PEYRON Roland
Saint-Etienne, 42055, France
Location status: Recruiting
NCT Number: NCT07187219
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Saint-Etienne, 42055, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
rTMS session active on the primary motor cortex
rTMS session inactive on the primary motor cortex
Time frame: Week 7 after the start of RTMs stimulation
PAIN from 0% : no pain relief at all to 100%: completely relief.
Time frame: day 7 post RTMs stimulation
0 no pain to 10 extremely pain
Time frame: day 7 post RTMs stimulation
[0= zero neuropatthic pain to 100= maximum neuropathic pain]
Time frame: day 7 post RTMs stimulation
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
scale ranging from 0% = no relief to 100% = fully relieved
Time frame: day 7 post RTMs stimulation
Visual Analogic Scale VAS (0 = not unpleasant) to 10 = extremely unpleasant)
Time frame: day 7 post RTMs stimulation
0 = does not attract at all to 10 = completely attracts
Time frame: Week 7 after the start of RTMs stimlulation
Time frame: Week 7 after the start of RTMs stimlulation
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
from 0 to 14: no anxiety disorders; from 15 to 42: existence of anxiety disorders.
Time frame: week 7 after the start of RTMs stimulation
Tolerance will be defined as the absence of adverse effects throughout the duration of the protocol, as reported in systematic questionnaires."
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Saint Etienne
Other
Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer: Cross-over and Placebo-control Study
Acronym: NeuroCanPain
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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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