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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gambling Disorder
• Intervention / Treatment: Device: tTIS on dACC, theta frequency (5 Hz); Device: tTIS on dACC, High frequency

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tianzhen Chen, M.D, Ph.D; Phone Number: 021-34773523; Email: vomchan@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai Mental Health Center
      • Contact: Min Zhao, M.D, Ph.D; Phone Number: 18017311005

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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.
Sham Comparator: 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)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activation of dACC	Activation of dACC is measured with resting-state fMRI and task fMRI.	Through the fMRI procedure
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Study Chair: Min Zhao, M.D, Ph.D, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Gambling
• Other Study ID Numbers: MZhao-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No