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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-06-30
Study Completion Date
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Prevalence of neuropathic pain raise to 6.9 % in the general population and can reach more than 58 % for patients that carry a lesion of the spinal cord. This pathological condition stays a major health problem, particularly as the efficacity of available treatments is currently limited. Only 30 to 40% of patients are relieved of more than 50% of their pain by a pharmacological approach.
In case of failure, drug treatments or in addition of these ones, stimulation of the motor cortex is a therapeutic path proposed by Tsubokawa since the beginning of 1990s, but that found its place for neuropathic drug-resistant pain management only since a decade. Neurophysiologic mechanisms of the analgesic efficacity of the motor cortex stimulation are still little understood. This stimulation can be realised in a chronic and invasive way with implanted electrodes. This process allow a lasting relief for about half of operated persons, without the possibility to identify clinical selection criterion reliable for potentially responding patients for this technique.
Recently, two electrophysiological non invasive techniques have been developed, allowing to get an analgesic stimulation of the motor cortex: the repetitive transcranial magnetic stimulation (rTMS) and the direct current transcranial magnetic stimulation (tDCS).
The main goal of this study is to compare the importance of analgesic effect of tDCS in chronic drug-resistant neurophysiologic pains to the one get thanks to a reference method of stimulation non invasive of the motor cortex, the rTMS whose analgesic effect is already validated by data of the literature.
In case of failure, drug treatments or in addition of these ones, stimulation of the motor cortex is a therapeutic path proposed by Tsubokawa since the beginning of 1990s, but that found its place for neuropathic drug-resistant pain management only since a decade. Neurophysiologic mechanisms of the analgesic efficacity of the motor cortex stimulation are still little understood. This stimulation can be realised in a chronic and invasive way with implanted electrodes. This process allow a lasting relief for about half of operated persons, without the possibility to identify clinical selection criterion reliable for potentially responding patients for this technique.
Recently, two electrophysiological non invasive techniques have been developed, allowing to get an analgesic stimulation of the motor cortex: the repetitive transcranial magnetic stimulation (rTMS) and the direct current transcranial magnetic stimulation (tDCS).
The main goal of this study is to compare the importance of analgesic effect of tDCS in chronic drug-resistant neurophysiologic pains to the one get thanks to a reference method of stimulation non invasive of the motor cortex, the rTMS whose analgesic effect is already validated by data of the literature.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Analgesic Effect of Non Invasive Stimulation : Comparison of rTMS and tDCS Efficacy
NCT01800136
Pharmacoresistant Neuropathic Pain
COMPLETED
NA
Comparison of the Efficacy of rTMS and tDCS of the Motor Cortex in Patients With Chronic Neuropathic Pain
NCT02030626
Lumbar Radiculopathy
COMPLETED
PHASE4
Analgesic Effects of rTMS in Peripheral Neuropathic Pain
NCT02010281
Neuropathic Pain
COMPLETED
NA
Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex
NCT03015558
Neuropathic Pain
COMPLETED
NA
Comparison of the Analgesic Effect Between the Motor Cortex Stimulation and the Trans-spinal Stimulation in the Algoneurodystrophy.
NCT02817880
Algoneurodystrophy
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Neuropathic Chronic Pain
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MRI by rTMS
Patients which received an MRI study of cortical plasticity by rTMS.
Group Type
ACTIVE_COMPARATOR
rTMS session
Intervention Type
DEVICE
Repetitive transcranial magnetic stimulation.
MRI by tDCS
Patients which received an MRI study of cortical plasticity by tDCS.
Group Type
ACTIVE_COMPARATOR
tDCS session
Intervention Type
DEVICE
Direct current transcranial magnetic stimulation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
tDCS session
Direct current transcranial magnetic stimulation
Intervention Type
DEVICE
rTMS session
Repetitive transcranial magnetic stimulation.
Intervention Type
DEVICE
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
MRI
MRI
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Persons affiliated to national social security.
* Patients that have given their signed free consent.
* Patients from 18 to 80 years, men or women, carriers of a chronic neuropathic pain (since more than a year ; EVN \> 2during week S0) drug resistant, unilateral, involving at least the superior member and/or hemi-face, whose analgesic treatment is stable from at least one month.
* Patients whose drug resistance conduce their referent Algologist (specialist in pain medicine) to study the possibility to propose them alternative therapeutic solutions nonpharmacological and to start a pre-surgical examination.
* Patients that have given their signed free consent.
