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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06467422
Enrollment
30
Registered
2024-06-21
Start date
2024-06-20
Completion date
2025-06-01
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gambling Disorder

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.

Interventions

DEVICEtTIS 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.

DEVICEtTIS 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.

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Activation of dACCThrough the fMRI procedureActivation of dACC is measured with resting-state fMRI and task fMRI.
Activation of decision-making networkThrough the fMRI procedureActivation of decision-making network is measured with resting-state fMRI and task fMRI connectivity analysis.
The change of impulsivityThrough the last 20 minutes of the fMRI session.The change of impulsivity will be measured by sequential decision-making task.

Secondary

MeasureTime frameDescription
The change of gambling craving8 minutes, 16 minutes, 24 minutes, 44 minutes of the fMRI session.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.

Countries

China

Contacts

Primary ContactTianzhen Chen, M.D, Ph.D
vomchan@hotmail.com021-34773523

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026