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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2023-A01346-39 |
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High-frequency repetitive transcranial magnetic stimulation of the primary motor cortex has shown its effect on refractory neuropathic pain, and rTMS of the dorsolateral prefrontal cortex is commonly used for treatment-resistant depression.
The treatment for patients suffering from neuropathic pain and depression, concomitantly, still needs to be studied, as there are some specificities in both symptoms and brain functional MRI.
This project is a cross-over study for these patients, including 4 sessions of either M1 or DLPFC rTMS, a wash-out period, followed by 4 sessions of the other stimulation site, to assess the efficiency of a DLPFC rTMS for neuropathic pain with a comorbid depression. Besides pain intensity and quality, patient's mood, quality of life, and catastrophizing will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M1 - DLPFC | Other | Initial primary motor cortex stimulation (M1) followed by cortex prefrontal cortex (DLPFC) : rTMS of M1, washout, rTMS of DLPFC |
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| DLPFC - M1 | Other | Initial cortex prefrontal cortex (DLPFC) stimulation followed by primary motor cortex stimulation (M1) : rTMS of DLPFC, washout, rTMS of M1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFC | Device | Repetitive transcranial magnetic stimulation (rTMS) is a treatment technique involving the induction of an electrical current on the surface of the cortex by applying a magnetic field to the scalp. This field is generated using a stimulation loop controlled by a robotic arm linked to a neuronavigation system. rTMS of M1 then rTMS of DLPFC. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of pain relief rates between the two stimulation targets (M1 and DLPFC) | Patients are asked how much pain relief they have experienced since the last session. | 2 weeks after the last rTMS session for each arm |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic dimension | Neuropathic dimension: overall score of the Neuropathic Pain Symptoms Inventory (NPSI) questionnaire and its dominant sub-score. The dominant being defined as the score of the dimension (e.g. allodynia, burning, dysesthesia) most painful at the inclusion visit (S0).This questionnaire is used to assess the presence and evolution of neuropathic pain symptoms, as well as the effectiveness of specific neuropathic pain treatments. Based on questioning, it comprises 12 questions (10 descriptive of symptoms and and 2 to assess pain frequency and duration). Score is from 0 ((no pain) to 120 (maximun pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roland PEYRON, PhD | Contact | (0)4 77 12 78 05 | +33 | roland.peyron@univ-st-etienne.fr |
| Hélène RAINGARD, CRA | Contact | helene.raingard@chu-st-etienne.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Recruiting | Saint-Etienne | 42055 | France |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1 | Device | Repetitive transcranial magnetic stimulation (rTMS) is a treatment technique involving the induction of an electrical current on the surface of the cortex by applying a magnetic field to the scalp. This field is generated using a stimulation loop controlled by a robotic arm linked to a neuronavigation system. rTMS of DLPFC then rTMS of M1. |
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| Up to 26 weeks |
| Pain evolution | Pain evolution via multiple Visual Analogue Scale (components: intensity, unpleasantness, impact on on attention). (Minimum Value : 0 means "no pain" - Maximum value : 10 means "the most intense pain imaginable"). | Up to 26 weeks |
| Progression of depression (Montgomery Asberg Depression Rating Scale - MADRS) | Progression of depression (thymia), assessed by subjective percentage improvement in mood by the MADRS. Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items to be completed during a clinical interview. Each item has a severity scale from 0 to 6, with higher scores reflecting more severe symptoms. Scores can be added together to give an overall score (from 0 to 60). | 2 weeks after rTMS sessions |
| Progression of depression (Beck Depression Inventory - BDI) | Progression of depression (thymia), assessed by subjective percentage improvement in mood by the Beck Depression Inventory (BDI). It provides a quantitative estimate of depression intensity. Each item consists of 4 sentences corresponding to 4 degrees of increasing intensity on a scale from 0 to 3. The overall score for the depressive syndrome (from 0 to 39) is obtained by adding up the scores for the 13 items. | 2 weeks after rTMS sessions |
| Changes in mean pain intensity | Comparison of changes in mean pain intensity between the two treatment arms by using Visual Analogue Scale (components: intensity, unpleasantness, impact on on attention). (Minimum Value : 0 means "no pain" - Maximum value : 10 means "the most intense pain imaginable"). | 2 weeks after rTMS sessions |
| Evolution of catastrophism | Evolution of catastrophism via the Pain Catastrophizing Scale. People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness. | 2 weeks after rTMS sessions |
| Evolution of affective and sensory components of pain | Evolution of affective and sensory components of pain via the Pain Questionnaire Saint-Antoine (QDSA). This questionnaire contains 58 words divided into 16 categories offering dimensions that to describe the painful experience | 2 weeks after rTMS sessions |
| Change in perceived quality of life | Change in perceived quality of life using the EuroQol-5D (EQ5-D). The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). | 2 weeks after rTMS sessions |
| Adverse events | Potential adverse events reporting during the study | Up to 26 weeks |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |