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

Civil Hospices of Lyon

Status: Completed

Conditions: Neuropathic Pain

Treatments: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02849834

2008-A01437-38 (Other Identifier)

2008-505

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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65 participants in 2 patient groups

healthy volunteers

Active Comparator group

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Patients with resistant pain

Experimental group

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)