Personalized rTMS for Resistant Depression

NCT ID: NCT02863380

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-04
• Study Completion Date: 2021-01-21

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.

Conditions

Depressive Disorder; Treatment-Resistant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Functional magnetic resonance imaging used to individualize rTMS protocol

Intervention Type: PROCEDURE

Procedure consisting in personalizing the rTMS targets and stimulation pattern based on functional magnetic resonance imaging

Individualized rTMS (transcranial magnetic stimulation)

Intervention Type: 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.

Group Type: ACTIVE_COMPARATOR

Functional magnetic resonance imaging used to individualize rTMS protocol

Intervention Type: PROCEDURE

Procedure consisting in personalizing the rTMS targets and stimulation pattern based on functional magnetic resonance imaging

Classical rTMS (transcranial magnetic stimulation)

Intervention Type: 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.

Group Type: ACTIVE_COMPARATOR

Functional magnetic resonance imaging used to individualize rTMS protocol

Intervention Type: PROCEDURE

Procedure consisting in personalizing the rTMS targets and stimulation pattern based on functional magnetic resonance imaging

Classical tDCS (transcranial direct current stimulation)

Intervention Type: DEVICE

Interventions

Functional magnetic resonance imaging used to individualize rTMS protocol

Procedure consisting in personalizing the rTMS targets and stimulation pattern based on functional magnetic resonance imaging

Intervention Type: PROCEDURE

Individualized rTMS (transcranial magnetic stimulation)

Intervention Type: DEVICE

Classical rTMS (transcranial magnetic stimulation)

Intervention Type: DEVICE

Classical tDCS (transcranial direct current stimulation)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jack FOUCHER, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Service de Psychiatrie 1, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 40517147 (View on PubMed)

Other Identifiers

6194

Identifier Type: -

Identifier Source: org_study_id