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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-A01437-38 | Other Identifier | ID-RCB |
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The primary aim of this study is to evaluate the induction of sensory-motor cortex plasticity after motor cortex stimulation in healthy subjects, using laser-evoked nociceptive cortical potentials, and in chronic neuropathic pain patients using functional MRI. As a secondary goal, the project will analyse possible correlations between the magnitude of cortical plasticity and that of the pain-relieving effect.
In healthy subjects, cortical plasticity is evaluated by the comparison of somatosensory cortical maps before and after two isolated sessions of 20 Hz and theta-burst rTMS, in a cross-over randomized study.
Two sessions of 5 consecutive days of rTMS are proposed to the patients with a minimum of 4 weeks between the two sessions, defined by 20 Hz and theta-burst stimulation in a cross-over randomized order. Cortical plasticity of the motor cortex is evaluated via functional MRI (motor activation) performed before the first rTMS session and the last day of each session of rTMS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy volunteers | Active Comparator |
| |
| Patients with resistant pain | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | 20Hz and Theta Burst stimulation, both at 80% of motor threshold in contralateral intrinsic hand muscles. Five consecutive days of each mode of stimulation, separated by a minimum of 4 weeks. Daily self-monitoring of pain, sleep quality and fatigue by mans of a 10-item questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| cortical plasticity induced by rTMS - - Somatosensory evoked potentials | Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients.
| just before the isolated 20 Hz or theta-burst stimulation for healthy subjects |
| cortical plasticity induced by rTMS - - Somatosensory evoked potentials | Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients.
| just after the isolated 20 Hz or theta-burst stimulation for healthy subjects |
| cortical plasticity induced by rTMS -- fMRI | Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients.
| within 1 week before the first day of stimulation (20 Hz or theta-burst) for the patients |
| cortical plasticity induced by rTMS -- fMRI |
| Measure | Description | Time Frame |
|---|---|---|
| Nonparametric (Chi-2) contrast of dichotomized pain reports before/after rTMS and extent of fMRI activation change (also dichotomized) MRI T1 3D and T2* | within 1 week before the first day of stimulation Stats after 40 patients studied. | |
| Nonparametric (Chi-2) contrast of dichotomized pain reports before/after rTMS and extent of fMRI activation change (also dichotomized) MRI T1 3D and T2* |
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Inclusion Criteria:
healthy subjects aged from 18 to 70 years, male or female, with social protection, fully informed and having given their written consent.
patients :
Exclusion Criteria:
For patients only: new analgesic treatment within 1 month before consent
for both:
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie ANDRE-OBADIA, MD | Service d'Exploration, Centre Hospitalier Lyon Est, Hospices civils de Lyon, Lyon, F-69495, France et NeuroPain lab - CRNL (Inserm U1028 - UCBL) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Exploration, Centre Hospitalier Lyon Est, Hospices civils de Lyon, Lyon, F-69495, France et NeuroPain lab - CRNL (Inserm U1028 - UCBL) | Bron | 69500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36266501 | Result | Andre-Obadia N, Hodaj H, Hodaj E, Simon E, Delon-Martin C, Garcia-Larrea L. Better Fields or Currents? A Head-to-Head Comparison of Transcranial Magnetic (rTMS) Versus Direct Current Stimulation (tDCS) for Neuropathic Pain. Neurotherapeutics. 2023 Jan;20(1):207-219. doi: 10.1007/s13311-022-01303-x. Epub 2022 Oct 20. |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| 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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|
Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients.
|
| after the 5th day of stimulation (20 Hz or theta-burst) for the patients |
| after the 5th day of stimulation. Stats after 40 patients studied. |
| Linear and nonlinear correlation between the magnitude of induced cortical plasticity and the magnitude of pain relief induced by rTMS. MRI T1 3D and T2*, | within 1 week before the first day of stimulation Stats after 40 patients studied. |
| Linear and nonlinear correlation between the magnitude of induced cortical plasticity and the magnitude of pain relief induced by rTMS. MRI T1 3D and T2*, | after the 5th day of stimulation. Stats after 40 patients studied. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |