NCT02849834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2016

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

7.1 years

First QC Date

July 26, 2016

Last Update Submit

November 18, 2025

Conditions

Neuropathic Pain

Keywords

Neuropathic PainStimulation of the Motor Cortex (SCM)PharmacoresistantrTMS

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (2)

healthy volunteers

ACTIVE COMPARATOR
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Patients with resistant pain

EXPERIMENTAL
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)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 painhealthy volunteers

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bron, 69500, France

Location

Related Publications (1)

  • Andre-Obadia N, Hodaj H, Hodaj E, Simon E, Delon-Martin C, Garcia-Larrea L. Better Fields or Currents? A Head-to-Head Comparison of Transcranial Magnetic (rTMS) Versus Direct Current Stimulation (tDCS) for Neuropathic Pain. Neurotherapeutics. 2023 Jan;20(1):207-219. doi: 10.1007/s13311-022-01303-x. Epub 2022 Oct 20.

    PMID: 36266501RESULT

MeSH Terms

Conditions

Neuralgia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

July 29, 2016

Study Start

November 1, 2009

Primary Completion

November 21, 2016

Study Completion

November 21, 2016

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)