Deep Versus Standard Prolonged Intermittent Theta Burst Stimulation for Depression

NCT07198438 | Enrolling By Invitation

• 1 other identifier: 202506034RINB
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Depression; Repetitive Transcranial Magnetic Stimulation; Intermittent Theta Burst Stimulation

Keywords

Repetitive Transcranial Magnetic Stimulation; intermittent theta burst stimulation; depression

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D17) Score

  The 17-item Hamilton Depression Rating Scale (HAM-D17) is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is derived from a structured interview conducted by a trained outcomes assessor who is blinded to the participant's treatment group. Scores range from 0-52, where higher scores indicate more severe depression.

  Baseline (Day 1, prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.

Secondary Outcomes (11)

• Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A) Score

  Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.

• Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score

  Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.

• Change From Baseline in the Beck Depression Inventory-II (BDI-II) Score

  Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.

• Change From Baseline in the Beck Anxiety Inventory (BAI) Score

  Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.

• Change From Baseline in the Young Mania Rating Scale (YMRS) Score

  Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.

Study Arms (2)

Deep piTBS

EXPERIMENTAL

Participants assigned to the experimental group receive prolonged intermittent theta burst stimulation (piTBS) with a double-cone coil targeting the anterior cingulate cortex (ACC).

Device: Deep Prolonged Intermittent Theta Burst Stimulation

Standard piTBS

ACTIVE COMPARATOR

Participants assigned to the active comparator group receive prolonged intermittent theta burst stimulation (piTBS) with a planar coil targeting the left dorsolateral prefrontal cortex (DLPFC).

Device: Standard Prolonged Intermittent Theta Burst Stimulation

Interventions

Standard Prolonged Intermittent Theta Burst Stimulation DEVICE

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.

Standard piTBS

Deep Prolonged Intermittent Theta Burst Stimulation DEVICE

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.

Deep piTBS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages between 18 and 70 years, inclusive.
• Diagnosis of Major Depressive Disorder (MDD) with a current major depressive episode, according to DSM-5 criteria, as confirmed by a psychiatrist.
• History of inadequate response to at least one trial of an antidepressant medication of adequate dose and duration.
• A score of 18 or greater on the 17-item Hamilton Depression Rating Scale (HAM-D17) at the screening visit.

You may not qualify if:

• Lifetime diagnosis of any primary psychotic disorder (e.g., schizophrenia spectrum disorders) or bipolar and related disorders according to DSM-5.
• Significant current suicide risk, as indicated by a score of 4 on item 3 of the HAM-D17.
• Current substance use disorder (excluding tobacco) within the last 3 months, according to DSM-5.
• Presence of significant cognitive impairment, such as intellectual disability, delirium, or a diagnosed neurocognitive disorder.
• Any personal history of seizures, stroke, brain tumor, brain aneurysm, increased intracranial pressure, or other major neurological disorders.
• Presence of metal implants in the head (excluding dental fillings) or any implanted medical devices such as a cardiac pacemaker or defibrillator.
• Currently pregnant.
• Any other major medical condition that, in the investigator's judgment, could compromise participant safety or interfere with the study procedures.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Psychiatry, National Taiwan University Hospital, Yunlin Branch

Douliu, Yunlin County, 640, Taiwan

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Chia-Hao Ma, MD

  Department of Psychiatry, National Taiwan University Hospital, Yunlin Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The raters for the primary and key secondary outcome scales (including HAM-D17, HAM-A, YMRS, and Y-BOCS) are blinded to the participant's treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: September 30, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 11, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)