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Cortical Plasticity After Motor Cortex Stimulation in Healthy Subject and Chronic Pain Patients

Not Applicable
Completed
Conditions
Neuropathic Pain
Interventions
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Registration Number
NCT02849834
Lead Sponsor
Hospices Civils de Lyon
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
65
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Patients with resistant painRepetitive Transcranial Magnetic Stimulation (rTMS)-
healthy volunteersRepetitive Transcranial Magnetic Stimulation (rTMS)-
Primary Outcome Measures
NameTimeMethod
cortical plasticity induced by rTMS - - Somatosensory evoked potentialsjust after the isolated 20 Hz or theta-burst stimulation for healthy subjects

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 -- fMRIafter the 5th day of stimulation (20 Hz or theta-burst) for the patients

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
NameTimeMethod
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*,after the 5th day of stimulation. Stats after 40 patients studied.
Nonparametric (Chi-2) contrast of dichotomized pain reports before/after rTMS and extent of fMRI activation change (also dichotomized) MRI T1 3D and T2*after the 5th day of stimulation. Stats after 40 patients studied.

Trial Locations

Locations (1)

Service d'Exploration, Centre Hospitalier Lyon Est, Hospices civils de Lyon, Lyon, F-69495, France et NeuroPain lab - CRNL (Inserm U1028 - UCBL)

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Bron, France

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