Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Clinical Study Coupled With Positon Emission Tomography (PET)

Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Randomized Clinical Study Coupled With Positon Emission Tomography (PET)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02559466

Enrollment

Registered

2015-09-24

Start date

2015-07-17

Completion date

2023-05-23

Last updated

2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacoresistant Depression

Keywords

pharmaco-resistant depressed patients

Brief summary

Repetitive transcranial magnetic stimulation (TMS) is an emergent non-invasive treatment for treatment resistant depression (TRD). The exact neuro-functional mechanisms related to TMS efficiency remains however unknown; besides local effect on the target, TMS may induce interaction changes between remote cerebral regions. On the other hand, few studies have been performed in comparison to sham placebo stimulation. The investigators recently showed that non-responder depressive patients to TMS exhibited deeper and wider brain functional abnormalities hardly reachable by standard coils. The H1-Coil is a novel TMS (H-TMS) device capable of inducing a magnetic field with a deeper and wider distribution than standard coils. The investigators design here a randomized controlled study in which the investigators will compare the clinical effects of H-coil TMS and standard TMS in patients with TRD, and their functional neuroanatomical correlates and changes in connectivity by Positron Emission Tomography (PET). The general objective is to better understand the mechanisms related to TMS efficiency in pharmacoresistant depression, in order to propose the best therapeutic approach for the patient.

Interventions

DEVICETranscranial Magnetic Stimulation (TMS - ) - MagPro®

Class IIa

DEVICEPositon Emission Tomography (PET) - Discovery 710®

Class IB

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients who met the diagnosis of major depressive episode (MDE) * Patient right-handed * Men and women aged over 18 years with major depressive episode IV (DSM-IV criteria), isolated or recurrent. * Scores on the scale MADRS\> 20 * Resistance Criterion defined as the failure of two antidepressants effective dose for a minimum of six weeks. * Drug Therapy stable for at least 2 weeks

Exclusion criteria

* Bipolar disorder type I or type II * Depression With Psychotic Features * Diagnosis according comorbid Axis I (DSM IV) with schizophrenia, alcohol abuse and / or toxic substances. * Inpatient under stress or under legal protection measure (guardianship, curatorship) * Counter to the practice of Transcranial Magnetic Stimulation : a personal history of seizure, history of neurological or neurosurgical pathologies, metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.). * Pregnant or breastfeeding ongoing. * Somatic disorder may affect cognitive abilities and brain structures * Known allergy to any component of Fludeoxyglucose

Design outcomes

Primary

Measure	Time frame	Description
The depression score in Montgomery-Åsberg Depression Rating Scale (MADRS).	24 month	performed before and after TMS

Secondary

Measure	Time frame
Short self-completion questionnaire on symptoms of depression	24 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026