e-PAT Neuromod Evaluation of Personalized rTMS for Resistant Depression

Phase 2

Withdrawn

• Conditions: Depressive Disorder; Treatment-Resistant

• Registration Number: NCT02410421
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-05
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Reduction of the target regional cerebral blood flow (rCBF) anomaly	difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)	The target region will be defined by comparing the rCBF scan of the patient to a control population (n = 80). rCBF will be measured using the QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. We will compare the average rCBF of the target region before and after the therapeutic protocol between the different procedures (ANOVA).
Reduction of the functional connectivity anomalies	difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)	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 (smoothed by a 8 mm Gaussian kernel). The contrast map of each patient will be compared to the one of a control population submitted to the same analysis. We will compare the number of above threshold voxels (F-test, p \< 0.05 uncorrected, extension \> 1 cm3) before and after the therapeutic procedure (ANOVA). We will compare the average rCBF of the target region before and after the therapeutic protocol between the different procedures (ANOVA).

Secondary Outcome Measures

Name	Time	Method
Symptoms evaluated by the patient (QIDS30-SR)	difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)	See http://www.ids-qids.org/ for documentation relative to these scales.; Computation will be performed in terms of : * Percentage of symptom reduction; * Number responders (reduction of more than 50% of symptoms); * Numbers of remitters (QIDS16-C ≤ 6).
Symptoms evaluated by the clinician (QIDS16-C)	difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)	See http://www.ids-qids.org/ for documentation relative to these scales.; Computation will be performed in terms of : * Percentage of symptom reduction; * Number responders (reduction of more than 50% of symptoms); * Numbers of remitters (QIDS16-C ≤ 6).