- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02559466
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)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Raphaëlle RICHIERI, PhD
- Phone Number: 0491382747
- Email: drci@ap-hm.fr
Study Locations
-
-
-
Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients stimulated with a H-TMS (deep)
20 sessions navigated with Deep Transcranial Magnetic Stimulation
|
Class IIa
Class IB
|
Other: Patients stimulated with a conventional TMS
20 sessions navigated with Conventional Transcranial Magnetic Stimulation
|
Class IIa
Class IB
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The depression score in Montgomery-Åsberg Depression Rating Scale (MADRS).
Time Frame: 24 month
|
performed before and after TMS
|
24 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Short self-completion questionnaire on symptoms of depression
Time Frame: 24 month
|
24 month
|
Collaborators and Investigators
Investigators
- Study Director: Urielle DESALBRES, Director, Assistance Publique Hopitaux de Marseille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-08
- RCAPHM15_0084 (Other Identifier: APHM)
- 2015-A00345-44 (Registry Identifier: ID RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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