Clinical, Cognitive and Neural Effects of Potentiation of ECT by rTMS in Treatment-Resistant Depression

Major Depressive Disorder Clinical Trial

— STIMAGNECT2  

Official title:

Clinical, Cognitive and Neural Effect of Potentiation of Electroconvulsive Therapy (ECT) by Repetitive Transcranial Magnetic Stimulation (rTMS) at 10 ECT in Patients With Characterized Pharmacoresistant Depressive Episode

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06391723
• Other study ID #: 2023-A01813-42
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: Centre Hospitalier du Rouvray
• Contact: Maud Rotharmel
• Phone: +33232956825
• Email: maud.rotharmel[@]ch-lerouvray.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Electroconvulsive therapy (ECT) is one of the most effective treatments for treatment-resistant depression (TRD). However, due to response delay and cognitive impairment, ECT remains an imperfect treatment. In this multicenter, randomized, double-blind, sham-controlled study, our objective is to assess the priming effect of rTMS sessions before ECT on clinical, cognitive and neural response in patients with TRD.

Description:

80 patients with TRD will be assigned to active or sham rTMS before ECT treatment. Five sessions of active/sham rTMS will be administered over the left dorsolateral prefrontal cortex (20 Hz, 90% resting motor threshold, 20 2 s trains with 60-s intervals, 800 pulses/session) before ECT (which was active for all patients) started. Then, from the sixth ECT session, an rTMS session will occur the day before each ECT session. Clinical assessment, cognitive assessment and brain imaging (structural MRI, resting state functional MRI, MR spectroscopy) will take place before and after 10 ECT sessions. Clinical, cognitive and neural changes will be compared between both groups after 10 ECT sessions. The primary outcome will be the response rate after 10 ECT, i.e. the percentage of patients who achieved a reduction of 50% or more from their initial Hamilton Depression Scale score (HAMD-21 items).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
• HAMD score =15
• In case of unipolar disorder: no remission after at least two different antidepressants prescribed at a dose and duration sufficient for the current episode
• In the case of bipolar disorder: no remission despite lithium at an adequate plasma level combined with lamotrigine or quetiapine monotherapy at full dose
• No change of antidepressant or mood stabilizer treatment for at least 15 days
• To be rTMS-naive
• Without benzodiazepine or antiepileptic treatment for at least 15 days
• To understand spoken and written French
• Having given their informed, written consent

Exclusion Criteria:

• Contraindication to Electroconvulsive therapy (ECT), repeated Transcranial Magnetic Stimulation (rTMS), Magnetic Resonance Imaging (MRI), anesthesia
• Patients who have received ECT in the last 6 months
• Patients suffering from poorly stabilized epilepsy, serious neurological or systemic disorders
• Patients with a serious substance use disorder (other than nicotine or caffeine) according to DSM-5 criteria
• Patients suffering from severe hearing problems
• Subjects already treated with an electrical or magnetic stimulation technique
• Women who do not have adequate contraception, pregnant or breastfeeding women
• Being deprived of liberty by an administrative or judicial decision
• Patients participating or having participated in an interventional clinical trial within 30 days before the inclusion visit

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder

Intervention

Device:
• Active rTMS
rTMS will be administered over the left dorsolateral prefrontal cortex (20 Hz, 90% resting motor threshold, 20 2 s trains with 60-s intervals, 800 pulses/session)
• Sham rTMS
Sham rTMS will be administered over the left dorsolateral prefrontal cortex

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier du Rouvray	Centre Hospitalier Sainte Anne, Paris, University Hospital, Rouen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate after 10 ECT	the percentage of patients who achieved a reduction of 50% or more from their initial Hamilton Depression Scale score (HAMD-21 items)	Day 0 and Day 40
Secondary	The relative improvement of depressive symptoms throughout the study (assessed by a clinician)	the relative variation of HAMD-21	Day 0, Day 4, Day 19, Day 26, Day 40
Secondary	The relative improvement of depressive symptoms throughout the study (self-reported)	Quick Inventory of Depressive Symptomatology	Day 0, Day 4, Day 19, Day 26, Day 40
Secondary	Adverse effects	Assessment of adverse effects with the Udvalg for Kliniske Undersogelser (UKU) side effects rating scale adapted to rTMS (adapted UKU)	Day 4, Day 19, Day 26, Day 40
Secondary	Subjective assessment of memory	Scores and variations in memory assessed with the Squire Subjective Memory Questionnaire (SSMQ)	Day 4, Day 19, Day 26, Day 40
Secondary	Subjective assessment of cognitive functioning	Scores and variations in cognitive functioning assessed with the Cognitive Failures Questionnaire (CFQ)	Day 4, Day 19, Day 26, Day 40
Secondary	Global cognitive functioning (objective)	Scores and variations assessed with the Mini Mental Status Examination	Day 0 and Day 40
Secondary	Verbal memory performances (objective)	Scores and variations assessed with the RL/RI-16 test	Day 0 and Day 40
Secondary	Attention (objective)	Scores and variations assessed the D2 test of attention	Day 0 and Day 40
Secondary	Visuospatial and constructional ability (objective)	Scores and variations assessed with the Rey-Osterrieth complex figure test	Day 0 and Day 40
Secondary	Autobiographical memory (objective)	Scores and variations assessed with the autobiographical memory test (TEMPau)	Day 0 and Day 40
Secondary	Seizure threshold	Seizure threshold during ECT	Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Secondary	Seizure duration	Seizure duration during ECT	Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Secondary	Postictal Suppression	Postictal Suppression during ECT	Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Secondary	Dose of medication	Dose of medication during ECT	Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Secondary	Changes in regional gray matter density	Changes in regional gray matter density measured with 3D MRI	Day 0 and Day 40
Secondary	Changes in cortical thickness	Changes in cortical thickness measured with 3D MRI	Day 0 and Day 40
Secondary	Brain activity and biochemical changes	Changes measured with Resting state functional MRI and spectroscopy MRI	Day 0 and Day 40