Depressive DisorderNCT02863380
Personalized rTMS for Resistant Depression
A study testing Functional magnetic resonance imaging used to individualize rTMS protocol, Individualized rTMS (transcranial magnetic stimulation) and Classical rTMS (transcranial magnetic stimulation) in people with Depressive Disorder and Treatment-Resistant, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The investigators hypothesize that personalizing the rTMS targets using functional MRI will increase its efficacy. The most dysfunctional regions or the most dysfunctional network will be stimulated homogeneously. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Treatment-Resistant
- What is being tested?
- Functional magnetic resonance imaging used to individualize rTMS protocol, Individualized rTMS (transcranial magnetic stimulation) and Classical rTMS (transcranial magnetic stimulation)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2016to 21 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 65 Y
- Affiliated to the health insurance
- Having signed an informed consent
- Suffering from major depression according to the DSM5
- Unresponsive or incomplete remission after at least one trial of antidepressant (> 6 weeks at efficient dose or side effects)
- Treatment stable for > 6 weeks
Who cannot join
- Contraindication for MRI, rTMS or tDCS: non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump clip or vascular stent, heart valve or ventricular shunt, seizure disorders, skin pathology in the region of tDCS electrode placement.
- Pregnancy
- Severe and non-stabilized somatic pathology
- Patients deprived of liberty or hospitalized without their consent
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Psychiatrie 1, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Validation of Personalized Antidepressant Treatment by Neuromodulation - Pilot Study
The investigators hypothesize that personalizing the rTMS targets using functional MRI will increase its efficacy. The most dysfunctional regions or the most dysfunctional network will be stimulated homogeneously. Individualized rTMS will be compared to traditional rTMS procedure and to trans-cranial direct current stimulation (tDCS) in a randomized cross-over trial.
In this pilot study the primary outcome measure will be the correction of the MRI anomalies. Symptoms reduction and the proportion of remitters will be secondary outcome measurements.
- Conditions
- Depressive Disorder, Treatment-Resistant
- Being tested
- Functional magnetic resonance imaging used to individualize rTMS protocol, Individualized rTMS (transcranial magnetic stimulation), Classical rTMS (transcranial magnetic stimulation), Classical tDCS (transcranial direct current stimulation)
- Keywords
- Individualized Medicine, Transcranial Magnetic Stimulation, Repetitive, Transcranial Direct Current Stimulation Monocentric, Compariative Cross-Over 3 Arms Study Randomized, Single-Blind Method, Functional Neuroimaging
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional magnetic resonance imaging used to individualize rTMS protocolProcedure or surgery
Procedure consisting in personalizing the rTMS targets and stimulation pattern based on functional magnetic resonance imaging
Individualized rTMS (transcranial magnetic stimulation)Device
Classical rTMS (transcranial magnetic stimulation)Device
Classical tDCS (transcranial direct current stimulation)Device
| Study group | Role | What they receive |
|---|---|---|
| Individualized rTMS (transcranial magnetic stimulation) | Experimental | The target region will be defined by comparing the rCBF scan of the patient to a control population (n = 38). rCBF will be measured using the QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio.
The therapeutic protocol will be design to correct the rCBF anomaly first by defining each point where to deliver the stimulation than the stimulation protocol for each point (180% of active motor threshold, 4-second 10 Hz train duration, with 26-second intertrain interval for a total of 3000 pulses). The whole target will be homogeneously stimulated.
The active motor threshold will be assessed. The procedure will be repeated twice a day for 10 days over 2 weeks. Receives: Procedure: Functional magnetic resonance imaging used to individualize rTMS protocol; Device: Individualized rTMS (transcranial magnetic stimulation) |
| Classical rTMS (transcranial magnetic stimulation) | Active comparator | rTMS will be performed as usual using a figure-eight coil: Defining the active motor threshold. For each session positioning the coil on F3, stimulating at 180% of active motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session), twice a day for 10 days over 2 weeks. Receives: Procedure: Functional magnetic resonance imaging used to individualize rTMS protocol; Device: Classical rTMS (transcranial magnetic stimulation) |
| Classical tDCS (transcranial direct current stimulation) | Active comparator | tDCS will be performed as usual: After controlling for skin healthiness, the anode and the cathode will be respectively placed over F3 and right shoulder. A commercial devices (MagStim), will deliver a constant current of 2 mA through 25 cm2 saline-soaked rubber sponges for 20 min per session. The procedure will be repeated twice a day for 10 days over 2 weeks. Receives: Procedure: Functional magnetic resonance imaging used to individualize rTMS protocol; Device: Classical tDCS (transcranial direct current stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of rCBF anomalies
The target region will be defined by comparing the rCBF scan of the patient to a control population. rCBF will be measured using the average of 2 ∙ 3 (=6) measures of rCBF using QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. rCBF change of the target region will be compared before \& after therapeutic protocol between the different procedures (ANOVA).
