Stimulation of Parieto-hippocampal Connectivity in Patients With Major Depressive Disorder

University Hospital Bonn (UKB)

Status: Completed

Conditions: Depressive Disorder, Major; Depressive Episode; Depression; Depressive Disorder

Treatments: Device: Add-on sham rTMS; Device: Add-on active rTMS over DLPFC; Device: Add-on active rTMS over LPC; Device: active rTMS over DLPFC

Study type: Interventional

Funder types: Other

Identifiers

NCT04081519

SHIP

Details and patient eligibility

About

This study aims to investigate the effects of individualized repetitive transcranial magnetic stimulation (rTMS) of parieto-hippocampal functional connectivity in patients with major depressive disorder (MDD). Specifically, patients will be randomized to one of three groups and will receive 15 days of rTMS over three weeks. Each day they will receive one active session of rTMS over the dorsolateral parietal cortex (DLPFC) and depending on group assignment another session either A) active rTMS over DLPFC, B) active rTMS over left and right lateral parietal cortex (LPC), or C) sham rTMS over DLPFC or LPC. Stimulation targets in the LPC will be individualized for each patient based on their resting-state functional connectivity between the hippocampus and LPC. Clinical, neuropsychological and fMRI data will be acquired before and after the treatment course.

Enrollment: 53 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• fulfilled criteria for unipolar major depressive disorder for at least four weeks
• did not respond to a minimum of one or did not tolerate a minimum of two antidepressants in the current episode

Exclusion criteria

• metal in the brain or the skull
• cardiac pacemaker or intracardiac lines
• medication infusion devices
• heart or brain surgery
• pregnancy
• substance induced depression
• history of substance abuse
• psychotic episodes
• bipolar disorder
• anorexia
• posttraumatic stress disorder (current or within the last 12 months)
• claustrophobia
• any condition resulting in increased intracranial pressure
• traumatic brain injury
• history of epilepsy
• cerebral aneurysms
• dementia
• Morbus Parkinson
• Chorea Huntington
• multiple sclerosis
• stroke or transient ischemic attack (within the last 2 years)
• previous antidepressive treatment with rTMS, electroconvulsive therapy (within the last 3 months), vagus nerve stimulation or deep brain stimulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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53 participants in 3 patient groups

DLPFC-DLPFC

Active Comparator group

Description:

15 sessions of active rTMS over DLPFC + 15 sessions of active rTMS over DLPFC

Treatment:

Device: active rTMS over DLPFC

Device: Add-on active rTMS over DLPFC

DLPFC-LPC

Experimental group

Description:

15 sessions of active rTMS over DLPFC + 15 sessions of active rTMS over LPC

Treatment:

Device: active rTMS over DLPFC

Device: Add-on active rTMS over LPC

DLPFC-SHAM

Sham Comparator group

Description:

15 sessions of active rTMS over DLPFC + 15 sessions of sham rTMS over DLPFC or LPC

Treatment:

Device: active rTMS over DLPFC

Device: Add-on sham rTMS