Deep Versus Standard Prolonged Intermittent Theta Burst Stimulation for Depression

Summary

This study compares two types of non-invasive brain stimulation to treat major depression in patients who have not found relief from at least one antidepressant medication.

The study will use a specific type of brain stimulation called prolonged intermittent Theta Burst Stimulation (piTBS). The standard way to use piTBS for depression is to target an area on the side of the head called the dorsolateral prefrontal cortex (DLPFC). This study will compare this standard piTBS method with a newer approach, deep piTBS, which targets a different, deeper area in the middle of the brain called the anterior cingulate cortex (ACC).

Participants will be randomly assigned to one of two groups. One group will receive the deep piTBS treatment, and the other will receive the standard piTBS treatment. Both treatments are given once a day, five days a week, for four weeks. The study aims to find out if the deep piTBS approach is more effective at reducing symptoms of depression than the standard approach. Researchers will also look at effects on anxiety and other related symptoms.

Conditions

• Intermittent Theta Burst Stimulation
• Repetitive Transcranial Magnetic Stimulation
• Depression

Interventions

DEVICE

Deep Prolonged Intermittent Theta Burst Stimulation

This intervention uses a Deymed Repetitive Transcranial Magnetic Stimulator with a double-cone coil (90BFVT-LQC) to target the anterior cingulate cortex (ACC). The resting motor threshold (rMT) is determined from the tibialis anterior muscle. Stimulation is delivered at 90% of the rMT. The protocol consists of 3-pulse 50Hz bursts repeated at a 5Hz frequency, administered in cycles of 2 seconds on and 8 seconds off, for a total of 1800 pulses per session. Treatment consists of 20 sessions administered over four weeks.

DEVICE

Standard Prolonged Intermittent Theta Burst Stimulation

This intervention uses a Deymed Repetitive Transcranial Magnetic Stimulator with a planar coil (70BF-LQC) to target the left dorsolateral prefrontal cortex (DLPFC). The resting motor threshold (rMT) is determined from the abductor pollicis brevis muscle. The DLPFC is localized using Beam F3 method. Stimulation is delivered at 90% of the rMT. The protocol consists of 3-pulse 50Hz bursts repeated at a 5Hz frequency, administered in cycles of 2 seconds on and 8 seconds off, for a total of 1800 pulses per session. Treatment consists of 20 sessions administered over four weeks.

Sponsors & Collaborators

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Chia-Hao Ma, MD · Department of Psychiatry, National Taiwan University Hospital, Yunlin Branch

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-24

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• Taiwan

Study Locations