Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| AOM 120141 | Other Identifier | APHP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to evaluate the long term efficacy over 25 weeks of repeated sessions of magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain intensity, quality of life, sleep, neuropathic symptoms, return to work, in patients with peripheral neuropathic pain.
The medical device of study: transcranial magnetic stimulator (TMS).
The present multicenter parallel session randomized placebo controlled study (4 French centers) aims to evaluate the long term efficacy over 25 weeks of repeated sessions of magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain intensity (primary outcome) and several secondary outcome measures (e.g. quality of life, sleep, neuropathic symptoms, return to work), in patients with peripheral neuropathic pain.
The patients will be randomized to receive one of 3 treatment arms : rTMS of the motor cortex, rTMS of the prefrontal cortex, or placebo (sham stimulation) of the motor or prefrontal cortex. The study will be double blind, eg the patient and the investigator will not know the nature of treatment. the stimulation protocol will consist of an induction phasse of 5 daily sessions then a maintenance phase of several sessions : 3 sessions a week apart, 3 sessions a fortnight apart, and 3 sessions 3 weeks apart. The statistical analysis will be conducted in the intent to treat population and using a modified ITT analysis excluding all the patients with protocol violation (primary outcome). The per protocol population will also be assessed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS of the motor cortex (Magventure) | Experimental | experimental : rTMS of the motor cortex : repetitive magnetic stimulation targeting the motor cortex assisted by neuronavigation |
|
| rTMS placebo (magventure) | Placebo Comparator | sham stimulation of the motor or prefrontal cortex with the placebo face of the device |
|
| rTMS prefrontal cortex (magventure) | Experimental | Experimental : repetitive transcranial stimulation targeting the prefrontal cortex as indicated by neuronavigation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS of prefrontal or motor cortex | Device | description:rTMS of the motor or prefrontal cortex (repetitive magnetic stimulation targeting the motor or prefrontal cortex) assisted with neuronavigation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average pain intensity from baseline to week 25 | Change in average pain intensity from baseline to week 25, average pain intensity corresponds to average pain over the last 24 hours on the Brief Pain Inventory | each visit for up to 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in minimal pain intensity over the last 24 hours from baseline to week 25 | change in minimal pain over the last 24 hours on the Brief Pain inventory | each visit for up 25 weeks |
| quality of life assessment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| NADINE ATTAL, MD, PhD | Pain evaluation and treatment center, CHU A Paré, 92104 Boulogne Billancourt, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain evaluation and treatement center, CHU Ambroise Paré | Boulogne-Billancourt | Hauts-de-Seine | 92106 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38875120 | Derived | Attal N, Branders S, Pereira A, Bouhassira D. Prediction of the response to repetitive transcranial magnetic stimulation of the motor cortex in peripheral neuropathic pain and validation of a new algorithm. Pain. 2025 Jan 1;166(1):34-41. doi: 10.1097/j.pain.0000000000003297. Epub 2024 Jun 14. | |
| 34196698 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
quality of life on the Eurogol questionnaire
| each visit up to 25 weeks |
| Proportion of responders to rTMS | Proportion of responders (patients whose pain is improved by at least 30% and 50% compared to their pain before treatment | at the end of treatment (25 weeks) |
| Predictors of the response | Evaluation of predictors of response (nature of neuropathic symptoms, severity of anxiety or depressive symptoms, presence or absence of mechanical allodynia, or dramatization importance of catastrophism related to pain) | Baseline |
| Safety evaluation | Collection of side effects at each session and between sessions of rTMS | each follow up visit for up to 25 weeks |
| Onset of the analgesic effect of rTMS | Determine the onset of the analgesic effect based on patient pain diaries for up to 1 month | one mont afer the beginning of rTMS |
| Return to work | Return to work on a specific questionnaire at the end of the study | 25 weeks |
| Maximal pain | Maximal pain over the past 24 hours on the Brief Pain Inventory | each visit up to 25 weeks |
| Pain right now | Pain right now immediately after each rtMS session and between sessions for up to 25 weeks | each visit up to 25 weeks |
| Sleep | sleep quality and quantity on MOS sleep | each visit up to 25 weeks |
| Neuropathic symptoms | Neuropathic symptoms on the Neuropathic Pain Symptom Inventory | each visit up to 25 weeks |
| Attal N, Poindessous-Jazat F, De Chauvigny E, Quesada C, Mhalla A, Ayache SS, Fermanian C, Nizard J, Peyron R, Lefaucheur JP, Bouhassira D. Repetitive transcranial magnetic stimulation for neuropathic pain: a randomized multicentre sham-controlled trial. Brain. 2021 Dec 16;144(11):3328-3339. doi: 10.1093/brain/awab208. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |