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Theta Burst Stimulation for Gambling Disorder

Primary Purpose

Gambling Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
theta burst stimulation
sham 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 theta burst stimulation, Gambling Disorder

Eligibility Criteria

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

Inclusion Criteria: age between 18 and 65 years; fulfilling at least 4 of the Diagnostic and Statistical Manual version 5 (DSM-5) criteria of gambling disorder for at least 12-month assessed by the Structured Clinical Interview Exclusion Criteria: Inability to provide informed consent or comprehend the study procedure; A major psychiatric illness that required chronic psychotropic medication or inpatient treatment, 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

The intervention group will receive repetitive transcranial magnetic stimulation at the left dorsolateral prefrontal cortex and pre-supplementary motor area

the control group will receive sham stimulation

Outcomes

Primary Outcome Measures

Change in gambling craving
Measured by visual analog scale, from 0-10
Change in gambling severity
Measured by Gambling Symptom Assessment Scale, from 0-48

Secondary Outcome Measures

Change in depression severity
Measured by Beck Depression Inventory, from 0-63
Change in anxiety severity
Measured by Beck Anxiety Inventory, from 0-63

Full Information

First Posted
May 3, 2023
Last Updated
May 14, 2023
Sponsor
Taipei City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05872750
Brief Title
Theta Burst Stimulation for Gambling Disorder
Official Title
Rolling Deep With Gambling Disorder: From Building up of Scales, Biomarkers to Therapeutic Innovation
Study Type
Interventional

2. Study Status

Record Verification Date
May 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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to investigate the efficacy of theta burst stimulation in individuals with gambling disorder. The main goal is to compare the severity of gambling problems following 2 weeks of intervention between active group and sham group. Participants will be randomized into active and sham group. The severity of gambling problems are assessed by self-reported questionaires.
Detailed Description
Gambling disorder, formerly known as pathological gambling, is a gambling behavior that causes significant function impairment in personal, social, occupational domains. Currently there is no pharmacological treatment for gambling disorder and it is urgent to develop innovative treatment modalities. Image studies have found a link between prefrontal circuit dysfunction and behavioral disinhibition, which supports the use of non-invasive brain stimulation as a potential treatment for gambling disorder. In this study, 75 patients with gambling disorder will be randomly assigned in a 2:1 ratio to the intervention group (50 patients) and the control group (25 patients) on double-blind basis. The study duration is 2 weeks, with 10 sessions of 20 minutes each. The intervention group will receive repetitive transcranial magnetic stimulation at the left dorsolateral prefrontal cortex and pre-supplementary motor area, while the control group will receive sham stimulation. The Chinese version of the Problem Gambling Severity Index (PGSI), the Gambling Symptom Assessment Scale (G-SAS), and the Visual Analogue Scale (VAS) for craving will be administered at week 0, 2, 4, 8, and the change in gambling severity between the two groups will be compared by repeated measures ANOVA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling Disorder
Keywords
theta burst stimulation, Gambling Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
theta burst stimulation
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active arm
Arm Type
Experimental
Arm Description
The intervention group will receive repetitive transcranial magnetic stimulation at the left dorsolateral prefrontal cortex and pre-supplementary motor area
Arm Title
Sham arm
Arm Type
Sham Comparator
Arm Description
the control group will receive sham stimulation
Intervention Type
Device
Intervention Name(s)
theta burst stimulation
Intervention Description
Magstim Rapid 2 Plus stimulator (Magstim Co., Ltd., Whitland, United Kingdom)
Intervention Type
Device
Intervention Name(s)
sham stimulation
Intervention Description
sham stimulation
Primary Outcome Measure Information:
Title
Change in gambling craving
Description
Measured by visual analog scale, from 0-10
Time Frame
Before intervention (week 0) and after intervention (week 2, 4)
Title
Change in gambling severity
Description
Measured by Gambling Symptom Assessment Scale, from 0-48
Time Frame
Before intervention (week 0) and after intervention (week 2, 4)
Secondary Outcome Measure Information:
Title
Change in depression severity
Description
Measured by Beck Depression Inventory, from 0-63
Time Frame
Before intervention (week 0) and after intervention (week 2, 4)
Title
Change in anxiety severity
Description
Measured by Beck Anxiety Inventory, from 0-63
Time Frame
Before intervention (week 0) and after intervention (week 2, 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 18 and 65 years; fulfilling at least 4 of the Diagnostic and Statistical Manual version 5 (DSM-5) criteria of gambling disorder for at least 12-month assessed by the Structured Clinical Interview Exclusion Criteria: Inability to provide informed consent or comprehend the study procedure; A major psychiatric illness that required chronic psychotropic medication or inpatient treatment, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hu-Ming Chang
Organizational Affiliation
Taipei City Psychiatric Center, Taipei City Hospital, Taipei, Taiwan
Official's Role
Principal Investigator
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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Theta Burst Stimulation for Gambling Disorder

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