TBS Over DLPFC in Elderly Refractory Depression

NCT ID: NCT04872465

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-06
• Study Completion Date: 2024-07-31

Brief Summary

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.

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.

Conditions

Major Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

TBS

Intervention Type: DEVICE

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).

Sham Comparator

Participants will receive sham (placebo) TBS treatment the same as experimental group

Group Type: PLACEBO_COMPARATOR

sham

Intervention Type: DEVICE

Participants will receive sham (placebo) TBS treatment the same as experimental group

Interventions

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).

Intervention Type: DEVICE

sham

Participants will receive sham (placebo) TBS treatment the same as experimental group

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged 60 to 85 years
• Major depression disorder
• Under a stable dose of all psychotropic medication during the stimulation period.

Exclusion Criteria

• Having any current psychiatric comorbidity or history of substance dependence.
• Having active suicidal ideation currently.
• Having severe physical illness, recent and/or current unstable medical disorders.
• Having history of cancer or chemotherapy.
• Dementia or MMSE<24.
• Having TMS contraindicated (seizure disorder, history of seizures, metal in the head, pacemakers, history of craniotomy)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role: lead

Responsible Party

Che-Sheng Chu

Department of Psychiatry, MD, attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Che-Sheng Chu, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Veterans General Hospital.

Locations

Department of Psychiatry, Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Che-Sheng Chu, MD

Role: CONTACT

cschu@vghks.gov.tw

+886-7-3422121 ext. 72068

Facility Contacts

Che-Sheng Chu, MD

Role: primary

cschu@vghks.gov.tw

+886-7-3422121 ext. 72068

Other Identifiers

Kaohsiung VGHKS

Identifier Type: -

Identifier Source: org_study_id