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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06129890
Other study ID # 23CH155
Secondary ID ANSM
Status Recruiting
Phase N/A
First received
Last updated
Start date April 26, 2024
Est. completion date March 2029

Study information

Verified date April 2024
Source Centre Hospitalier Universitaire de Saint Etienne
Contact Roland PEYRON, PhD
Phone (0)4 77 12 78 05
Email roland.peyron@univ-st-etienne.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 2029
Est. primary completion date September 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Central or peripheral neuropathic pain - Chronic pain (present for more than 6 months) with intensity greater than or equal to 4/10 on the numerical scale - Pain present on a daily or near-daily basis (at least 4 days a week) - Patient not completely relieved by recommended drug treatments for first- and second-line neuropathic pain - Stable analgesic treatment (no new treatment or dosage adjustment) for at least one month, and will not need to be modified for the duration of the study. - Patient with a depressive episode characterized according to DSM V criteria - Indication for motor cortex rTMS by a neurologist - Patient can be followed for the entire duration of the study - Patient having received informed consent to participate in the study, and having co-signed a consent form with the investigator - Member or beneficiary of a social security scheme Exclusion Criteria: - Industrial accident or litigation - Contraindication to rTMS or MRI (seismotherapy treatment since the previous month; epilepsy and/or history of epilepsy; history of head trauma; neurosurgical lesion; intracranial hypertension; intracerebral metal clip; piercing; pacemaker; insulin pump; metal prosthesis; pregnant or breast-feeding woman; claustrophobia) - Drug or psychoactive substance abuse - Neuropathic pain in the context of a progressive pathology (HIV, cancer, systemic disease disease) - Presence of other pain more severe than that justifying inclusion - Patient unable to understand informed consent - Patient unwilling or unable to stop treatments prohibited during the study - Patient participating in another research protocol involving a drug within the 30 days prior to inclusion - Patient deprived of liberty or under legal protection (guardianship, curatorship, safeguard of justice safeguard, family safeguard) - Minor patient

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Repetitive transcranial magnetic stimulation (rTMS) - M1/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 M1 then rTMS of DLPFC.
Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1
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.

Locations

Country Name City State
France CHU de Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison 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. 2 weeks after the last rTMS session for each arm
Secondary 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)
Up to 26 weeks
Secondary 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"). Up to 26 weeks
Secondary 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). 2 weeks after rTMS sessions
Secondary 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. 2 weeks after rTMS sessions
Secondary 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"). 2 weeks after rTMS sessions
Secondary 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. 2 weeks after rTMS sessions
Secondary 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 2 weeks after rTMS sessions
Secondary 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). 2 weeks after rTMS sessions
Secondary Adverse events Potential adverse events reporting during the study Up to 26 weeks
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