* Patients from 18 to 80 years, men or women, carriers of a chronic neuropathic pain (since more than a year ; EVN \> 2during week S0) drug resistant, unilateral, involving at least the superior member and/or hemi-face, whose analgesic treatment is stable from at least one month.
* Patients whose drug resistance conduce their referent Algologist (specialist in pain medicine) to study the possibility to propose them alternative therapeutic solutions nonpharmacological and to start a pre-surgical examination.
Exclusion Criteria
* History of drug addiction, migraine, epilepsy.
* Presence of ferromagnetic intracranial equipment or a stimulating implanted (pace-maker, stimulation of basal ganglia, vagus nerve stimulator).
* Introduction of a new analgesic treatment since at least a month.
* Pregnant, parturient or breastfeeding women. The absence of effective contraception during all the study for patients of childbearing age.
* Persons deprived of liberty by judicial or administrative decision, person under legal protection.
* Counter-argument to MRI.
* Presence of ferromagnetic intracranial equipment or a stimulating implanted (pace-maker, stimulation of basal ganglia, vagus nerve stimulator).
* Introduction of a new analgesic treatment since at least a month.
* Pregnant, parturient or breastfeeding women. The absence of effective contraception during all the study for patients of childbearing age.
* Persons deprived of liberty by judicial or administrative decision, person under legal protection.
* Counter-argument to MRI.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Grenoble
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hasan Hodaj, Doctor
Role: PRINCIPAL_INVESTIGATOR
Grenoble Hospital University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UniversityHospitalGrenoble
La Tronche, , France
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
France
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Andre-Obadia N, Garcia-Larrea L, Garassus P, Mauguiere F. Timing and characteristics of perceptual attenuation by transcranial stimulation: a study using magnetic cortical stimulation and somatosensory-evoked potentials. Psychophysiology. 1999 Jul;36(4):476-83. doi: 10.1017/s0048577299971676.
Reference Type
BACKGROUND
Andre-Obadia N, Mertens P, Gueguen A, Peyron R, Garcia-Larrea L. Pain relief by rTMS: differential effect of current flow but no specific action on pain subtypes. Neurology. 2008 Sep 9;71(11):833-40. doi: 10.1212/01.wnl.0000325481.61471.f0.
Reference Type
BACKGROUND
Andre-Obadia N, Peyron R, Mertens P, Mauguiere F, Laurent B, Garcia-Larrea L. Transcranial magnetic stimulation for pain control. Double-blind study of different frequencies against placebo, and correlation with motor cortex stimulation efficacy. Clin Neurophysiol. 2006 Jul;117(7):1536-44. doi: 10.1016/j.clinph.2006.03.025. Epub 2006 Jun 5.
Reference Type
BACKGROUND
Attal N, Cruccu G, Haanpaa M, Hansson P, Jensen TS, Nurmikko T, Sampaio C, Sindrup S, Wiffen P; EFNS Task Force. EFNS guidelines on pharmacological treatment of neuropathic pain. Eur J Neurol. 2006 Nov;13(11):1153-69. doi: 10.1111/j.1468-1331.2006.01511.x.
Reference Type
BACKGROUND
Barker AT, Freeston IL, Jabinous R, Jarratt JA. Clinical evaluation of conduction time measurements in central motor pathways using magnetic stimulation of human brain. Lancet. 1986 Jun 7;1(8493):1325-6. doi: 10.1016/s0140-6736(86)91243-2. No abstract available.
Reference Type
BACKGROUND
Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.
Reference Type
BACKGROUND
Bouhassira D, Lanteri-Minet M, Attal N, Laurent B, Touboul C. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain. 2008 Jun;136(3):380-387. doi: 10.1016/j.pain.2007.08.013. Epub 2007 Sep 20.
Reference Type
BACKGROUND
Cruccu G, Aziz TZ, Garcia-Larrea L, Hansson P, Jensen TS, Lefaucheur JP, Simpson BA, Taylor RS. EFNS guidelines on neurostimulation therapy for neuropathic pain. Eur J Neurol. 2007 Sep;14(9):952-70. doi: 10.1111/j.1468-1331.2007.01916.x.
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
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
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
Fregni F, Pascual-Leone A. Technology insight: noninvasive brain stimulation in neurology-perspectives on the therapeutic potential of rTMS and tDCS. Nat Clin Pract Neurol. 2007 Jul;3(7):383-93. doi: 10.1038/ncpneuro0530.
