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Completed

NCT Number: NCT02849834

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

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bron, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

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 outcomes

  1. cortical plasticity induced by rTMS - - Somatosensory evoked potentials

    Time frame: just before 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)

  2. cortical plasticity induced by rTMS - - Somatosensory evoked potentials

    Time frame: just 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)

  3. cortical plasticity induced by rTMS -- fMRI

    Time frame: within 1 week before the first 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)

  4. cortical plasticity induced by rTMS -- fMRI

    Time frame: after 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Study of Sensory-motor Cortex Plasticity After Motor Cortex Stimulation in Healthy Subject and Chronic Pain Patients

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2016
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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