Clinical trial NCT06467422: Effects of Transcranial Temporal Interference Stimulation on Risky Decision-making and Impulse Control in Gambling Disorder
Official title: Exploring the Role and Neural Mechanisms of Transcranial Temporal Interference Stimulation Modulating the Dorsal Anterior Cingulate Cortex on Risky Decision-making and Impulse Control in Gambling Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gambling Disorder
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Activation of dACC
timeFrame: Through the fMRI procedure
measure: Activation of decision-making network
timeFrame: Through the fMRI procedure
measure: The change of impulsivity
timeFrame: Through the last 20 minutes of the fMRI session.
Secondary outcomes:
measure: The change of gambling craving
timeFrame: 8 minutes, 16 minutes, 24 minutes, 44 minutes of the fMRI session.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Min Zhao, M.D, Ph.D
role: STUDY_CHAIR
References: