Pharmacoresistant Neuropathic Pain
Conditions
Keywords
pain, neuropathic, cortical stimulation, motor cortex, plasticity, rTMS, tDCS
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.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation
Five sessions of HF-rTMS or tDCS applied daily during 5 consecutive days
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Here the Time Frames : Baseline; 1 week; 2 week; 3 week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | actimetry measures |
| 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 | the patient is asked to evaluate each day the quality of his sleep using a numerical scale from 0 to 10. |
| 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 | Electrical stimulation of variable intensities applied on the hand |
| evaluation of motor cortex plasticity | 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 |
Countries
France
Outcome results
None listed