Personalized rTMS for Resistant Depression

Depressive Disorder Clinical Trial

Official title:

Validation of Personalized Antidepressant Treatment by Neuromodulation - Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02863380
• Other study ID #: 6194
• Status: Terminated
• Phase: N/A
• Start date: May 4, 2016
• Est. completion date: January 21, 2021

Study information

• Verified date: March 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Depressive Disorder
• Treatment-Resistant

Intervention

Procedure:
• Functional magnetic resonance imaging used to individualize rTMS protocol
Procedure consisting in personalizing the rTMS targets and stimulation pattern based on functional magnetic resonance imaging

Device:
• Individualized rTMS (transcranial magnetic stimulation)

• Classical rTMS (transcranial magnetic stimulation)

• Classical tDCS (transcranial direct current stimulation)

Locations

Country	Name	City	State
France	Service de Psychiatrie 1, Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

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).