Clinical trial NCT01800136: Analgesic Effect of Non Invasive Stimulation : Comparison of rTMS and tDCS Efficacy
Official title: Non-invasive Cortical Stimulation for Pharmacoresistant Neuropathic Pain: rTMS Versus tDCS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacoresistant Neuropathic Pain
Keywords: pain
neuropathic
cortical stimulation
motor cortex
plasticity
rTMS
tDCS
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Here the Time Frames : Baseline; 1 week; 2 week; 3 week
Secondary outcomes:
measure: objective evaluation of sleep quality
timeFrame: 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
measure: subjective evaluation of sleep quality using a numerical auto-evaluation scale
timeFrame: 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
measure: nociceptive and non-nociceptive thresholds
timeFrame: 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
measure: evaluation of motor cortex plasticity
timeFrame: Change from Baseline in three-dimensional location of the activation peaks at the end of the stimulation week
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique de Lyon et Unité " Intégration Centrale de la Douleur ", 1028 Inserm - UCBL
Study officials:
References: