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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-01

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sham controlled intervention

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

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

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

Theta-burst stimulation (TBS)

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

Group Type EXPERIMENTAL

TBS

Intervention Type DEVICE

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

Interventions

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TBS

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

Intervention Type DEVICE

Sham

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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No