Cortical Plasticity After Motor Cortex Stimulation in Healthy Subject and Chronic Pain Patients
Primary Purpose
Neuropathic Pain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic Pain, Stimulation of the Motor Cortex (SCM), Pharmacoresistant, rTMS
Eligibility Criteria
Inclusion Criteria:
- healthy subjects aged from 18 to 70 years, male or female, with social protection, fully informed and having given their written consent.
patients :
- aged from 18 to 80 years, male or female, with social protection , fully informed and having given their written consent.
- unilateral pharmacoresistant neuropathic pain during at least one year,
- without any change of the pharmacological treatment since at least one month
Exclusion Criteria:
- for healthy subjects only:
- history of chronic pain
- analgesic medication within 24h before stimulation
For patients only: new analgesic treatment within 1 month before consent
for both:
- drug addiction, headache, epilepsy history
- ferromagnetic intracranial device
- implanted stimulator
- absence of contraceptive method for women of childbearing age
Sites / Locations
- Service d'Exploration, Centre Hospitalier Lyon Est, Hospices civils de Lyon, Lyon, F-69495, France et NeuroPain lab - CRNL (Inserm U1028 - UCBL)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
healthy volunteers
Patients with resistant pain
Arm Description
Outcomes
Primary Outcome Measures
cortical plasticity induced by rTMS - - Somatosensory evoked potentials
Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients.
In healthy subjects, mapping of cortical responses amplitude and source reconstruction techniques (dipole modelisation, BESA) before / after a single rTMS session
In chronic pain patients, contrast analysis between extent and location of motor activations (to hand, foot and mouth contraction) before / after one week of daily rTMS, analysed with Statistical Parametric Mapping (SPM12)
cortical plasticity induced by rTMS - - Somatosensory evoked potentials
Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients.
In healthy subjects, mapping of cortical responses amplitude and source reconstruction techniques (dipole modelisation, BESA) before / after a single rTMS session
In chronic pain patients, contrast analysis between extent and location of motor activations (to hand, foot and mouth contraction) before / after one week of daily rTMS, analysed with Statistical Parametric Mapping (SPM12)
cortical plasticity induced by rTMS -- fMRI
Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients.
In healthy subjects, mapping of cortical responses amplitude and source reconstruction techniques (dipole modelisation, BESA) before / after a single rTMS session
In chronic pain patients, contrast analysis between extent and location of motor activations (to hand, foot and mouth contraction) before / after one week of daily rTMS, analysed with Statistical Parametric Mapping (SPM12)
cortical plasticity induced by rTMS -- fMRI
Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients.
In healthy subjects, mapping of cortical responses amplitude and source reconstruction techniques (dipole modelisation, BESA) before / after a single rTMS session
In chronic pain patients, contrast analysis between extent and location of motor activations (to hand, foot and mouth contraction) before / after one week of daily rTMS, analysed with Statistical Parametric Mapping (SPM12)
Secondary Outcome Measures
Nonparametric (Chi-2) contrast of dichotomized pain reports before/after rTMS and extent of fMRI activation change (also dichotomized) MRI T1 3D and T2*
Nonparametric (Chi-2) contrast of dichotomized pain reports before/after rTMS and extent of fMRI activation change (also dichotomized) MRI T1 3D and T2*
Linear and nonlinear correlation between the magnitude of induced cortical plasticity and the magnitude of pain relief induced by rTMS. MRI T1 3D and T2*,
Linear and nonlinear correlation between the magnitude of induced cortical plasticity and the magnitude of pain relief induced by rTMS. MRI T1 3D and T2*,
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02849834
Brief Title
Cortical Plasticity After Motor Cortex Stimulation in Healthy Subject and Chronic Pain Patients
Official Title
Study of Sensory-motor Cortex Plasticity After Motor Cortex Stimulation in Healthy Subject and Chronic Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 21, 2016 (Actual)
Study Completion Date
November 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of this study is to evaluate the induction of sensory-motor cortex plasticity after motor cortex stimulation in healthy subjects, using laser-evoked nociceptive cortical potentials, and in chronic neuropathic pain patients using functional MRI. As a secondary goal, the project will analyse possible correlations between the magnitude of cortical plasticity and that of the pain-relieving effect.
In healthy subjects, cortical plasticity is evaluated by the comparison of somatosensory cortical maps before and after two isolated sessions of 20 Hz and theta-burst rTMS, in a cross-over randomized study.
