High-frequency repetitive transcranial magnetic stimulation of the primary motor cortex has shown its effect on refractory neuropathic pain, and rTMS of the dorsolateral prefrontal cortex is commonly used for treatment-resistant depression. The treatment for patients suffering from neuropathic pain and depression, concomitantly, still needs to be studied, as there are some specificities in both symptoms and brain functional MRI.
This project is a cross-over study for these patients, including 4 sessions of either M1 or DLPFC rTMS, a wash-out period, followed by 4 sessions of the other stimulation site, to assess the efficiency of a DLPFC rTMS for neuropathic pain with a comorbid depression. Besides pain intensity and quality, patient's mood, quality of life, and catastrophizing will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Repetitive transcranial magnetic stimulation (rTMS) is a treatment technique involving the induction of an electrical current on the surface of the cortex by applying a magnetic field to the scalp. This field is generated using a stimulation loop controlled by a robotic arm linked to a neuronavigation system. rTMS of M1 then rTMS of DLPFC.
Repetitive transcranial magnetic stimulation (rTMS) is a treatment technique involving the induction of an electrical current on the surface of the cortex by applying a magnetic field to the scalp. This field is generated using a stimulation loop controlled by a robotic arm linked to a neuronavigation system. rTMS of DLPFC then rTMS of M1.
CHU de Saint-Etienne
Saint-Etienne, France
RECRUITINGComparison of pain relief rates between the two stimulation targets (M1 and DLPFC)
Patients are asked how much pain relief they have experienced since the last session.
Time frame: 2 weeks after the last rTMS session for each arm
Neuropathic dimension
Neuropathic dimension: overall score of the Neuropathic Pain Symptoms Inventory (NPSI) questionnaire and its dominant sub-score. The dominant being defined as the score of the dimension (e.g. allodynia, burning, dysesthesia) most painful at the inclusion visit (S0).This questionnaire is used to assess the presence and evolution of neuropathic pain symptoms, as well as the effectiveness of specific neuropathic pain treatments. Based on questioning, it comprises 12 questions (10 descriptive of symptoms and and 2 to assess pain frequency and duration). Score is from 0 ((no pain) to 120 (maximun pain)
Time frame: Up to 26 weeks
Pain evolution
Pain evolution via multiple Visual Analogue Scale (components: intensity, unpleasantness, impact on on attention). (Minimum Value : 0 means "no pain" - Maximum value : 10 means "the most intense pain imaginable").
Time frame: Up to 26 weeks
Progression of depression (Montgomery Asberg Depression Rating Scale - MADRS)
Progression of depression (thymia), assessed by subjective percentage improvement in mood by the MADRS. Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items to be completed during a clinical interview. Each item has a severity scale from 0 to 6, with higher scores reflecting more severe symptoms. Scores can be added together to give an overall score (from 0 to 60).
Time frame: 2 weeks after rTMS sessions
Progression of depression (Beck Depression Inventory - BDI)
Progression of depression (thymia), assessed by subjective percentage improvement in mood by the Beck Depression Inventory (BDI). It provides a quantitative estimate of depression intensity. Each item consists of 4 sentences corresponding to 4 degrees of increasing intensity on a scale from 0 to 3. The overall score for the depressive syndrome (from 0 to 39) is obtained by adding up the scores for the 13 items.
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Time frame: 2 weeks after rTMS sessions
Changes in mean pain intensity
Comparison of changes in mean pain intensity between the two treatment arms by using Visual Analogue Scale (components: intensity, unpleasantness, impact on on attention). (Minimum Value : 0 means "no pain" - Maximum value : 10 means "the most intense pain imaginable").
Time frame: 2 weeks after rTMS sessions
Evolution of catastrophism
Evolution of catastrophism via the Pain Catastrophizing Scale. People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness.
Time frame: 2 weeks after rTMS sessions
Evolution of affective and sensory components of pain
Evolution of affective and sensory components of pain via the Pain Questionnaire Saint-Antoine (QDSA). This questionnaire contains 58 words divided into 16 categories offering dimensions that to describe the painful experience
Time frame: 2 weeks after rTMS sessions
Change in perceived quality of life
Change in perceived quality of life using the EuroQol-5D (EQ5-D). The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Time frame: 2 weeks after rTMS sessions
Adverse events
Potential adverse events reporting during the study
Time frame: Up to 26 weeks