Reference Type
BACKGROUND
Garcia-Larrea L, Peyron R. Motor cortex stimulation for neuropathic pain: From phenomenology to mechanisms. Neuroimage. 2007;37 Suppl 1:S71-9. doi: 10.1016/j.neuroimage.2007.05.062. Epub 2007 Jun 29.
Reference Type
BACKGROUND
H. Hodaj, C. Maindet Dominici ,JP. Alibeu. Intérêt de la neuronavigation dans la pratique de la stimulation magnétique transcrânienne repetitive (SMTr) Douleurs, 2011, Vol.12 A77
Reference Type
BACKGROUND
Hodaj H, Alibeu JP, Dominici C, D, Szekely D, Jacquot C. Traitement des douleurs réfractaires de la face par la stimulation magnétique transcranienne répétitive (SMTr) : étude ouverte sur une année Douleurs ; 2010, Vol. 11, 280-287
Reference Type
BACKGROUND
Hodaj H, Pellat J, Szekely D, Alibeu JP, Bougerol T, Jacquot C. Utilisation de la stimulation magnétique transcranienne répétitive(SMTr) dans le traitement de la douleur neuropathique chronique résistante aux thérapeutiques conventionnelles. Douleurs, 2007,8, 1S62
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
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
Leo RJ, Latif T. Repetitive transcranial magnetic stimulation (rTMS) in experimentally induced and chronic neuropathic pain: a review. J Pain. 2007 Jun;8(6):453-9. doi: 10.1016/j.jpain.2007.01.009. Epub 2007 Apr 16.
Reference Type
BACKGROUND
McCann UD, Kimbrell TA, Morgan CM, Anderson T, Geraci M, Benson BE, Wassermann EM, Willis MW, Post RM. Repetitive transcranial magnetic stimulation for posttraumatic stress disorder. Arch Gen Psychiatry. 1998 Mar;55(3):276-9. doi: 10.1001/archpsyc.55.3.276. No abstract available.
Reference Type
BACKGROUND
Mertens P, Nuti C, Sindou M, Guenot M, Peyron R, Garcia-Larrea L, Laurent B. Precentral cortex stimulation for the treatment of central neuropathic pain: results of a prospective study in a 20-patient series. Stereotact Funct Neurosurg. 1999;73(1-4):122-5. doi: 10.1159/000029769.
Reference Type
BACKGROUND
Merzagora AC, Foffani G, Panyavin I, Mordillo-Mateos L, Aguilar J, Onaral B, Oliviero A. Prefrontal hemodynamic changes produced by anodal direct current stimulation. Neuroimage. 2010 Feb 1;49(3):2304-10. doi: 10.1016/j.neuroimage.2009.10.044. Epub 2009 Oct 21.
Reference Type
BACKGROUND
Migita K, Uozumi T, Arita K, Monden S. Transcranial magnetic coil stimulation of motor cortex in patients with central pain. Neurosurgery. 1995 May;36(5):1037-9; discussion 1039-40. doi: 10.1227/00006123-199505000-00025.
Reference Type
BACKGROUND
Nguyen JP, Lefaucheur JP, Decq P, Uchiyama T, Carpentier A, Fontaine D, Brugieres P, Pollin B, Feve A, Rostaing S, Cesaro P, Keravel Y. Chronic motor cortex stimulation in the treatment of central and neuropathic pain. Correlations between clinical, electrophysiological and anatomical data. Pain. 1999 Sep;82(3):245-251. doi: 10.1016/S0304-3959(99)00062-7.
Reference Type
BACKGROUND
Nitsche MA, Fricke K, Henschke U, Schlitterlau A, Liebetanz D, Lang N, Henning S, Tergau F, Paulus W. Pharmacological modulation of cortical excitability shifts induced by transcranial direct current stimulation in humans. J Physiol. 2003 Nov 15;553(Pt 1):293-301. doi: 10.1113/jphysiol.2003.049916. Epub 2003 Aug 29.
Reference Type
BACKGROUND
Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
Reference Type
BACKGROUND
Nuti C, Peyron R, Garcia-Larrea L, Brunon J, Laurent B, Sindou M, Mertens P. Motor cortex stimulation for refractory neuropathic pain: four year outcome and predictors of efficacy. Pain. 2005 Nov;118(1-2):43-52. doi: 10.1016/j.pain.2005.07.020. Epub 2005 Oct 7.
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
Pascual-Leone A, Catala MD, Pascual-Leone Pascual A. Lateralized effect of rapid-rate transcranial magnetic stimulation of the prefrontal cortex on mood. Neurology. 1996 Feb;46(2):499-502. doi: 10.1212/wnl.46.2.499.
