Clinical trial NCT02410421: e-PAT Neuromod Evaluation of Personalized rTMS for Resistant Depression
Official title: Validation of Individualized rTMS Protocol Using Non Invasive Functional Brain Imaging and Robotic Coil Placement in Resistant Depression: Comparison With Classical rTMS and tDCS
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Depressive Disorder
Treatment-Resistant
Keywords: Individualized Medicine
Functional Neuroimaging
Robotic Proceedure
Transcranial Magnetic Stimulation, Repetitive
Transcranial Direct Current Stimulation Monocentric
Compariative Cross-Over 3 Arms Study Randomized, Single-Blind Method
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Although repetitive trans-cranial magnetic stimulation (rTMS) is an effective therapy for resistant depression, it still fail to remit up to 70% of these patients. We hypothesize that personalizing the procedure using functional MRI to better select dysfunctional regions and robotic coil placement to stimulate these regions homogeneously, will increase its efficacy. Individualized rTMS will be compared to traditional rTMS procedure and to trans-cranial direct current stimulation (tDCS).

In this small proof of principle study our primary outcome measure will be the correction of the MRI anomalies. Symptoms reduction and the proportion of remitters will be secondary outcome measurements.


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

Primary outcomes:
measure: Reduction of the target regional cerebral blood flow (rCBF) anomaly
timeFrame: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
measure: Reduction of the functional connectivity anomalies
timeFrame: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
Secondary outcomes:
measure: Symptoms evaluated by the clinician (QIDS16-C)
timeFrame: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
measure: Symptoms evaluated by the patient (QIDS30-SR)
timeFrame: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
Other outcomes:
measure: Response time and accuracy at the attentional network test
timeFrame: Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
measure: Quality of life ("Echelle synoptique des 3 temps")
timeFrame: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
measure: Global Assessment of Functioning
timeFrame: Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
measure: Activity measured by an actimeter
timeFrame: Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
measure: Acceptance of each therapeutic procedure
timeFrame: We will directly compare each therapeutic protocol by averaging this value from D1 to D12.
Locations:
Study officials:
affiliation: Service de Psychiatrie 1, Hôpitaux Universitaires de Strasbourg
name: Jack FOUCHER, MD
role: PRINCIPAL_INVESTIGATOR
References: