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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849834
• Other study ID #: 2008-505
• Secondary ID: 2008-A01437-38
• Status: Completed
• Phase: N/A
• Start date: November 2009
• Est. completion date: November 21, 2016

Study information

• Verified date: July 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 21, 2016
• Est. primary completion date: November 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Neuralgia
• Neuropathic Pain

Intervention

Device:
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cortical plasticity induced by rTMS - - Somatosensory evoked potentials	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)	just before the isolated 20 Hz or theta-burst stimulation for healthy subjects
Primary	cortical plasticity induced by rTMS - - Somatosensory evoked potentials	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)	just after the isolated 20 Hz or theta-burst stimulation for healthy subjects
Primary	cortical plasticity induced by rTMS -- fMRI	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)	within 1 week before the first day of stimulation (20 Hz or theta-burst) for the patients
Primary	cortical plasticity induced by rTMS -- fMRI	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)	after the 5th day of stimulation (20 Hz or theta-burst) for the patients
Secondary	Nonparametric (Chi-2) contrast of dichotomized pain reports before/after rTMS and extent of fMRI activation change (also dichotomized) MRI T1 3D and T2*		within 1 week before the first day of stimulation Stats after 40 patients studied.
Secondary	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.
Secondary	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*,		within 1 week before the first day of stimulation Stats after 40 patients studied.
Secondary	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.