Comparison of the Analgesic Effect Between the Motor Cortex Stimulation and the Trans-spinal Stimulation in the Algoneurodystrophy.
NCT ID: NCT02817880
Last Updated: 2025-12-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
36 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-07-25
Study Completion Date
2022-02-22
Brief Summary
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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.
Detailed Description
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* Entry into the study : After informed consent, patients will be randomised into three groups : tDCS, rTMS, tsDCS. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS).
* Baseline : Participants, will record on a book, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 month.
* The beginning of the treatment : after the baseline, sessions of neurostimulation will begin. Sessions of neurostimulation will have a decreasing rhythm. Five sessions per week during the two first weeks, two sessions per week during the third week, one session during the fourth week and then two sessions per month for four months.
* After the end of neurostimulation sessions, patients will be followed for 1month.
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:
* The first, one just before the beginning of the neurostimulation,
* The second, 1 month after the beginning of neurostimulation
* The third, 3 months after the beginning of neurostimulation
* And the last one, 1 month after the end of neurostimulation.
* Baseline : Participants, will record on a book, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 month.
* The beginning of the treatment : after the baseline, sessions of neurostimulation will begin. Sessions of neurostimulation will have a decreasing rhythm. Five sessions per week during the two first weeks, two sessions per week during the third week, one session during the fourth week and then two sessions per month for four months.
* After the end of neurostimulation sessions, patients will be followed for 1month.
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:
* The first, one just before the beginning of the neurostimulation,
* The second, 1 month after the beginning of neurostimulation
* The third, 3 months after the beginning of neurostimulation
* And the last one, 1 month after the end of neurostimulation.
Conditions
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Algoneurodystrophy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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rTMS (repetitive transcranial magnetic stimulation)
rTMS (repetitive transcranial magnetic stimulation)
Group Type
EXPERIMENTAL
rTMS
Intervention Type
DEVICE
tDCS (transcranial direct-current stimulation)
tDCS (transcranial direct-current stimulation)
Group Type
EXPERIMENTAL
tDCS
Intervention Type
DEVICE
tsDCS (transcutaneous spinal Direct Current Stimulation)
tsDCS (transcutaneous spinal Direct Current Stimulation)
Group Type
EXPERIMENTAL
tsDCS
Intervention Type
DEVICE
Interventions
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rTMS
Intervention Type
DEVICE
tDCS
Intervention Type
DEVICE
tsDCS
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Patient's written consent
* Patient suffering from an algoneurodystrophy for more than a year.
* Diagnosis of algoneurodystrophy confirmed by an osseous scintigraphy
* Stable treatment for at least 1 month
* Patient non-responsive to pharmacological treatments
* VNS \> 3 at the time of screening
* Patient suffering from an algoneurodystrophy for more than a year.
* Diagnosis of algoneurodystrophy confirmed by an osseous scintigraphy
* Stable treatment for at least 1 month
* Patient non-responsive to pharmacological treatments
* VNS \> 3 at the time of screening
Exclusion Criteria
* Drug addiction
* History of epilepsy, head trauma, Psychiatric pathology likely to hamper the progress of the study.
* Intracranial ferromagnetic material or an implanted stimulator
* MRI contraindication
* Algoneurodystrophy due to a nervous lesion
* Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
* History of epilepsy, head trauma, Psychiatric pathology likely to hamper the progress of the study.
* Intracranial ferromagnetic material or an implanted stimulator
* MRI contraindication
* Algoneurodystrophy due to a nervous lesion
* Pregnant women, parturient women, breast-feeding mother. Lack of effective contraception
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Grenoble
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Centre de la douleur, CHU Grenoble Alpes
Grenoble, Isere, France
Site Status
Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor
Créteil, Île-de-France Region, France
Site Status
Countries
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France
References
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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
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Lefaucheur JP, Andre-Obadia N, Poulet E, Devanne H, Haffen E, Londero A, Cretin B, Leroi AM, Radtchenko A, Saba G, Thai-Van H, Litre CF, Vercueil L, Bouhassira D, Ayache SS, Farhat WH, Zouari HG, Mylius V, Nicolier M, Garcia-Larrea L. [French guidelines on the use of repetitive transcranial magnetic stimulation (rTMS): safety and therapeutic indications]. Neurophysiol Clin. 2011 Dec;41(5-6):221-95. doi: 10.1016/j.neucli.2011.10.062. Epub 2011 Nov 10. French.
Reference Type
BACKGROUND
Lefaucheur JP, Menard-Lefaucheur I, Goujon C, Keravel Y, Nguyen JP. Predictive value of rTMS in the identification of responders to epidural motor cortex stimulation therapy for pain. J Pain. 2011 Oct;12(10):1102-11. doi: 10.1016/j.jpain.2011.05.004. Epub 2011 Jul 31.
Reference Type
BACKGROUND
Lefaucheur, J. P. (2007).
Reference Type
BACKGROUND
Khedr EM, Kotb H, Kamel NF, Ahmed MA, Sadek R, Rothwell JC. Longlasting antalgic effects of daily sessions of repetitive transcranial magnetic stimulation in central and peripheral neuropathic pain. J Neurol Neurosurg Psychiatry. 2005 Jun;76(6):833-8. doi: 10.1136/jnnp.2004.055806.
Reference Type
BACKGROUND
Passard A, Attal N, Benadhira R, Brasseur L, Saba G, Sichere P, Perrot S, Januel D, Bouhassira D. Effects of unilateral repetitive transcranial magnetic stimulation of the motor cortex on chronic widespread pain in fibromyalgia. Brain. 2007 Oct;130(Pt 10):2661-70. doi: 10.1093/brain/awm189. Epub 2007 Sep 14.
Reference Type
BACKGROUND
Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.
Reference Type
BACKGROUND
Leung A, Donohue M, Xu R, Lee R, Lefaucheur JP, Khedr EM, Saitoh Y, Andre-Obadia N, Rollnik J, Wallace M, Chen R. rTMS for suppressing neuropathic pain: a meta-analysis. J Pain. 2009 Dec;10(12):1205-16. doi: 10.1016/j.jpain.2009.03.010. Epub 2009 May 23.
Reference Type
BACKGROUND
Lefaucheur JP. Use of repetitive transcranial magnetic stimulation in pain relief. Expert Rev Neurother. 2008 May;8(5):799-808. doi: 10.1586/14737175.8.5.799.
Reference Type
BACKGROUND
Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.
Reference Type
BACKGROUND
Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.
Reference Type
BACKGROUND
Medeiros LF, de Souza IC, Vidor LP, de Souza A, Deitos A, Volz MS, Fregni F, Caumo W, Torres IL. Neurobiological effects of transcranial direct current stimulation: a review. Front Psychiatry. 2012 Dec 28;3:110. doi: 10.3389/fpsyt.2012.00110. eCollection 2012.
Reference Type
BACKGROUND
Thibaut A, Chatelle C, Gosseries O, Laureys S, Bruno MA. [Transcranial direct current stimulation: a new tool for neurostimulation]. Rev Neurol (Paris). 2013 Feb;169(2):108-20. doi: 10.1016/j.neurol.2012.05.008. Epub 2012 Sep 7. French.
Reference Type
BACKGROUND
Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum. 2006 Dec;54(12):3988-98. doi: 10.1002/art.22195.
Reference Type
BACKGROUND
Antal A, Kriener N, Lang N, Boros K, Paulus W. Cathodal transcranial direct current stimulation of the visual cortex in the prophylactic treatment of migraine. Cephalalgia. 2011 May;31(7):820-8. doi: 10.1177/0333102411399349. Epub 2011 Mar 11.
Reference Type
BACKGROUND
Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.
Reference Type
BACKGROUND
Mori F, Codeca C, Kusayanagi H, Monteleone F, Buttari F, Fiore S, Bernardi G, Koch G, Centonze D. Effects of anodal transcranial direct current stimulation on chronic neuropathic pain in patients with multiple sclerosis. J Pain. 2010 May;11(5):436-42. doi: 10.1016/j.jpain.2009.08.011. Epub 2009 Dec 16.
Reference Type
BACKGROUND
Antal A, Terney D, Kuhnl S, Paulus W. Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. J Pain Symptom Manage. 2010 May;39(5):890-903. doi: 10.1016/j.jpainsymman.2009.09.023.
Reference Type
BACKGROUND
O'Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain stimulation techniques for chronic pain. A report of a Cochrane systematic review and meta-analysis. Eur J Phys Rehabil Med. 2011 Jun;47(2):309-26. Epub 2011 Apr 14.
Reference Type
BACKGROUND
Zaghi S, Thiele B, Pimentel D, Pimentel T, Fregni F. Assessment and treatment of pain with non-invasive cortical stimulation. Restor Neurol Neurosci. 2011;29(6):439-51. doi: 10.3233/RNN-2011-0615.
Reference Type
BACKGROUND
Luedtke K, Rushton A, Wright C, Geiss B, Juergens TP, May A. Transcranial direct current stimulation for the reduction of clinical and experimentally induced pain: a systematic review and meta-analysis. Clin J Pain. 2012 Jun;28(5):452-61. doi: 10.1097/AJP.0b013e31823853e3.
Reference Type
BACKGROUND
O'Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2014 Apr 11;(4):CD008208. doi: 10.1002/14651858.CD008208.pub3.