Functional connectivity map of the target region will be performed by extracting its average temporal course and looking at the region(s) which activity is correlated. Contrast map of each patient will be compared to the one of a control population submitted to the same analysis. Change in the number of above threshold voxels (F-test, p < 0.05 uncorrected, extension > 1 cm3) will be compared before \& after therapeutic procedure (ANOVA). rCBF's change of the target region will be compared before \& after therapeutic protocol between the different procedures (ANOVA).
Measured: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
Change of the functional connectivity anomalies
The target region will be defined by comparing the rCBF scan of the patient to a control population. rCBF will be measured using the average of 2 ∙ 3 (=6) measures of rCBF using QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. rCBF change of the target region will be compared before \& after therapeutic protocol between the different procedures (ANOVA).
Functional connectivity map of the target region will be performed by extracting its average temporal course and looking at the region(s) which activity is correlated. Contrast map of each patient will be compared to the one of a control population submitted to the same analysis. Change in the number of above threshold voxels (F-test, p < 0.05 uncorrected, extension > 1 cm3) will be compared before \& after therapeutic procedure (ANOVA). rCBF's change of the target region will be compared before \& after therapeutic protocol between the different procedures (ANOVA).
Measured: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
Secondary outcomes (2)
Change in symptoms evaluated by the clinician (QIDS16-C)
See http://www.ids-qids.org/ for documentation relative to these scales. Computation will be performed in terms of : percentage of symptom reduction Number responders (reduction of more than 50% of symptoms) \& numbers of remitters (QIDS16-C ≤ 6).
Measured: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
Change in symptoms evaluated by the patient (QIDS30-SR)
See http://www.ids-qids.org/ for documentation relative to these scales. Computation will be performed in terms of : percentage of symptom reduction Number responders (reduction of more than 50% of symptoms) \& numbers of remitters (QIDS16-C ≤ 6).
Measured: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start4 May 2016
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
Why it stopped: The research objectives are achieved, demonstrating the feasibility and superiority of the personalized approach. It was no longer justified to continue the inclusions in this 'proof of concept' type study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jack FOUCHER, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863380
- Sponsor's protocol ID
- 6194
- Status last verified
- Sep 2025
- First submitted
- 2 Aug 2016
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dormegny-Jeanjean LC, de Crespin de Billy C, Pierrat C, Mainberger O, Schorr B, Obrecht A, Arcay H, Moreau A, Humbert I, Scarlatti F, Bertschy G, de Sousa PL, Lamy J, Weibel S, Landre L, Foucher JR. Individualizing rTMS in treatment-resistant depression from patient-specific perfusion abnormalities a proof-of-concept randomized trial in comparison to standard rTMS and tDCS. Eur Arch Psychiatry Clin Neurosci. 2025 Sep;275(6):1809-1825. doi: 10.1007/s00406-025-02027-7. Epub 2025 Jun 14.
PubMed 40517147
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Personalized Antidepressant Treatment by Neuromodulation - Pilot Study
- ClinicalTrials.gov ID
- NCT02863380
- Acronym / sponsor ID
- 6194
- Conditions
- Depressive Disorder, Treatment-Resistant
- Keywords
- Individualized Medicine, Transcranial Magnetic Stimulation, Repetitive, Transcranial Direct Current Stimulation Monocentric, Compariative Cross-Over 3 Arms Study Randomized, Single-Blind Method, Functional Neuroimaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The research objectives are achieved, demonstrating the feasibility and superiority of the personalized approach. It was no longer justified to continue the inclusions in this 'proof of concept' type study.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 May 2016 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 11 Aug 2016 (estimated)
- 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.
The investigators hypothesize that personalizing the rTMS targets using functional MRI will increase its efficacy. The most dysfunctional regions or the most dysfunctional network will be stimulated homogeneously. Individualized rTMS will be compared to traditional rTMS procedure and to trans-cranial direct current stimulation (tDCS) in a randomized cross-over trial.
In this pilot study the primary outcome measure will be the correction of the MRI anomalies. Symptoms reduction and the proportion of remitters will be secondary outcome measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individualized rTMS (transcranial magnetic stimulation) | Experimental | Procedure: Functional magnetic resonance imaging used to individualize rTMS protocol, Device: Individualized rTMS (transcranial magnetic stimulation)The target region will be defined by comparing the rCBF scan of the patient to a control population (n = 38). rCBF will be measured using the QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. The therapeutic protocol will be design to correct the rCBF anomaly first by defining each point where to deliver the stimulation than the stimulation protocol for each point (180% of active motor threshold, 4-second 10 Hz train duration, with 26-second intertrain interval for a total of 3000 pulses). The whole target will be homogeneously stimulated. The active motor threshold will be assessed. The procedure will be repeated twice a day for 10 days over 2 weeks. |
| Classical rTMS (transcranial magnetic stimulation) | Active comparator | Procedure: Functional magnetic resonance imaging used to individualize rTMS protocol, Device: Classical rTMS (transcranial magnetic stimulation)rTMS will be performed as usual using a figure-eight coil: Defining the active motor threshold. For each session positioning the coil on F3, stimulating at 180% of active motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session), twice a day for 10 days over 2 weeks. |
| Classical tDCS (transcranial direct current stimulation) | Active comparator | Procedure: Functional magnetic resonance imaging used to individualize rTMS protocol, Device: Classical tDCS (transcranial direct current stimulation)tDCS will be performed as usual: After controlling for skin healthiness, the anode and the cathode will be respectively placed over F3 and right shoulder. A commercial devices (MagStim), will deliver a constant current of 2 mA through 25 cm2 saline-soaked rubber sponges for 20 min per session. The procedure will be repeated twice a day for 10 days over 2 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged from 18 to 65 Y
- Affiliated to the health insurance
- Having signed an informed consent
- Suffering from major depression according to the DSM5
- Unresponsive or incomplete remission after at least one trial of antidepressant (> 6 weeks at efficient dose or side effects)
Key exclusion criteria (4 listed)
- Contraindication for MRI, rTMS or tDCS: non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump clip or vascular stent, heart valve or ventricular shunt, seizure disorders, skin pathology in the region of tDCS electrode placement.
