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Brain-derived Neurotrophic Factor and the Antidepressant Efficacy of Brain Stimulation

NCT04076124 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-09-03

No results posted yet for this study

Summary

This study evaluates an association between brain-derived neurotrophic factor(BDNF) polymorphisms and the antidepressant efficacy of transcranial magnetic stimulation device in patients with treatment-resistant depression. In a double-blind design, All patients are randomized to three groups, i.e.repetitive transcranial magnetic stimulation treatment, intermittent theta-burst stimulation treatment or sham treatment.

Conditions

Interventions

DEVICE

Active rTMS-DLPFC

Participants in the rTMS active stimulation group will receive 4-week 10 Hz 120% of RMT to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC using a Magstim stimulator.

DEVICE

Active iTBS-DLPFC

Participants in the intermittent TBS(iTBS) active stimulation group will receive 4-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC using a Magstim stimulator.

DEVICE

Sham TBS-DLPFC or Sham rTMS-DLPFC

Half of the patients in the sham group received 4-week the same iTBS parameter stimulation (sham-iTBS), and the other half received the same rTMS parameter stimulation using a sham coil (sham-rTMS), which also improved the blinding process.

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-24
Primary Completion
2021-09-30
Completion
2021-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04076124 on ClinicalTrials.gov