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

Gambling Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06467422
• Other study ID #: MZhao-017
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2024
• Source: Shanghai Mental Health Center
• Contact: Tianzhen Chen, M.D, Ph.D
• Phone: 021-34773523
• Email: vomchan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Gambling
• Gambling Disorder

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activation of dACC	Activation of dACC is measured with resting-state fMRI and task fMRI.	Through the fMRI procedure
Primary	Activation of decision-making network	Activation of decision-making network is measured with resting-state fMRI and task fMRI connectivity analysis.	Through the fMRI procedure
Primary	The change of impulsivity	The change of impulsivity will be measured by sequential decision-making task.	Through the last 20 minutes of the fMRI session.
Secondary	The change of gambling craving	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.	8 minutes, 16 minutes, 24 minutes, 44 minutes of the fMRI session.