Reference Type
BACKGROUND
Cogiamanian F, Vergari M, Pulecchi F, Marceglia S, Priori A. Effect of spinal transcutaneous direct current stimulation on somatosensory evoked potentials in humans. Clin Neurophysiol. 2008 Nov;119(11):2636-40. doi: 10.1016/j.clinph.2008.07.249. Epub 2008 Sep 10.
Reference Type
BACKGROUND
Truini A, Vergari M, Biasiotta A, La Cesa S, Gabriele M, Di Stefano G, Cambieri C, Cruccu G, Inghilleri M, Priori A. Transcutaneous spinal direct current stimulation inhibits nociceptive spinal pathway conduction and increases pain tolerance in humans. Eur J Pain. 2011 Nov;15(10):1023-7. doi: 10.1016/j.ejpain.2011.04.009. Epub 2011 May 14.
Reference Type
BACKGROUND
Toshev PK, Guleyupoglu B, Bikson M. Informing dose design by modeling transcutaneous spinal direct current stimulation. Clin Neurophysiol. 2014 Nov;125(11):2147-2149. doi: 10.1016/j.clinph.2014.03.022. Epub 2014 Apr 4. No abstract available.
Reference Type
BACKGROUND
Priori A, Ciocca M, Parazzini M, Vergari M, Ferrucci R. Transcranial cerebellar direct current stimulation and transcutaneous spinal cord direct current stimulation as innovative tools for neuroscientists. J Physiol. 2014 Aug 15;592(16):3345-69. doi: 10.1113/jphysiol.2013.270280. Epub 2014 Jun 6.
Reference Type
BACKGROUND
Cogiamanian F, Ardolino G, Vergari M, Ferrucci R, Ciocca M, Scelzo E, Barbieri S, Priori A. Transcutaneous spinal direct current stimulation. Front Psychiatry. 2012 Jul 4;3:63. doi: 10.3389/fpsyt.2012.00063. eCollection 2012.
Reference Type
BACKGROUND
Plow EB, Pascual-Leone A, Machado A. Brain stimulation in the treatment of chronic neuropathic and non-cancerous pain. J Pain. 2012 May;13(5):411-24. doi: 10.1016/j.jpain.2012.02.001. Epub 2012 Apr 7.
Reference Type
BACKGROUND
Lefaucheur JP, Antal A, Ahdab R, Ciampi de Andrade D, Fregni F, Khedr EM, Nitsche M, Paulus W. The use of repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) to relieve pain. Brain Stimul. 2008 Oct;1(4):337-44. doi: 10.1016/j.brs.2008.07.003. Epub 2008 Oct 7.
Reference Type
BACKGROUND
Fregni F, Freedman S, Pascual-Leone A. Recent advances in the treatment of chronic pain with non-invasive brain stimulation techniques. Lancet Neurol. 2007 Feb;6(2):188-91. doi: 10.1016/S1474-4422(07)70032-7.
Reference Type
BACKGROUND
Nizard J, Lefaucheur JP, Helbert M, de Chauvigny E, Nguyen JP. Non-invasive stimulation therapies for the treatment of refractory pain. Discov Med. 2012 Jul;14(74):21-31.
Reference Type
BACKGROUND
Mhalla A, Baudic S, de Andrade DC, Gautron M, Perrot S, Teixeira MJ, Attal N, Bouhassira D. Long-term maintenance of the analgesic effects of transcranial magnetic stimulation in fibromyalgia. Pain. 2011 Jul;152(7):1478-1485. doi: 10.1016/j.pain.2011.01.034. Epub 2011 Mar 11.
Reference Type
BACKGROUND
Zaghi S, DaSilva AF, Acar M, Lopes M, Fregni F. One-year rTMS treatment for refractory trigeminal neuralgia. J Pain Symptom Manage. 2009 Oct;38(4):e1-5. doi: 10.1016/j.jpainsymman.2009.04.020. Epub 2009 Aug 26. No abstract available.
Reference Type
BACKGROUND
Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Nguyen JP. Neuropathic pain controlled for more than a year by monthly sessions of repetitive transcranial magnetic stimulation of the motor cortex. Neurophysiol Clin. 2004 Apr;34(2):91-5. doi: 10.1016/j.neucli.2004.02.001.
Reference Type
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.
Reference Type
BACKGROUND
Kim YJ, Ku J, Kim HJ, Im DJ, Lee HS, Han KA, Kang YJ. Randomized, sham controlled trial of transcranial direct current stimulation for painful diabetic polyneuropathy. Ann Rehabil Med. 2013 Dec;37(6):766-76. doi: 10.5535/arm.2013.37.6.766. Epub 2013 Dec 23.
Reference Type
BACKGROUND
Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Other Identifiers
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38RC15.158
Identifier Type: -
Identifier Source: org_study_id