Depressive Disorder Clinical Trial
Official title:
Validation of Personalized Antidepressant Treatment by Neuromodulation - Pilot Study
NCT number | NCT02863380 |
Other study ID # | 6194 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 4, 2016 |
Est. completion date | January 21, 2021 |
Verified date | March 2023 |
Source | University Hospital, Strasbourg, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 27 |
Est. completion date | January 21, 2021 |
Est. primary completion date | January 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Service de Psychiatrie 1, Hôpital Civil, Hôpitaux Universitaires de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Daily visual analogical scales assessing the core symptoms | 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 | 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). | ||
Other | Quality of life ("Echele synoptique des 3 temps") | 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 | 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). | ||
Primary | 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). |
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) | |
Primary | 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). |
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) | |
Secondary | 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). | 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). | |
Secondary | 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). | 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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