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

National Science Council, Taiwan

Status

Completed

Conditions

Treatment

Depression

Treatments

Device: TBS

Device: Sham

Study type

Interventional

Funder types

Other

Identifiers

NCT04364880

NHRI-EX101-10144NI

Details and patient eligibility

About

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.

Full description

This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function (e.g. functional MRI, PET, and qEEG), peripheral biomarkers (e.g. candidate genetic expression, neuroendocrine, inflammation, and neurotransmissions) in MDD patients.

Enrollment

80 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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)