- Pregnancy
- Severe and non-stabilized somatic pathology
- Patients deprived of liberty or hospitalized without their consent
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 |
|---|---|---|
| Functional magnetic resonance imaging used to individualize rTMS protocolProcedure consisting in personalizing the rTMS targets and stimulation pattern based on functional magnetic resonance imaging | Procedure or surgery | Classical rTMS (transcranial magnetic stimulation), Classical tDCS (transcranial direct current stimulation), Individualized rTMS (transcranial magnetic stimulation) |
| Individualized rTMS (transcranial magnetic stimulation) | Device | Individualized rTMS (transcranial magnetic stimulation) |
| Classical rTMS (transcranial magnetic stimulation) | Device | Classical rTMS (transcranial magnetic stimulation) |
| Classical tDCS (transcranial direct current stimulation) | Device | Classical tDCS (transcranial direct current stimulation) |
Primary outcome
Change of rCBF anomalies
Time frame: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
The target region will be defined by comparing the rCBF scan of the patient to a control population. rCBF will be measured using the average of 2 ∙ 3 (=6) measures of rCBF using QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. rCBF change of the target region will be compared before \& after therapeutic protocol between the different procedures (ANOVA). Functional connectivity map of the target region will be performed by extracting its average temporal course and looking at the region(s) which activity is correlated. Contrast map of each patient will be compared to the one of a control population submitted to the same analysis. Change in the number of above threshold voxels (F-test, p < 0.05 uncorrected, extension > 1 cm3) will be compared before \& after therapeutic procedure (ANOVA). rCBF's change of the target region will be compared before \& after therapeutic protocol between the different procedures (ANOVA).
Change of the functional connectivity anomalies
Time frame: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
The target region will be defined by comparing the rCBF scan of the patient to a control population. rCBF will be measured using the average of 2 ∙ 3 (=6) measures of rCBF using QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. rCBF change of the target region will be compared before \& after therapeutic protocol between the different procedures (ANOVA). Functional connectivity map of the target region will be performed by extracting its average temporal course and looking at the region(s) which activity is correlated. Contrast map of each patient will be compared to the one of a control population submitted to the same analysis. Change in the number of above threshold voxels (F-test, p < 0.05 uncorrected, extension > 1 cm3) will be compared before \& after therapeutic procedure (ANOVA). rCBF's change of the target region will be compared before \& after therapeutic protocol between the different procedures (ANOVA).
2 secondary outcomes
Change in symptoms evaluated by the clinician (QIDS16-C)
Time frame: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
Change in symptoms evaluated by the patient (QIDS30-SR)
Time frame: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
Results and safety
The study was stopped early (reason given: The research objectives are achieved, demonstrating the feasibility and superiority of the personalized approach. It was no longer justified to continue the inclusions in this 'proof of concept' type study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Background: PubMed 40517147Dormegny-Jeanjean LC, de Crespin de Billy C, Pierrat C, Mainberger O, Schorr B, Obrecht A, Arcay H, Moreau A, Humbert I, Scarlatti F, Bertschy G, de Sousa PL, Lamy J, Weibel S, Landre L, Foucher JR. Individualizing rTMS in treatment-resistant depression from patient-specific perfusion abnormalities a proof-of-concept randomized trial in comparison to standard rTMS and tDCS. Eur Arch Psychiatry Clin Neurosci. 2025 Sep;275(6):1809-1825. doi: 10.1007/s00406-025-02027-7. Epub 2025 Jun 14.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jack FOUCHER, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional magnetic resonance imaging used to individualize rTMS protocol, Individualized rTMS (transcranial magnetic stimulation) and Classical rTMS (transcranial magnetic stimulation) in people with Depressive Disorder and Treatment-Resistant, run by University Hospital, Strasbourg, France 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 24 Sep 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?
The study was stopped early (reason given: The research objectives are achieved, demonstrating the feasibility and superiority of the personalized approach. It was no longer justified to continue the inclusions in this 'proof of concept' type study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of rCBF anomalies (time frame: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02863380, which also lists 1 linked publication.
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 24 Sep 2025.