Neuropathic Chronic PainDOLORISNCT02854332
Analgesic Stimulation Non-invasive of the Motor Cortex
A study testing tDCS session and rTMS session in people with Neuropathic Chronic Pain, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Chronic Pain
- What is being tested?
- tDCS session and rTMS session
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UniversityHospitalGrenoble
La Tronche, 38700
Hasan Hodaj, Doctor, 0476765213, HHodaj@chu-grenoble.fr
Jean-Pierre Alibeu, Doctor, 04 76 76 52 13, JPAlibeu@chu-grenoble.fr
About this study
Official title: Evaluation of Repetitive Magnetic Stimulation Versus Direct Current Stimulation, in Chronic Neuropathic and Drug-resistant Pain Treatment
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.
Read more
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.
- Conditions
- Neuropathic Chronic Pain
- Being tested
- tDCS session, rTMS session
- Keywords
- Pain, Analgesic, Stimulation, Motor Cortex
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS sessionDevice
Also called MRI
Direct current transcranial magnetic stimulation
rTMS sessionDevice
Also called MRI
Repetitive transcranial magnetic stimulation.
| Study group | Role | What they receive |
|---|---|---|
| MRI by rTMS | Active comparator | Patients which received an MRI study of cortical plasticity by rTMS. Receives: Device: rTMS session |
| MRI by tDCS | Active comparator | Patients which received an MRI study of cortical plasticity by tDCS. Receives: Device: tDCS session |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-frequency
rTMS session : repetitive transcranial magnetic stimulation.
MRI
Measured: Half an hour
High-frequency
tDCS session : direct current transcranial magnetic stimulation.
MRI
Measured: Half an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Neuropathic Chronic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hasan Hodaj, Doctor, Principal investigator, Grenoble Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854332
- Sponsor's protocol ID
- 38RC14.130
- Acronym
- DOLORIS
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10432797Andre-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.
PubMed 18779511Andre-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.
PubMed 16753335Attal 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.
PubMed 17038030Barker 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.
PubMed 2872449Bouhassira 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.
PubMed 15030944Bouhassira 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.
PubMed 17888574Cruccu 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.
PubMed 17718686Fregni 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.
PubMed 16564618Fregni 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.
PubMed 17239806Fregni 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.
PubMed 17133529Fregni 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.
PubMed 17611487Garcia-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.
PubMed 17644413H. 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
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Repetitive Magnetic Stimulation Versus Direct Current Stimulation, in Chronic Neuropathic and Drug-resistant Pain Treatment
- ClinicalTrials.gov ID
- NCT02854332
- Acronym / sponsor ID
- DOLORIS / 38RC14.130
- Conditions
- Neuropathic Chronic Pain
- Keywords
- Pain, Analgesic, Stimulation, Motor Cortex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI by rTMS | Active comparator | Device: rTMS sessionPatients which received an MRI study of cortical plasticity by rTMS. |
| MRI by tDCS | Active comparator | Device: tDCS sessionPatients which received an MRI study of cortical plasticity by tDCS. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS sessionAlso: MRIDirect current transcranial magnetic stimulation | Device | MRI by tDCS |
| rTMS sessionAlso: MRIRepetitive transcranial magnetic stimulation. | Device | MRI by rTMS |
Primary outcome
High-frequency
Time frame: Half an hour
rTMS session : repetitive transcranial magnetic stimulation. MRI
High-frequency
Time frame: Half an hour
tDCS session : direct current transcranial magnetic stimulation. MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Background: PubMed 10432797Andre-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.
- Background: PubMed 18779511Andre-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.
- Background: PubMed 16753335Andre-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.
- Background: PubMed 17038030Attal 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.
- Background: PubMed 2872449Barker 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.
- Background: PubMed 15030944Bouhassira 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.
- Background: PubMed 17888574Bouhassira 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.
- Background: PubMed 17718686Cruccu 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.
- Background: PubMed 16564618Fregni 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.
- Background: PubMed 17239806Fregni 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.
- Background: PubMed 17133529Fregni 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.
- Background: PubMed 17611487Fregni 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.
Related trials for Neuropathic Chronic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasan Hodaj, Doctor principal investigator
Grenoble Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS session and rTMS session in people with Neuropathic Chronic Pain, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hasan Hodaj, Doctor (0476765213, HHodaj@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-frequency (time frame: Half an hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02854332, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.