Neuropathic PainDOLODEPNCT06129890
Neuromodulation in Patients With Neuropathic Pain and Depression.
A study testing Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFC and Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1 in people with Neuropathic Pain and Depression, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuropathic Pain, Depression
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFC and Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2024to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hélène RAINGARD, CRA contact
France1 site, 1 recruiting
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
Roland PEYRON, PhD, (0)4 77 12 78 05 ext. +33, Roland.Peyron@univ-st-etienne.fr
Roland PEYRON, PhD
About this study
Official title: Neuromodulation in Patients With Neuropathic Pain and Depression: a Cross-over Study Between Two Targets in Transcranial Magnetic Stimulation, the Primary Motor Cortex and the Dorsolateral Prefrontal Cortex.
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.
Read the detailed 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.
- Conditions
- Neuropathic Pain, Depression
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFC, Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1
- Keywords
- Neuropathic pain, Depressive Disorder, transcranial magnetic stimulation, neuromodulation, pain relief
- Medical subject headings
- Neuralgia, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFCDevice
Also called rTMS
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/M1Device
Also called rTMS
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.
| Study group | Role | What they receive |
|---|---|---|
| M1 - DLPFC | Other | Initial primary motor cortex stimulation (M1) followed by cortex prefrontal cortex (DLPFC) :
rTMS of M1, washout, rTMS of DLPFC Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFC |
| DLPFC - M1 | Other | Initial cortex prefrontal cortex (DLPFC) stimulation followed by primary motor cortex stimulation (M1) :
rTMS of DLPFC, washout, rTMS of M1 Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks after the last rTMS session for each arm
Secondary outcomes (9)
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)
Measured: 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").
Measured: 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).
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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
Measured: 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).
Measured: 2 weeks after rTMS sessions
Adverse events
Potential adverse events reporting during the study
Measured: Up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start26 Apr 2024
- Primary completionSep 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129890
- Sponsor's protocol ID
- 23CH155
- Other IDs
- ANSM
- Acronym
- DOLODEP
- Status last verified
- Jun 2025
- First submitted
- 24 Oct 2023
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation in Patients With Neuropathic Pain and Depression: a Cross-over Study Between Two Targets in Transcranial Magnetic Stimulation, the Primary Motor Cortex and the Dorsolateral Prefrontal Cortex.
- ClinicalTrials.gov ID
- NCT06129890
- Acronym / sponsor ID
- DOLODEP / 23CH155
- Conditions
- Neuropathic Pain, Depression
- Keywords
- Neuropathic pain, Depressive Disorder, transcranial magnetic stimulation, neuromodulation, pain relief
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M1 - DLPFC | Other | Device: Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFCInitial primary motor cortex stimulation (M1) followed by cortex prefrontal cortex (DLPFC) : rTMS of M1, washout, rTMS of DLPFC |
| DLPFC - M1 | Other | Device: Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1Initial cortex prefrontal cortex (DLPFC) stimulation followed by primary motor cortex stimulation (M1) : rTMS of DLPFC, washout, rTMS of M1 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFCAlso: rTMSRepetitive 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. | Device | M1 - DLPFC |
| Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1Also: rTMSRepetitive 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. | Device | DLPFC - M1 |
Primary outcome
Comparison of pain relief rates between the two stimulation targets (M1 and DLPFC)
Time frame: 2 weeks after the last rTMS session for each arm
Patients are asked how much pain relief they have experienced since the last session.
9 secondary outcomes
Neuropathic dimension
Time frame: Up to 26 weeks
Pain evolution
Time frame: Up to 26 weeks
Progression of depression (Montgomery Asberg Depression Rating Scale - MADRS)
Time frame: 2 weeks after rTMS sessions
Progression of depression (Beck Depression Inventory - BDI)
Time frame: 2 weeks after rTMS sessions
Changes in mean pain intensity
Time frame: 2 weeks after rTMS sessions
Evolution of catastrophism
Time frame: 2 weeks after rTMS sessions
Evolution of affective and sensory components of pain
Time frame: 2 weeks after rTMS sessions
Change in perceived quality of life
Time frame: 2 weeks after rTMS sessions
Adverse events
Time frame: Up to 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hélène RAINGARD, CRA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFC and Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1 in people with Neuropathic Pain and Depression, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland PEYRON, PhD ((0)4 77 12 78 05 ext. +33, roland.peyron@univ-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pain relief rates between the two stimulation targets (M1 and DLPFC) (time frame: 2 weeks after the last rTMS session for each arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.