The investigators hypothesize that personalizing the rTMS targets using functional MRI will increase its efficacy. The most dysfunctional regions or the most dysfunctional network will be stimulated homogeneously. Individualized rTMS will be compared to traditional rTMS procedure and to trans-cranial direct current stimulation (tDCS) in a randomized cross-over trial. In this pilot study the primary outcome measure will be the correction of the MRI anomalies. Symptoms reduction and the proportion of remitters will be secondary outcome measurements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
27
Procedure consisting in personalizing the rTMS targets and stimulation pattern based on functional magnetic resonance imaging
Service de Psychiatrie 1, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Change of rCBF anomalies
The target region will be defined by comparing the rCBF scan of the patient to a control population. rCBF will be measured using the average of 2 ∙ 3 (=6) measures of rCBF using QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. rCBF change of the target region will be compared before \& after therapeutic protocol between the different procedures (ANOVA). 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. Contrast map of each patient will be compared to the one of a control population submitted to the same analysis. Change in the number of above threshold voxels (F-test, p \< 0.05 uncorrected, extension \> 1 cm3) will be compared before \& after therapeutic procedure (ANOVA). rCBF's change of the target region will be compared before \& after therapeutic protocol between the different procedures (ANOVA).
Time frame: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
Change of the functional connectivity anomalies
The target region will be defined by comparing the rCBF scan of the patient to a control population. rCBF will be measured using the average of 2 ∙ 3 (=6) measures of rCBF using QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. rCBF change of the target region will be compared before \& after therapeutic protocol between the different procedures (ANOVA). 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. Contrast map of each patient will be compared to the one of a control population submitted to the same analysis. Change in the number of above threshold voxels (F-test, p \< 0.05 uncorrected, extension \> 1 cm3) will be compared before \& after therapeutic procedure (ANOVA). rCBF's change of the target region will be compared before \& after therapeutic protocol between the different procedures (ANOVA).
Time frame: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
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Change in 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 : percentage of symptom reduction Number responders (reduction of more than 50% of symptoms) \& numbers of remitters (QIDS16-C ≤ 6).
Time frame: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
Change in 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 : percentage of symptom reduction Number responders (reduction of more than 50% of symptoms) \& numbers of remitters (QIDS16-C ≤ 6).
Time frame: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).