Reference Type
BACKGROUND
Paulus W. Transcranial direct current stimulation (tDCS). Suppl Clin Neurophysiol. 2003;56:249-54. doi: 10.1016/s1567-424x(09)70229-6.
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
Rossini PM, Barker AT, Berardelli A, Caramia MD, Caruso G, Cracco RQ, Dimitrijevic MR, Hallett M, Katayama Y, Lucking CH, et al. Non-invasive electrical and magnetic stimulation of the brain, spinal cord and roots: basic principles and procedures for routine clinical application. Report of an IFCN committee. Electroencephalogr Clin Neurophysiol. 1994 Aug;91(2):79-92. doi: 10.1016/0013-4694(94)90029-9. No abstract available.
Reference Type
BACKGROUND
Stagg CJ, O'Shea J, Kincses ZT, Woolrich M, Matthews PM, Johansen-Berg H. Modulation of movement-associated cortical activation by transcranial direct current stimulation. Eur J Neurosci. 2009 Oct;30(7):1412-23. doi: 10.1111/j.1460-9568.2009.06937.x. Epub 2009 Sep 29.
Reference Type
BACKGROUND
Torrance N, Smith BH, Bennett MI, Lee AJ. The epidemiology of chronic pain of predominantly neuropathic origin. Results from a general population survey. J Pain. 2006 Apr;7(4):281-9. doi: 10.1016/j.jpain.2005.11.008.
Reference Type
BACKGROUND
Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Chronic motor cortex stimulation in patients with thalamic pain. J Neurosurg. 1993 Mar;78(3):393-401. doi: 10.3171/jns.1993.78.3.0393.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
38RC14.130
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Efficacy of Home-delivered Transcranial Direct Electrical Stimulation or Chronic Pain
NCT07211256
RECRUITING
NA
Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,
NCT04936646
RECRUITING
NA
Effect of TMS on Neuropathic Pain for Patients With Sci
NCT07293780
RECRUITING
NA
Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis
NCT02059096
UNKNOWN
PHASE3
Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer
NCT07187219
RECRUITING
NA
Observational Study of the Analgesic Effect of Treatment With rTMS in Patients With Chronic Neuropathic Pain
NCT02506699
UNKNOWN
Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain
NCT02386969
COMPLETED
NA
Protocol Assessment of Motor Cortex rTMS for Treating Neuropathic Pain
NCT06964243
RECRUITING
NA
Optimize the Effects of Repetitive Transcranial Magnetic Stimulation on Neuropathic Pain
NCT05338554
COMPLETED
NA
Anodal Transcranial Direct Current Stimulation of the Visual Cortex Versus Sham Stimulation in the Episodic Migraine
NCT02122757
WITHDRAWN
NA
Comparison of rTMS and H Coil in Neuropathic Pain
NCT03370107
COMPLETED
NA
Efficacy of Non-Invasive Neuromodulation on Pain in Migraine
NCT07081685
NOT_YET_RECRUITING
NA
Neuromodulation in Patients With Neuropathic Pain and Depression.
NCT06129890
RECRUITING
NA
Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain
NCT05295498
RECRUITING
NA
Transcranial Direct Current Stimulation for Chronic Low Back Pain
NCT02768129
COMPLETED
NA
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
NCT05593237
RECRUITING
NA
Neuronavigated Repetitive Transcranial Magnetic Stimulation (nrTMS) of the Dorsolateral Prefrontal and Primary Motor Cortex for the Treatment of Chronic Pain
NCT04934150
COMPLETED
NA
Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Pain Perception in Parkinson's Disease
NCT01275573
COMPLETED
PHASE2
Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain
NCT01402960
COMPLETED
NA
Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy
NCT02747758
TERMINATED
NA
rTMS for the Treatment of Neuropathic Pain in Diabetic Patients
NCT05792072
ENROLLING_BY_INVITATION
NA
Transcranial Magnetic Stimulation (TMS) for Upper Limb Dysfunction in Spinal Cord Injury: a Feasibility Study
NCT02914418
COMPLETED
NA
Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia
NCT04120129
UNKNOWN
NA
Effects and Mechanism of Prolonged Continuous Theta Burst Stimulation on Neuropathic Pain
NCT05168319
COMPLETED
NA
Transcranial Magnetic Stimulation Therapy in Neuropathic Painful Spinal Cord Injury Patients
NCT05645003
RECRUITING
NA