Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01195-42 | Other Identifier | ANSM |
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS - Sham | Experimental | 5 stimulation sessions on M1 - washout 8 weeks - 5 sham stimulation sessions (placebo-control, same site, inactive stimulation) |
|
| Sham - Active rTMS | Experimental | 5 sham stimulation sessions (placebo-control, same site, inactive stimulation) - washout 8 weeks - 5 stimulation sessions on M1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS) - active | Device | rTMS session active on the primary motor cortex |
|
| Measure | Description | Time Frame |
|---|---|---|
| PAIN RELIEF | PAIN from 0% : no pain relief at all to 100%: completely relief. | Week 7 after the start of RTMs stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity with Visual analog scale (VAS) | 0 no pain to 10 extremely pain | day 7 post RTMs stimulation |
| score of Neuropathic Pain Symptom Inventory - NPSI | [0= zero neuropatthic pain to 100= maximum neuropathic pain] |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roland PEYRON, PhD | Contact | 0477824095 | 33 | roland.peyron@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Roland PEYRON, PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PEYRON Roland | Recruiting | Saint-Etienne | 42055 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
| Repetitive transcranial magnetic stimulation (rTMS) - inactive | Device | rTMS session inactive on the primary motor cortex |
|
| day 7 post RTMs stimulation |
| Brief Pain Inventory - BPI | 1 - 4 = Mild Pain. 5 =Worst Pain Score 6 = Moderate Pain. 7=Worst Pain Score 10 = Severe Pain. | day 7 post RTMs stimulation |
| Pain relief | scale ranging from 0% = no relief to 100% = fully relieved | day 7 post RTMs stimulation |
| Visual Analogic Scale VAS on emotional dimension of pain | Visual Analogic Scale VAS (0 = not unpleasant) to 10 = extremely unpleasant) | day 7 post RTMs stimulation |
| Visual Analogic Scale (VAS) on attentional dimension of pain | 0 = does not attract at all to 10 = completely attracts | day 7 post RTMs stimulation |
| consumption of rescue analgesics | Week 7 after the start of RTMs stimlulation |
| Effect of rTMS on quality of life | Quality of life score (EQ-5D) from 0 to 100. 100 corresponds to the best health. | Week 7 after the start of RTMs stimlulation |
| HADS: Hospital Anxiety and Depression Scale | from 0 to 14: no anxiety disorders; from 15 to 42: existence of anxiety disorders. | Week 7 after the start of RTMs stimlulation |
| Tolerance | Tolerance will be defined as the absence of adverse effects throughout the duration of the protocol, as reported in systematic questionnaires." | week 7 after the start of RTMs stimulation |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
Not provided
Not provided