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

Shanghai Mental Health Center

Status: Not yet enrolling

Conditions: Gambling Disorder

Treatments: Device: tTIS on dACC, High frequency; Device: tTIS on dACC, theta frequency (5 Hz)

Study type: Interventional

Funder types: Other

Identifiers

NCT06467422

MZhao-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Theta Stimulation(6Hz, generated with electrodes of 2kHz and 2.005kHz)

Experimental group

Description:

Session1#T1(10min)+DTI(15min) Session2#rsfMRI(8min)+rsfMRI-Theta tTIs(8min)+rsfMRI(8min)+TASK fMRI-Theta TI(20min)

Treatment:

Device: tTIS on dACC, theta frequency (5 Hz)

High Frequency Stimulation(generated with two electrodes of 2kHz)

Sham Comparator group

Description:

Session1#T1(10min)+DTI(15min) Session2#rsfMRI(8min)+rsfMRI-HF tTIs(8min)+rsfMRI(8min)+TASK fMRI-HF TI(20min)

Treatment:

Device: tTIS on dACC, High frequency