Two sessions of 5 consecutive days of rTMS are proposed to the patients with a minimum of 4 weeks between the two sessions, defined by 20 Hz and theta-burst stimulation in a cross-over randomized order. Cortical plasticity of the motor cortex is evaluated via functional MRI (motor activation) performed before the first rTMS session and the last day of each session of rTMS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Neuropathic Pain, Stimulation of the Motor Cortex (SCM), Pharmacoresistant, rTMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
healthy volunteers
Arm Type
Active Comparator
Arm Title
Patients with resistant pain
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
20Hz and Theta Burst stimulation, both at 80% of motor threshold in contralateral intrinsic hand muscles. Five consecutive days of each mode of stimulation, separated by a minimum of 4 weeks. Daily self-monitoring of pain, sleep quality and fatigue by mans of a 10-item questionnaire
Primary Outcome Measure Information:
Title
cortical plasticity induced by rTMS - - Somatosensory evoked potentials
Description
Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients.
In healthy subjects, mapping of cortical responses amplitude and source reconstruction techniques (dipole modelisation, BESA) before / after a single rTMS session
In chronic pain patients, contrast analysis between extent and location of motor activations (to hand, foot and mouth contraction) before / after one week of daily rTMS, analysed with Statistical Parametric Mapping (SPM12)
Time Frame
just before the isolated 20 Hz or theta-burst stimulation for healthy subjects
Title
cortical plasticity induced by rTMS - - Somatosensory evoked potentials
Description
Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients.
In healthy subjects, mapping of cortical responses amplitude and source reconstruction techniques (dipole modelisation, BESA) before / after a single rTMS session
In chronic pain patients, contrast analysis between extent and location of motor activations (to hand, foot and mouth contraction) before / after one week of daily rTMS, analysed with Statistical Parametric Mapping (SPM12)
Time Frame
just after the isolated 20 Hz or theta-burst stimulation for healthy subjects
Title
cortical plasticity induced by rTMS -- fMRI
Description
Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients.
In healthy subjects, mapping of cortical responses amplitude and source reconstruction techniques (dipole modelisation, BESA) before / after a single rTMS session
In chronic pain patients, contrast analysis between extent and location of motor activations (to hand, foot and mouth contraction) before / after one week of daily rTMS, analysed with Statistical Parametric Mapping (SPM12)
Time Frame
within 1 week before the first day of stimulation (20 Hz or theta-burst) for the patients
Title
cortical plasticity induced by rTMS -- fMRI
Description
Assessment of plastic changes induced in sensori-motor cortex by the application of repetitive magnetic stimulation in healthy subjects and chronic pain patients.
In healthy subjects, mapping of cortical responses amplitude and source reconstruction techniques (dipole modelisation, BESA) before / after a single rTMS session
In chronic pain patients, contrast analysis between extent and location of motor activations (to hand, foot and mouth contraction) before / after one week of daily rTMS, analysed with Statistical Parametric Mapping (SPM12)
Time Frame
after the 5th day of stimulation (20 Hz or theta-burst) for the patients
Secondary Outcome Measure Information:
Title
Nonparametric (Chi-2) contrast of dichotomized pain reports before/after rTMS and extent of fMRI activation change (also dichotomized) MRI T1 3D and T2*
Time Frame
within 1 week before the first day of stimulation Stats after 40 patients studied.
Title
Nonparametric (Chi-2) contrast of dichotomized pain reports before/after rTMS and extent of fMRI activation change (also dichotomized) MRI T1 3D and T2*
Time Frame
after the 5th day of stimulation. Stats after 40 patients studied.
Title
Linear and nonlinear correlation between the magnitude of induced cortical plasticity and the magnitude of pain relief induced by rTMS. MRI T1 3D and T2*,
Time Frame
within 1 week before the first day of stimulation Stats after 40 patients studied.
Title
Linear and nonlinear correlation between the magnitude of induced cortical plasticity and the magnitude of pain relief induced by rTMS. MRI T1 3D and T2*,
Time Frame
after the 5th day of stimulation. Stats after 40 patients studied.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy subjects aged from 18 to 70 years, male or female, with social protection, fully informed and having given their written consent.
patients :
aged from 18 to 80 years, male or female, with social protection , fully informed and having given their written consent.
unilateral pharmacoresistant neuropathic pain during at least one year,
without any change of the pharmacological treatment since at least one month
Exclusion Criteria:
for healthy subjects only:
history of chronic pain
analgesic medication within 24h before stimulation
For patients only: new analgesic treatment within 1 month before consent
for both:
drug addiction, headache, epilepsy history
ferromagnetic intracranial device
implanted stimulator
absence of contraceptive method for women of childbearing age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie ANDRE-OBADIA, MD
Organizational Affiliation
Service d'Exploration, Centre Hospitalier Lyon Est, Hospices civils de Lyon, Lyon, F-69495, France et NeuroPain lab - CRNL (Inserm U1028 - UCBL)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Exploration, Centre Hospitalier Lyon Est, Hospices civils de Lyon, Lyon, F-69495, France et NeuroPain lab - CRNL (Inserm U1028 - UCBL)
City
Bron
ZIP/Postal Code
69500
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Cortical Plasticity After Motor Cortex Stimulation in Healthy Subject and Chronic Pain Patients
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