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Analgesic Stimulation Non-invasive of the Motor Cortex (DOLORIS)

Primary Purpose

Neuropathic Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tDCS session
rTMS session
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neuropathic Chronic Pain focused on measuring Pain, Analgesic, Stimulation, Motor Cortex

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • UniversityHospitalGrenobleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MRI by rTMS

MRI by tDCS

Arm Description

Patients which received an MRI study of cortical plasticity by rTMS.

Patients which received an MRI study of cortical plasticity by tDCS.

Outcomes

Primary Outcome Measures

High-frequency
rTMS session : repetitive transcranial magnetic stimulation. MRI
High-frequency
tDCS session : direct current transcranial magnetic stimulation. MRI

Secondary Outcome Measures

Full Information

First Posted
July 25, 2016
Last Updated
July 29, 2016
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02854332
Brief Title
Analgesic Stimulation Non-invasive of the Motor Cortex
Acronym
DOLORIS
Official Title
Evaluation of Repetitive Magnetic Stimulation Versus Direct Current Stimulation, in Chronic Neuropathic and Drug-resistant Pain Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Chronic Pain
Keywords
Pain, Analgesic, Stimulation, Motor Cortex

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI by rTMS
Arm Type
Active Comparator
Arm Description
Patients which received an MRI study of cortical plasticity by rTMS.
Arm Title
MRI by tDCS
Arm Type
Active Comparator
Arm Description
Patients which received an MRI study of cortical plasticity by tDCS.
Intervention Type
Device
Intervention Name(s)
tDCS session
Other Intervention Name(s)
MRI
Intervention Description
Direct current transcranial magnetic stimulation
Intervention Type
Device
Intervention Name(s)
rTMS session
Other Intervention Name(s)
MRI
Intervention Description
Repetitive transcranial magnetic stimulation.
Primary Outcome Measure Information:
Title
High-frequency
Description
rTMS session : repetitive transcranial magnetic stimulation. MRI
Time Frame
Half an hour
Title
High-frequency
Description
tDCS session : direct current transcranial magnetic stimulation. MRI
Time Frame
Half an hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hasan Hodaj, Doctor
Phone
0476765213
Email
HHodaj@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Pierre Alibeu, Doctor
Phone
04 76 76 52 13
Email
JPAlibeu@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan Hodaj, Doctor
Organizational Affiliation
Grenoble Hospital University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UniversityHospitalGrenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hasan Hodaj, Doctor
Phone
0476765213
Email
HHodaj@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Alibeu, Doctor
Phone
04 76 76 52 13
Email
JPAlibeu@chu-grenoble.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
10432797
Citation
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.
Results Reference
background
PubMed Identifier
18779511
Citation
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.
Results Reference
background
PubMed Identifier
16753335
Citation
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.
Results Reference
background
PubMed Identifier
17038030
Citation
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.
Results Reference
background
PubMed Identifier
2872449
Citation
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.
Results Reference
background
PubMed Identifier
15030944
Citation
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.
Results Reference
background
PubMed Identifier
17888574
Citation
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.
Results Reference
background
PubMed Identifier
17718686
Citation
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.
Results Reference
background
PubMed Identifier
16564618
Citation
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.
Results Reference
background
PubMed Identifier
17239806
Citation
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.
Results Reference
background
PubMed Identifier
17133529
Citation
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.
Results Reference
background
PubMed Identifier
17611487
Citation
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.
Results Reference
background
PubMed Identifier
17644413
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
15897507
Citation
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.
Results Reference
background
PubMed Identifier
15130555
Citation
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.
Results Reference
background
PubMed Identifier
17434804
Citation
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.
Results Reference
background
PubMed Identifier
9510224
Citation
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.
Results Reference
background
PubMed Identifier
10853116
Citation
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.
Results Reference
background
PubMed Identifier
19853048
Citation
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.
Results Reference
background
PubMed Identifier
7540735
Citation
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.
Results Reference
background
PubMed Identifier
10488675
Citation
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.
Results Reference
background
PubMed Identifier
12949224
Citation
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.
Results Reference
background
PubMed Identifier
10990547
Citation
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.
Results Reference
background
PubMed Identifier
16214292
Citation
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.
Results Reference
background
PubMed Identifier
21494222
Citation
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.
Results Reference
background
PubMed Identifier
8614521
Citation
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.
Results Reference
background
PubMed Identifier
14677402
Citation
Paulus W. Transcranial direct current stimulation (tDCS). Suppl Clin Neurophysiol. 2003;56:249-54. doi: 10.1016/s1567-424x(09)70229-6.
Results Reference
background
PubMed Identifier
19833552
Citation
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.
Results Reference
background
PubMed Identifier
7519144
Citation
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.
Results Reference
background
PubMed Identifier
19788568
Citation
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.
Results Reference
background
PubMed Identifier
16618472
Citation
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.
Results Reference
background
PubMed Identifier
8433140
Citation
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.
Results Reference
background
PubMed Identifier
22124038
Citation
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.
Results Reference
background

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Analgesic Stimulation Non-invasive of the Motor Cortex

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