatment, is stable for at least 1 month.
• Patient not responding to conventional treatments
• Prescreening EVN >3

Exclusion criteria

• History of drug addiction, epilepsy, cranial trauma
• History of psychiatric disorder
• Patients previously treated with rTMS
• Patient with intracranial ferromagnetic material or implanted stimulator
• New treatment for less than one month
• Pregnant or Breastfeeding woman
• Patient who does not understand the study protocol
• Persons who are protected under the act.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

Classic rTMS Stimulation using the B65 Coil

Experimental group

Treatment:

Device: RepetitiveTranscranial Magnetic Stimulation (rTMS)

Deeper rTMS Stimulation using the B70 Coil

Experimental group

Treatment:

Device: RepetitiveTranscranial Magnetic Stimulation (rTMS)

control group with a sham stimulation using a sham coil

Sham Comparator group

Treatment:

Device: RepetitiveTranscranial Magnetic Stimulation (rTMS)