Clinical trial NCT04936646: Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,
Official title: Randomized Double-blind Study of RTMS Analgesic Effect in Chronic Neuropathic Pain. Comparison Between Three Groups: Motor Cortex Stimulation by the Classic Coil B65, Deeper Stimulation by the Coil B70 and Placebo Stimulation. Analysis of Long-term RTMS-induced Brain Changes Using FMRI.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Neuropathic Pain
Keywords: rTMS
Chronic neuropathic pain
Repetitive Transcranial Magnetic Stimulation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evolution of Pain.
timeFrame: Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)
Secondary outcomes:
measure: Assesment of Potential Changes in Sensory-motor Cortical Maps Induced by rTMS
timeFrame: Day 60 from the beginning of rTMS treatment compared to baseline.
measure: Rate of Responding Patients.
timeFrame: week 7 compared with baseline
measure: Assessment of Overall Patient Improvement.
timeFrame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
measure: Quality of Life Improvement.
timeFrame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
measure: Evolution of Anxiety and Depressive Traits.
timeFrame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
measure: Evolution of Symptomatological Profiles of Neuropathic Pain.
timeFrame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.
measure: Sympathetic Autonomic System Injury and Small Fiber Neuropathy.
timeFrame: Day 60 from the beginning of rTMS treatment compared to baseline.
measure: Autonomous System Assessement.
timeFrame: Day 60 from the beginning of rTMS treatment compared to baseline.
measure: Evolution of the use of analgesic treatments.
timeFrame: From baseline to day 60.
measure: Analgesic Response Analysis
timeFrame: From baseline to day 60.
measure: Improvement of pain triggered by a stimulus (allodynia).
timeFrame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Centre de la douleur, CHU Grenoble Alpes
state: Isère
Study officials:
affiliation: CHUGA
name: Hasan HODAJ, MD
role: PRINCIPAL_INVESTIGATOR
References: