Depressive Disorder Clinical Trial
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
NCT number | NCT02410421 |
Other study ID # | 5055 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | April 1, 2015 |
Last updated | January 4, 2016 |
Est. completion date | May 2020 |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2020 |
Est. primary completion date | May 2020 |
Accepts healthy volunteers | No |
Gender | Both |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Response time and accuracy at the attentional network test | Switch or mixed states (MAThyS) NAA/Choline and Lactate of the target (NMR spectroscopy) |
Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol) | Yes |
Other | Quality of life ("Echelle synoptique des 3 temps") | Switch or mixed states (MAThyS) NAA/Choline and Lactate of the target (NMR spectroscopy) |
difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol) | Yes |
Other | Global Assessment of Functioning | Switch or mixed states (MAThyS) NAA/Choline and Lactate of the target (NMR spectroscopy) |
Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol) | Yes |
Other | Activity measured by an actimeter | Switch or mixed states (MAThyS) NAA/Choline and Lactate of the target (NMR spectroscopy) |
Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol) | Yes |
Other | 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. | No |
Primary | 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) | No |
Primary | 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) | No |
Secondary | 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 (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol) | No |
Secondary | 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 (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol) | No |
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