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Effects of Transcranial Temporal Interference Stimulation on Risky Decision-making and Impulse Control in Gambling Disorder

Not Applicable
Not yet recruiting
Conditions
Gambling Disorder
Interventions
Device: tTIS on dACC, theta frequency (5 Hz)
Device: tTIS on dACC, High frequency
Registration Number
NCT06467422
Lead Sponsor
Shanghai Mental Health Center
Brief Summary

The purpose of this research is to investigate the effect of transcranial temporal interference stimulation (tTIS) targeting the dorsal anterior cingulate cortex in patients with gambling disorder.

Detailed Description

This study will apply the emerging non-invasive deep brain stimulation of tTIS to the dorsal anterior cingulate cortex in a randomized, double-blind design to demonstrate the possibility of non-invasively targeting the anterior cingulate cortex to modulate impulse control and risky decision-making without activating other regions below the electrodes. Additionally, this study will combine the fMRI recordings to describe local and network effects on brain activity. Specifically, each participant will be assessed at baseline with a scale and T1WI sequence and diffusion tensor imaging, and will randomly receive a combination of stimulation sequentially during the intervention phase, with more than a one-week interval ensuring that there is no interference between each of the two stimulation sequences.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Male
Target Recruitment
30
Inclusion Criteria
  • Aged 18-60, male or female, right handed;
  • With 9 or more years of education, and able to cooperate in completing the questionnaire assessment and behavioural tests.
  • Meets the DSM-5 diagnostic criteria for gambling addiction;
  • Previous gambling behaviour of not less than 1 year's duration (at least one gambling session per week or more);
  • Normal or corrected normal vision and hearing;
  • Agrees to cooperate in completing the follow-up assessment;
  • No history of neurological problems or head injury; and no skin sensitivity.
  • Agree to cooperate in completing the follow-up assessment;
  • No metal implantation in the head, no history of neurological problems or head injury, and no skin sensitivity.
Exclusion Criteria
  • Suffering from severe cognitive dysfunction, such as a history of head trauma, cerebrovascular disease, epilepsy, etc., use of cognitive-promoting medications in the last 6 months;
  • Other psychoactive substance abuse or dependence in the last 5 years (except nicotine).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Theta Stimulation(6Hz, generated with electrodes of 2kHz and 2.005kHz)tTIS on dACC, theta frequency (5 Hz)Session1#T1(10min)+DTI(15min) Session2#rsfMRI(8min)+rsfMRI-Theta tTIs(8min)+rsfMRI(8min)+TASK fMRI-Theta TI(20min)
High Frequency Stimulation(generated with two electrodes of 2kHz)tTIS on dACC, High frequencySession1#T1(10min)+DTI(15min) Session2#rsfMRI(8min)+rsfMRI-HF tTIs(8min)+rsfMRI(8min)+TASK fMRI-HF TI(20min)
Primary Outcome Measures
NameTimeMethod
Activation of dACCThrough the fMRI procedure

Activation of dACC is measured with resting-state fMRI and task fMRI.

Activation of decision-making networkThrough the fMRI procedure

Activation of decision-making network is measured with resting-state fMRI and task fMRI connectivity analysis.

The change of impulsivityThrough the last 20 minutes of the fMRI session.

The change of impulsivity will be measured by sequential decision-making task.

Secondary Outcome Measures
NameTimeMethod
The change of gambling craving8 minutes, 16 minutes, 24 minutes, 44 minutes of the fMRI session.

Gambling craving will be measured by the gambling craving Visual Analog Scale (VAS). The total score of VAS ranged from 0 to 10, in which higher scores mean a higher level of gambling craving.

Trial Locations

Locations (1)

Shanghai Mental Health Center

🇨🇳

Shanghai, Shanghai, China

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