NCT04486222

Accelerated Bilateral rTMS on Geriatric Depression

Therapeutic Effect of Accelerated Bilateral Repeated Transcranial Magnetic Stimulation on Geriatric Depression: a Prospective Double-blind, Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy of accelerated bilateral repetitive transcranial magnetic stimulation (rTMS) on major depression, anxiety, cognitive function and physiological parameters in elderly depressive patients.

Detailed description

Repeated transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation treatment, showing good therapeutic effect to medicine treatment-refractory patients. Recent studies suggested bilateral DLPFC might be effective to geriatric depression. Accelerated treatment course was reported to have similar therapeutic effect and safety profile with traditional course. The investigators hypothesize accelerated bilateral rTMS is effective to geriatric depression and comorbid anxiety. Cognitive impairment and decreased parasympathetic tone are common in patients with major depression. The investigators hypothesize cognitive function and physiological indicators improve after accelerated bilateral rTMS. In this single-center, prospective double-blind, randomized, active-controlled trial, the investigators aim to recruit 100 patients older than 60 years, without neurocognitive disorders, and refractory to one or more antidepressants. The experimental group would receive an rTMS course with high-frequency stimulation at left DLPFC followed by low-frequency inhibition at right DLPFC, two sessions daily, five days a week, and two weeks in total. The standard treatment group would receive an rTMS course with high-frequency stimulation at left DLPFC as standard treatment parameters. Mood, cognition and physiological markers would be monitored every week. The primary outcome is response and remission rate of major depression measured by Hamilton Rating Scale for Depression.

Conditions

• Transcranial Magnetic Stimulation
• Depressive Disorder, Major

Interventions

Type	Name	Description
DEVICE	Repeated Transcranial Magnetic Stimulation	Magstim® Super Rapid² Transcranial Magnetic Stimulation System

Timeline

• Start date: 2020-11-23
• Primary completion: 2022-12-21
• Completion: 2022-12-21
• First posted: 2020-07-24
• Last updated: 2023-01-04

Locations

1 site across 1 country: Taiwan