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

NCT ID: NCT06467422

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2025-06-01

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.

Conditions

Gambling Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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

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

Group Type: EXPERIMENTAL

tTIS on dACC, theta frequency (5 Hz)

Intervention Type: DEVICE

Device: Transcranial electric stimulation device

The first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2.006 kHz. According to the principle of time-domain coherence, an alternating electric field with a frequency of f2-f1 = 6 Hz can be generated in the target area. The experimental group receives a stimulation intensity of 2mA for 20 minutes. The optimal electrode position and current parameters are determined by using the MIDA head electric field model.

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

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

Group Type: SHAM_COMPARATOR

tTIS on dACC, High frequency

Intervention Type: DEVICE

The first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2 kHz. The sham group receives a stimulation intensity of 2mA for 20 minutes. The optimal electrode position and current parameters are determined by using the MIDA head electric field model.

Interventions

tTIS on dACC, theta frequency (5 Hz)

Device: Transcranial electric stimulation device

The first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2.006 kHz. According to the principle of time-domain coherence, an alternating electric field with a frequency of f2-f1 = 6 Hz can be generated in the target area. The experimental group receives a stimulation intensity of 2mA for 20 minutes. The optimal electrode position and current parameters are determined by using the MIDA head electric field model.

Intervention Type: DEVICE

tTIS on dACC, High frequency

The first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2 kHz. The sham group receives a stimulation intensity of 2mA for 20 minutes. The optimal electrode position and current parameters are determined by using the MIDA head electric field model.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Zhao, M.D, Ph.D

Role: STUDY_CHAIR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Tianzhen Chen, M.D, Ph.D

Role: CONTACT

vomchan@hotmail.com

021-34773523

Facility Contacts

Min Zhao, M.D, Ph.D

Role: primary

18017311005

Other Identifiers

MZhao-017

Identifier Type: -

Identifier Source: org_study_id