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The purpose of this study is to compare the analgesic effectiveness of two motor cortex neurostimulations (tDCS and rTMS) and the trans-spinal neurostimulation (tsDCS ) in the algoneurodystrophy.
Throughout their participation in the study, patients will complete their VNS report book (1month of baseline before the treatment, 3 months during neurostimulation, 1 month after neurostimulation).
Patients will have 5 evaluation examinations:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS (repetitive transcranial magnetic stimulation) | Experimental | rTMS (repetitive transcranial magnetic stimulation) |
|
| tDCS (transcranial direct-current stimulation) | Experimental | tDCS (transcranial direct-current stimulation) |
|
| tsDCS (transcutaneous spinal Direct Current Stimulation) | Experimental | tsDCS (transcutaneous spinal Direct Current Stimulation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Device |
| ||
| tDCS |
| Measure | Description | Time Frame |
|---|---|---|
| The Visual numeric scale of pain between the three groups | Baseline to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| The Clinical Global Impression scale (CGI) between the three groups | Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180) | |
| The SF12 quality of life questionnaire between the three groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de la douleur, CHU Grenoble Alpes | Grenoble | Isere | 38043 | France | ||
| Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17101886 | Background | Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Keravel Y, Nguyen JP. Motor cortex rTMS restores defective intracortical inhibition in chronic neuropathic pain. Neurology. 2006 Nov 14;67(9):1568-74. doi: 10.1212/01.wnl.0000242731.10074.3c. | |
| 21146300 | Background | de Andrade DC, Mhalla A, Adam F, Texeira MJ, Bouhassira D. Neuropharmacological basis of rTMS-induced analgesia: the role of endogenous opioids. Pain. 2011 Feb;152(2):320-326. doi: 10.1016/j.pain.2010.10.032. Epub 2010 Dec 10. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| tsDCS | Device |
|
| Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180) |
| The Hospital Anxiety and Depression scale (HAD) between the three groups | Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180) |
| The Neuropathic Pain Symptom Inventory scale (NPSI) between the three groups | Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180) |
| Evolution of the conductance of feet and hands by using Sudoscan | The body conductance will be used to assess the evolution of the Impact of the neurostimulation on the sympathetic nervous system and on the small fiber neuropathy. | Baseline, 3 months after the beginning of the treatment (day 90), and 1 month after the end of the treatment (Day 180) |
| Modifications of the sensori-motor cortical cards by using a MRI | Baseline, and 1 month after the end of the treatment (Day 180) |
| Créteil |
| Île-de-France Region |
| 94010 |
| France |
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| Background | Lefaucheur, J. P. (2007). |
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| 25979838 | Background | Hodaj H, Alibeu JP, Payen JF, Lefaucheur JP. Treatment of Chronic Facial Pain Including Cluster Headache by Repetitive Transcranial Magnetic Stimulation of the Motor Cortex With Maintenance Sessions: A Naturalistic Study. Brain Stimul. 2015 Jul-Aug;8(4):801-7. doi: 10.1016/j.brs.2015.01.416. Epub 2015 Feb 7. |
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| 19833552 | Background | Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. |
| 20430702 | Background | Picarelli H, Teixeira MJ, de Andrade DC, Myczkowski ML, Luvisotto TB, Yeng LT, Fonoff ET, Pridmore S, Marcolin MA. Repetitive transcranial magnetic stimulation is efficacious as an add-on to pharmacological therapy in complex regional pain syndrome (CRPS) type I. J Pain. 2010 Nov;11(11):1203-10. doi: 10.1016/j.jpain.2010.02.006. Epub 2010 Apr 28. |
| Background | M. Sorel, J.-P. Lefaucheur, J.-C. Beatrix, A.M. Domec, M.L. Giboutet, E. Houy, J. Robert, P. Cesaro (2012); Complex regional pain syndrome: interest in coupling the vascular phase of technetium 99 bone scintigraphy with the effectiveness of ketamine. Lett. Méd. Phys. Réadapt., OI 10.1007/s11659-012-0296-1 |
| 37589642 | Result | Delon-Martin C, Lefaucheur JP, Hodaj E, Sorel M, Dumolard A, Payen JF, Hodaj H. Neural Correlates of Pain-Autonomic Coupling in Patients With Complex Regional Pain Syndrome Treated by Repetitive Transcranial Magnetic Stimulation of the Motor Cortex. Neuromodulation. 2024 Jan;27(1):188-199. doi: 10.1016/j.neurom.2023.05.005. Epub 2023 Aug 16. |
| 40223918 | Result | Lefaucheur JP, Delon-Martin C, Hodaj H. Functional coupling between chronic pain and the autonomic nervous system revealed by neuromodulation techniques. Comment on 'Effect of neuromodulation for chronic pain on the autonomic nervous system: a systematic review' (BJA Open 2024; 11: 100305). BJA Open. 2025 Mar 29;14:100393. doi: 10.1016/j.bjao.2025.100393. eCollection 2025 Jun. No abstract available. |
| 37545548 | Result | Hodaj H, Payen JF, Hodaj E, Sorel M, Dumolard A, Vercueil L, Delon-Martin C, Lefaucheur JP. Long-term analgesic effect of trans-spinal direct current stimulation compared to non-invasive motor cortex stimulation in complex regional pain syndrome. Brain Commun. 2023 Jul 1;5(4):fcad191. doi: 10.1093/braincomms/fcad191. eCollection 2023. |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |