NCT05872750

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Apr 2023Jun 2026

Study Start

First participant enrolled

April 17, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

3.1 years

First QC Date

May 3, 2023

Last Update Submit

May 14, 2023

Conditions

Gambling Disorder

Keywords

theta burst stimulationGambling Disorder

Outcome Measures

Primary Outcomes (2)

  • Change in gambling craving

    Measured by visual analog scale, from 0-10

    Before intervention (week 0) and after intervention (week 2, 4)

  • Change in gambling severity

    Measured by Gambling Symptom Assessment Scale, from 0-48

    Before intervention (week 0) and after intervention (week 2, 4)

Secondary Outcomes (2)

  • Change in depression severity

    Before intervention (week 0) and after intervention (week 2, 4)

  • Change in anxiety severity

    Before intervention (week 0) and after intervention (week 2, 4)

Study Arms (2)

Active arm

EXPERIMENTAL

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

Device: theta burst stimulation

Sham arm

SHAM COMPARATOR

the control group will receive sham stimulation

Device: sham stimulation

Interventions

theta burst stimulationDEVICE

Magstim Rapid 2 Plus stimulator (Magstim Co., Ltd., Whitland, United Kingdom)

Active arm
sham stimulationDEVICE

sham stimulation

Sham arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, Taipei CITY, 105, Taiwan

RECRUITING

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Officials

  • Hu-Ming Chang

    Taipei City Psychiatric Center, Taipei City Hospital, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hu-Ming Chang

CONTACT

0978052951DAU66@tpech.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: theta burst stimulation
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 24, 2023

Study Start

April 17, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)