e-PAT Neuromod Evaluation of Personalized rTMS for Resistant Depression

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02410421
• Other study ID #: 5055
• Status: Withdrawn
• Phase: Phase 2
• First received: April 1, 2015
• Last updated: January 4, 2016
• Est. completion date: May 2020

Study information

• Verified date: January 2016
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Treatment-Resistant

Intervention

Procedure:
• Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioning

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Outcome

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