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Completed

NCT Number: NCT01800136

Analgesic Effect of Non Invasive Stimulation : Comparison of rTMS and tDCS Efficacy

The aim of this study is to compare analgesic efficacy of two non invasive techniques based on motor cortex stimulation in neuropathic pain patients. High frequency repetitive transcranial magnetic stimulation (HF-rTMS) of primary motor cortex has been demonstrated to induce an analgesic effect significantly different from placebo; this effect is clinically useful if rTMS sessions are applied daily during five consecutive days. Transcranial direct current stimulation (tDCS) is a new approach of non invasive cortical stimulation but its efficacy in neuropathic pain has been not yet established. The investigators propose to compare the analgesic effect of 5 tDCS sessions applied daily to a similar protocol using HF-rTMS. In parallel to the clinical therapeutic evaluation, functional-MRI will be performed before and after the five sessions of rTMS and tDCS, in order to reveal the potential plasticity induced within motor somatotopic map of the primary motor cortex.

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Key information

Conditions

Pharmacoresistant Neuropathic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique de Lyon et Unité " Intégration Centrale de la Douleur ", 1028 Inserm - UCBL

Lyon, 69000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients aged from 18 to 80 years, male or female, fully informed and having given their written consent
  • pharmacoresistant neuropathic pain during at least one year, without any change of the pharmacological treatment since at least one month

Exclusion criteria

  • drug addiction, headache, epilepsy history
  • ferromagnetic intracranial device
  • implanted stimulator
  • absence of contraceptive method for women of childbearing age

Treatment and study plan

Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation

Device

Five sessions of HF-rTMS or tDCS applied daily during 5 consecutive days

Primary outcomes

  1. Change from Baseline in Pain at the end of the stimulation week Change from Baseline in Pain at the end of the first post-stimulation week Change from Baseline in Pain at the end of the second post-stimulation week

    Time frame: Here the Time Frames : Baseline; 1 week; 2 week; 3 week

Secondary outcomes

  1. objective evaluation of sleep quality

    Time frame: Change from Baseline in percentage of sleep time at the end of the stimulation week; at the end of the first post-stimulation week; and at the end of the of the second post-stimulation week

    actimetry measures

  2. subjective evaluation of sleep quality using a numerical auto-evaluation scale

    Time frame: Change from Baseline in level of tiredness at the end of the stimulation week;at the end of the first post-stimulation week; and at the end of the second post-stimulation week

    the patient is asked to evaluate each day the quality of his sleep using a numerical scale from 0 to 10.

  3. nociceptive and non-nociceptive thresholds

    Time frame: Change from Baseline in nociceptive threshold after the first day of stimulation;after the fifth day of stimulation;Change from Baseline in non-nociceptive threshold after the first day of stimulation;and after the fifth day of stimulation

    Electrical stimulation of variable intensities applied on the hand

  4. evaluation of motor cortex plasticity

    Time frame: Change from Baseline in three-dimensional location of the activation peaks at the end of the stimulation week

    displacement of activation locus found after voluntary movements; comparison of the plastic and analgesic effects of rTMS or tDCS

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Non-invasive Cortical Stimulation for Pharmacoresistant Neuropathic Pain: rTMS Versus tDCS

Acronym: NI-MCS

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2013
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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