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

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ClinicalTrials.gov Identifier: NCT02849834
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Neuropathic Pain Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Sensory-motor Cortex Plasticity After Motor Cortex Stimulation in Healthy Subject and Chronic Pain Patients
Study Start Date : November 2009
Actual Primary Completion Date : November 21, 2016
Actual Study Completion Date : November 21, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: healthy volunteers 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

Experimental: Patients with resistant pain 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




Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849834


Locations
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France
Service d'Exploration, Centre Hospitalier Lyon Est, Hospices civils de Lyon, Lyon, F-69495, France et NeuroPain lab - CRNL (Inserm U1028 - UCBL)
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Nathalie ANDRE-OBADIA, MD Service d'Exploration, Centre Hospitalier Lyon Est, Hospices civils de Lyon, Lyon, F-69495, France et NeuroPain lab - CRNL (Inserm U1028 - UCBL)

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02849834     History of Changes
Other Study ID Numbers: 2008-505
2008-A01437-38 ( Other Identifier: ID-RCB )
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
Neuropathic Pain
Stimulation of the Motor Cortex (SCM)
Pharmacoresistant
rTMS
Additional relevant MeSH terms:
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Neuralgia
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases