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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-60
SponsorShanghai Mental Health Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • tTIS on dACC, theta frequency (5 Hz)

    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.

  • tTIS on dACC, High frequency

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Theta Stimulation(6Hz, generated with electrodes of 2kHz and 2.005kHz)Experimental treatment 1 intervention
Group B: High Frequency Stimulation(generated with two electrodes of 2kHz)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Activation of dACC

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

Time frame
Through the fMRI procedure
2

Activation of decision-making network

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

Time frame
Through the fMRI procedure
3

The change of impulsivity

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

Time frame
Through the last 20 minutes of the fMRI session.

Secondary outcomes

1

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.

Time frame
8 minutes, 16 minutes, 24 minutes, 44 minutes of the fMRI session.

Other outcomes

Sponsors and contacts

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