High-frequency repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex (M1) has shown its efficacy to alleviate pain in patients suffering from refractory neuropathic pain. rTMS is now considered as 3rd-line therapy (by the French Society for the Study and Treatment of Pain) for patient's refractory to drug therapy. However, its efficacy in chronic neuropathic pain related to cancer has not yet been specifically studied, and it therefore remains relatively inaccessible for these patients. This project is a cross-over, double-blinded, and placebo-control study, including 5 sessions of either M1 or "sham" rTMS, a wash-out period (8 weeks), followed by 5 sessions of the other stimulation option (I.e., two arms: M1-sham or sham-M1; order randomized between patients). Treatment efficacy will be assessed in comparison to the placebo condition. Primary outcome is the percentage of pain relief between active and sham rTMS. Other variables to describe quality of life, sensory, neuropathic, and mood states as well as resting-state fMRI will be collected before and after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
rTMS session active on the primary motor cortex
rTMS session inactive on the primary motor cortex
PEYRON Roland
Saint-Etienne, France
RECRUITINGPAIN RELIEF
PAIN from 0% : no pain relief at all to 100%: completely relief.
Time frame: Week 7 after the start of RTMs stimulation
Pain Intensity with Visual analog scale (VAS)
0 no pain to 10 extremely pain
Time frame: day 7 post RTMs stimulation
score of Neuropathic Pain Symptom Inventory - NPSI
\[0= zero neuropatthic pain to 100= maximum neuropathic pain\]
Time frame: day 7 post RTMs stimulation
Brief Pain Inventory - BPI
1 - 4 = Mild Pain. 5 =Worst Pain Score 6 = Moderate Pain. 7=Worst Pain Score 10 = Severe Pain.
Time frame: day 7 post RTMs stimulation
Pain relief
scale ranging from 0% = no relief to 100% = fully relieved
Time frame: day 7 post RTMs stimulation
Visual Analogic Scale VAS on emotional dimension of pain
Visual Analogic Scale VAS (0 = not unpleasant) to 10 = extremely unpleasant)
Time frame: day 7 post RTMs stimulation
Visual Analogic Scale (VAS) on attentional dimension of pain
0 = does not attract at all to 10 = completely attracts
Time frame: day 7 post RTMs stimulation
consumption of rescue analgesics
Time frame: Week 7 after the start of RTMs stimlulation
Effect of rTMS on quality of life
Quality of life score (EQ-5D) from 0 to 100. 100 corresponds to the best health.
Time frame: Week 7 after the start of RTMs stimlulation
HADS: Hospital Anxiety and Depression Scale
from 0 to 14: no anxiety disorders; from 15 to 42: existence of anxiety disorders.
Time frame: Week 7 after the start of RTMs stimlulation
Tolerance
Tolerance will be defined as the absence of adverse effects throughout the duration of the protocol, as reported in systematic questionnaires."
Time frame: week 7 after the start of RTMs stimulation
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