Neuromodulation in Patients With Neuropathic Pain and Depression.
DOLODEP
2 other identifiers
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2023
CompletedFirst Posted
Study publicly available on registry
November 13, 2023
CompletedStudy Start
First participant enrolled
April 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
July 1, 2025
June 1, 2025
4.4 years
October 24, 2023
June 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Neuropathic dimension
Up to 26 weeks
Pain evolution
Up to 26 weeks
Progression of depression (Montgomery Asberg Depression Rating Scale - MADRS)
2 weeks after rTMS sessions
Progression of depression (Beck Depression Inventory - BDI)
2 weeks after rTMS sessions
Changes in mean pain intensity
2 weeks after rTMS sessions
- +4 more secondary outcomes
Study Arms (2)
M1 - DLPFC
OTHERInitial primary motor cortex stimulation (M1) followed by cortex prefrontal cortex (DLPFC) : rTMS of M1, washout, rTMS of DLPFC
DLPFC - M1
OTHERInitial cortex prefrontal cortex (DLPFC) stimulation followed by primary motor cortex stimulation (M1) : rTMS of DLPFC, washout, rTMS of M1
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Patient unable to understand informed consent
- Patient unwilling or unable to stop treatments prohibited during the study
- Patient deprived of liberty or under legal protection (guardianship, curatorship, safeguard of justice safeguard, family safeguard)
- Minor patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Saint-Etienne
Saint-Etienne, 42055, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2023
First Posted
November 13, 2023
Study Start
April 26, 2024
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
July 1, 2025
Record last verified: 2025-06