Neuropsychobiology of Brain Theta-burst Stimulation: A Mind-body Interface for Depression

NCT04364880 | Completed DMC

• 1 other identifier: NHRI-EX101-10144NI
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function, and peripheral biomarkers in MDD patients.

Conditions

Depression; Treatment

Keywords

depression; transcranial magnetic stimulation; theta-burst stimulation

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression (HAMD)

  The Hamilton Depression scale sum score (HAMD21) * Not depressed: 0-7 * Mild: 8-13 * Moderate: 14-18 * Severe: 19-22 * Very severe: \>23

  From Weeks 0 to 24

Secondary Outcomes (2)

• Response rate

  From Weeks 0 to 24

• Remission rate

  From Weeks 0 to 24

Study Arms (2)

Theta-burst stimulation (TBS)

EXPERIMENTAL

Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)

Device: TBS

Sham controlled intervention

SHAM COMPARATOR

The sham-TBS coil produced a similar sound without a magnetic pulse.

Device: Sham

Interventions

TBS DEVICE

Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)

Theta-burst stimulation (TBS)

Sham DEVICE

The sham-TBS coil produced a similar sound without a magnetic pulse.

Sham controlled intervention

Eligibility Criteria

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

You may qualify if:

• The diagnostic criteria of DSM-IV for MDD
• The range of the age from 18 to 70-year-old
• Physically healthy on medical history, physical examination, and laboratory parameters within normal limits
• Competent for a full explanation of the study and written informed consent is obtained.

You may not qualify if:

• Having other current Axis I disorders (except nicotine dependence), patients with psychotic disorders, bipolar disorders, organic mental disorders, and a prevailing strong suicidal risk were excluded
• Pregnant
• History or family history of seizure disorder
• Known neurological disorders or evidence of central nervous system disease based on baseline complete neurological examination, electroencephalography, and magnetic resonance imaging of the brain
• Having ferromagnetic material in the body or close to the head (implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull)

Sponsors & Collaborators

• National Science and Technology Council, Taiwan: lead

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Kuan-Pin Su, MD PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: China Medical University Hospital

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 28, 2020
• Study Start: January 1, 2012
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: October 10, 2022

Record last verified: 2022-10