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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2016-11-21

Brief Summary

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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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Detailed Description

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Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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healthy volunteers

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type 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

Patients with resistant pain

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type 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

Interventions

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Repetitive Transcranial Magnetic Stimulation (rTMS)

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes