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The Effect of Theta-burst Stimulation on Serum BDNF

Primary Purpose

Gambling Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Theta Burst Stimulation
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gambling Disorder focused on measuring Brain-Derived Neurotrophic Factor, Theta Burst Stimulation

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age between 20 and 65 years; fulfilling the Diagnostic and Statistical Manual version 5 (DSM-5) criteria of Major depressive disorder assessed by the Structured Clinical Interview Exclusion Criteria: Inability to provide informed consent or comprehend the study procedure; A major psychiatric illness including schizophrenia spectrum disorder, bipolar spectrum disorder, and major depressive disorder with psychotic features. A current DSM-5 diagnosis of substance use disorder except nicotine use disorder or the use of one to two low-potency benzodiazepine tablets for sleep impairment; Have known preexisting noise-induced hearing loss, concurrent treatment with ototoxic medications, or with cochlear implants. Unstable medical illness, including malignancy, uncontrolled diabetes mellitus, unstable cardiac disease or recent myocardial infarction, or cerebrovascular or cardiovascular risk factors that require intensive medical management On medications known to lower seizure threshold (e.g., TCA, bupropion, clozapine) Implants controlled by physiological signals, including pacemaker, implantable cardioverter defibrillator, cochlear implant. Metallic objects in the head, including stenting, suture. Elevated risk of seizure due to traumatic brain history, seizure history, and head trauma, intracranial lesion, and alcohol or benzodiazepines withdrawal syndrome, stimulant intoxication.

Sites / Locations

  • Taipei City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active arm

Sham arm

Arm Description

Prolonged iTBS sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks

Sham stimulation sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks

Outcomes

Primary Outcome Measures

Change in depression severity
Measured by Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Change in brain-derived neurotrophic factor (BDNF)
Serum level of BDNF

Full Information

First Posted
April 18, 2023
Last Updated
May 2, 2023
Sponsor
Taipei City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05854706
Brief Title
The Effect of Theta-burst Stimulation on Serum BDNF
Official Title
Antidepressant Effect of Prolonged Intermittent Theta-burst Stimulation on Serum Brain-derived Neurotrophic Factor Levels of Patients With Depression: A Randomized, Double-Blind, Sham-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to investigate the effect of theta burst stimulation for depression and serum brain-derived neurotrophic factor (BDNF) in individuals with major depression. The main question it aims to answer is whether 10 sessions of theta burst stimulation can influence the serum level of BDNF. Participants will be randomized into active group and sham group. Researchers will compare the level of BDNF in these groups.
Detailed Description
There is an increasing evidence that the BDNF could be involved in the mode of action of antidepressants and, perhaps, of brain stimulation. Brain stimulation methods, such as electroconvulsive therapy (ECT) has been used to treat patients with severe depression and is reported to increase BDNF levels in blood. Numerous studies has demonstrated that repetitive transcranial magnetic stimulation (rTMS) as an alternative to ECT, produced the most robust antidepressant effects, and is the most widely applied treatment protocol for major depressive disorder (MDD). Theta-burst stimulation (TBS) is a novel form of rTMS, and has recently emerged as a method with the potential to produce similar anti-depressant effects much more rapidly than traditional repetitive TMS protocols. It is presumed that BDNF mediates the therapeutic benefits of brain rTMS, but previous results are contradictory. Specific Aims: The study is a four-week randomized, double-blind, sham-controlled study comparing pre- and post-treatment serum BDNF levels of patients with MDD, who receive active or sham of prolonged intermittent TBS (piTBS) treatment. Method: During the four-week double-blind phase of active or sham piTBS treatment, piTBS sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks. Symptomatic ratings and serum BDNF measurement are administered at baseline (W0, before brain stimulation), at the end of Week 2 brain stimulation treatments, and at the two-week follow-up after the treatment (Week 4). Otherwise, the symptomatic changes are also evaluated at the end of Week 1 brain stimulation. The study include sixty patients with major depression and all participants are randomly allocated (1:1) to groups receiving either active or sham piTBS group. The aim of the present study is to explore the effect of piTBS therapy on serum BDNF levels and change of depression symptom rating scale, as well as their associations in patients with MDD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling Disorder
Keywords
Brain-Derived Neurotrophic Factor, Theta Burst Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active arm
Arm Type
Experimental
Arm Description
Prolonged iTBS sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks
Arm Title
Sham arm
Arm Type
Sham Comparator
Arm Description
Sham stimulation sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks
Intervention Type
Device
Intervention Name(s)
Theta Burst Stimulation
Intervention Description
Theta Burst Stimulation
Primary Outcome Measure Information:
Title
Change in depression severity
Description
Measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame
Before intervention (week 0) and after intervention (week 2)
Secondary Outcome Measure Information:
Title
Change in brain-derived neurotrophic factor (BDNF)
Description
Serum level of BDNF
Time Frame
Before intervention (week 0) and after intervention (week 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 20 and 65 years; fulfilling the Diagnostic and Statistical Manual version 5 (DSM-5) criteria of Major depressive disorder assessed by the Structured Clinical Interview Exclusion Criteria: Inability to provide informed consent or comprehend the study procedure; A major psychiatric illness including schizophrenia spectrum disorder, bipolar spectrum disorder, and major depressive disorder with psychotic features. A current DSM-5 diagnosis of substance use disorder except nicotine use disorder or the use of one to two low-potency benzodiazepine tablets for sleep impairment; Have known preexisting noise-induced hearing loss, concurrent treatment with ototoxic medications, or with cochlear implants. Unstable medical illness, including malignancy, uncontrolled diabetes mellitus, unstable cardiac disease or recent myocardial infarction, or cerebrovascular or cardiovascular risk factors that require intensive medical management On medications known to lower seizure threshold (e.g., TCA, bupropion, clozapine) Implants controlled by physiological signals, including pacemaker, implantable cardioverter defibrillator, cochlear implant. Metallic objects in the head, including stenting, suture. Elevated risk of seizure due to traumatic brain history, seizure history, and head trauma, intracranial lesion, and alcohol or benzodiazepines withdrawal syndrome, stimulant intoxication.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hu-Ming Chang
Phone
0978052951
Email
DAU66@tpech.gov.tw
Facility Information:
Facility Name
Taipei City Hospital
City
Taipei
State/Province
Taipei CITY
ZIP/Postal Code
105
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu-Ming Chang
Phone
0978052951
Email
DAU66@tpech.gov.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Theta-burst Stimulation on Serum BDNF

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