TBS Over DLPFC in Elderly Refractory Depression

Overview

The study aim to examine the effect of Thea-burst stimulation over bilateral dorsolateral prefrontal cortex (DLPFC) among patients with LLD on mood condition and relevant biomarkers.

Full Title of Study: “Efficacy of Bilateral Dorsolateral Prefrontal Theta-burst Stimulation in Elderly Refractory Depression: a Randomized Sham-controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: July 31, 2024

Detailed Description

Thea-burst stimulation (TBS) is a novel form of rTMS, providing greater modulation effect on neural activity. So far, no study was conducted to use TBS as treatment in LLD. Therefore, we aim to examine the effect of TBS over bilateral dorsolateral prefrontal cortex (DLPFC) among patients with LLD on mood condition and relevant biomarkers. The study used a two-arm, parallel, double-blind, randomized, and sham-controlled design. We plan to enroll sixty patients with LLD, thirty for active intervention and thirty for sham-controlled group. An Magstim Rapid2 stimulator with eight-figure coil was used for stimulation. Location of brain area are based on bilateral DLPFC. 3-pulse 50-Hz bursts was given every 200ms (at 5 Hz) and an intensity of 80% active motor threshold was settled. We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses). Each patient received daily stimulation for two weeks with total ten sessions. The primary outcomes were change of depression severity including response and remission rate. Secondary outcome were biomarkers related to depression. Assessments were administered at baseline, immediately after 5 and 10 sessions of stimulation, and 3 months after the completion of stimulation.

Interventions

  • Device: TBS
    • We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses).
  • Device: sham
    • Participants will receive sham (placebo) TBS treatment the same as experimental group

Arms, Groups and Cohorts

  • Active Comparator: Experimental
    • We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses).
  • Placebo Comparator: Sham Comparator
    • Participants will receive sham (placebo) TBS treatment the same as experimental group

Clinical Trial Outcome Measures

Primary Measures

  • Change of depression severity including response rate
    • Time Frame: Change from baseline after 1, 2 weeks and three months
    • measured by HAMD-D
  • Change of depression severity including remission rate
    • Time Frame: Change from baseline after 1, 2 weeks and three months
    • measured by HAMD-D

Secondary Measures

  • Change of mood and sub-domains of cognition
    • Time Frame: Change from baseline after 1, 2 weeks and three months
    • Mood (depression and anxiety) Sub-domains of cognition (working memory, executive function, attention, , language, and frontal lobe function)

Participating in This Clinical Trial

Inclusion Criteria

1. Aged 60 to 85 years2. Major depression disorder3. Under four or more weeks of a stable dose of all psychotropic medication preceding randomization Exclusion Criteria:

1.Having any current psychiatric comorbidity or history of substance dependence.2.Having active suicidal ideation currently.3.Having severe physical illness, recent and/or current unstable medical disorders.4.Having history of cancer or chemotherapy.5.Dementia or MMSE<24.6.Having TMS contraindicated (seizure disorder, history of seizures, metal in the head, pacemakers, history of craniotomy)

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kaohsiung Veterans General Hospital.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Che-Sheng Chu, Department of Psychiatry, MD, attending physician – Kaohsiung Veterans General Hospital.
  • Overall Official(s)
    • Che-Sheng Chu, MD, Principal Investigator, Kaohsiung Veterans General Hospital.
  • Overall Contact(s)
    • Che-Sheng Chu, MD, +886-7-3422121, cschu@vghks.gov.tw

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