Study 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.
Personalized rTMS for Resistant Depression
Validation of Personalized Antidepressant Treatment by Neuromodulation - Pilot Study
1 other identifier
interventional
27
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 4, 2016
CompletedFirst Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2021
CompletedSeptember 24, 2025
September 1, 2025
4.7 years
August 2, 2016
September 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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).
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)
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)
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).
Other Outcomes (4)
Daily visual analogical scales assessing the core symptoms
Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
Response time and accuracy at the attentional network test
Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
Quality of life ("Echele synoptique des 3 temps")
Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
- +1 more other outcomes
Study Arms (3)
Individualized rTMS (transcranial magnetic stimulation)
EXPERIMENTALThe 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 COMPARATORrTMS 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 COMPARATORtDCS 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.
Interventions
Procedure consisting in personalizing the rTMS targets and stimulation pattern based on functional magnetic resonance imaging
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Psychiatrie 1, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
Related Publications (1)
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.
PMID: 40517147BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jack FOUCHER, MD
Hôpitaux Universitaires de Strasbourg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2016
First Posted
August 11, 2016
Study Start
May 4, 2016
Primary Completion
January 21, 2021
Study Completion
January 21, 2021
Last Updated
September 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share