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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized rTMS protocol | Experimental | 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. 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 programmed protocol will be delivered while a figure of eight coil will be positioned by a robotic device (Axilum Robotics). The procedure will be repeated twice a day for 10 days over 2 weeks. |
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| High frequency rTMS as usual | Active Comparator | rTMS will be performed as usual using a figure-eight coil: Defining the active motor threshold. For each session positioning the coil 5 cm ahead of the abductor pollicis brevis muscle, 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. Coil and stimulator will remain the same between individualized and "as usual" proceedures. |
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| Trans-cranial direct current stimulation (tDCS) | Active Comparator | tDCS will be performed as usual: After controlling for skin healthiness, the anode and the cathode will be respectively placed over F3 and F4. 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioning | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the target regional cerebral blood flow (rCBF) anomaly | 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). | difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol) |
| Reduction of the functional connectivity anomalies | 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). | 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 | Description | Time Frame |
|---|---|---|
| Symptoms evaluated by the clinician (QIDS16-C) | See http://www.ids-qids.org/ for documentation relative to these scales. Computation will be performed in terms of :
| 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 | Description | Time Frame |
|---|---|---|
| Response time and accuracy at the attentional network test |
| Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol) |
| Quality of life ("Echelle synoptique des 3 temps") |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jack FOUCHER, MD | Service de Psychiatrie 1, Hôpitaux Universitaires de Strasbourg | Principal Investigator |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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|
| Symptoms evaluated by the patient (QIDS30-SR) | See http://www.ids-qids.org/ for documentation relative to these scales. Computation will be performed in terms of :
| difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol) |
|
| difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol) |
| Global Assessment of Functioning |
| Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol) |
| Activity measured by an actimeter |
| Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol) |
| Acceptance of each therapeutic procedure | Feeling comfortable with the environment (visual analog scale), this will be evaluated at each stimulation | We will directly compare each therapeutic protocol by averaging this value from D1 to D12. |