跳至主要内容
临床试验/NCT06467422
NCT06467422尚未招募不适用

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

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Activation of dACC

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Activation of dACC

时间窗: Through the fMRI procedure

Activation of dACC is measured with resting-state fMRI and task fMRI.

Activation of decision-making network

时间窗: Through the fMRI procedure

Activation of decision-making network is measured with resting-state fMRI and task fMRI connectivity analysis.

The change of impulsivity

时间窗: Through the last 20 minutes of the fMRI session.

The change of impulsivity will be measured by sequential decision-making task.

次要结局

  • The change of gambling craving(8 minutes, 16 minutes, 24 minutes, 44 minutes of the fMRI session.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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