Non-invasive Cortical Stimulation for Pharmacoresistant Neuropathic Pain: rTMS Versus tDCS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pharmacoresistant Neuropathic Pain
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
- subjective evaluation of sleep quality using a numerical auto-evaluation scale(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)
- nociceptive and non-nociceptive thresholds(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)
- evaluation of motor cortex plasticity(Change from Baseline in three-dimensional location of the activation peaks at the end of the stimulation week)
- objective evaluation of sleep quality(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)