Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RepetitiveTranscranial Magnetic Stimulation (rTMS).
- Who it may be relevant to
- Registry conditions: Chronic Neuropathic Pain. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Device RepetitiveTranscranial Magnetic Stimulation (rTMS)
The rTMS protocol consist of one session per day for five days during the first week, then three sessions the second week and then one session the third week, followed by two monthly sessions.
Primary outcome measures
- Evolution of Pain. [Time frame: Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)]
Secondary outcome measures (11)
- Assesment of Potential Changes in Sensory-motor Cortical Maps Induced by rTMS [Time frame: Day 60 from the beginning of rTMS treatment compared to baseline.]
- Rate of Responding Patients. [Time frame: week 7 compared with baseline]
- Assessment of Overall Patient Improvement. [Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline]
- Quality of Life Improvement. [Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline]
- Evolution of Anxiety and Depressive Traits. [Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline]
- Evolution of Symptomatological Profiles of Neuropathic Pain. [Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.]
- Sympathetic Autonomic System Injury and Small Fiber Neuropathy. [Time frame: Day 60 from the beginning of rTMS treatment compared to baseline.]
- Autonomous System Assessement. [Time frame: Day 60 from the beginning of rTMS treatment compared to baseline.]
- Evolution of the use of analgesic treatments. [Time frame: From baseline to day 60.]
- Analgesic Response Analysis [Time frame: From baseline to day 60.]
- Improvement of pain triggered by a stimulus (allodynia). [Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Centre de la douleur, CHU Grenoble Alpes — Grenoble
Identifiers
NCT: NCT04936646 · 38RC20192