Clinical trial NCT02849834: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: Neuropathic Pain
Stimulation of the Motor Cortex (SCM)
Pharmacoresistant
rTMS
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: cortical plasticity induced by rTMS - - Somatosensory evoked potentials
timeFrame: just before the isolated 20 Hz or theta-burst stimulation for healthy subjects
measure: cortical plasticity induced by rTMS - - Somatosensory evoked potentials
timeFrame: just after the isolated 20 Hz or theta-burst stimulation for healthy subjects
measure: cortical plasticity induced by rTMS -- fMRI
timeFrame: within 1 week before the first day of stimulation (20 Hz or theta-burst) for the patients
measure: cortical plasticity induced by rTMS -- fMRI
timeFrame: after the 5th day of stimulation (20 Hz or theta-burst) for the patients
Secondary outcomes:
measure: Nonparametric (Chi-2) contrast of dichotomized pain reports before/after rTMS and extent of fMRI activation change (also dichotomized) MRI T1 3D and T2*
timeFrame: within 1 week before the first day of stimulation Stats after 40 patients studied.
measure: Nonparametric (Chi-2) contrast of dichotomized pain reports before/after rTMS and extent of fMRI activation change (also dichotomized) MRI T1 3D and T2*
timeFrame: after the 5th day of stimulation. Stats after 40 patients studied.
measure: 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*,
timeFrame: within 1 week before the first day of stimulation Stats after 40 patients studied.
measure: 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*,
timeFrame: after the 5th day of stimulation. Stats after 40 patients studied.
Other outcomes:
Locations:
city: Bron
country: France
facility: Service d'Exploration, Centre Hospitalier Lyon Est, Hospices civils de Lyon, Lyon, F-69495, France et NeuroPain lab - CRNL (Inserm U1028 - UCBL)
Study officials:
affiliation: Service d'Exploration, Centre Hospitalier Lyon Est, Hospices civils de Lyon, Lyon, F-69495, France et NeuroPain lab - CRNL (Inserm U1028 - UCBL)
name: Nathalie ANDRE-OBADIA, MD
role: PRINCIPAL_INVESTIGATOR
References: