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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theta Stimulation(6Hz, generated with electrodes of 2kHz and 2.005kHz) | Experimental | Session1#T1(10min)+DTI(15min) Session2#rsfMRI(8min)+rsfMRI-Theta tTIs(8min)+rsfMRI(8min)+TASK fMRI-Theta TI(20min) |
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| High Frequency Stimulation(generated with two electrodes of 2kHz) | Sham Comparator | Session1#T1(10min)+DTI(15min) Session2#rsfMRI(8min)+rsfMRI-HF tTIs(8min)+rsfMRI(8min)+TASK fMRI-HF TI(20min) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianzhen Chen, M.D, Ph.D | Contact | 021-34773523 | vomchan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Min Zhao, M.D, Ph.D | Shanghai Mental Health Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200000 | China |
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| 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. |
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| ID | Term |
|---|---|
| D005715 | Gambling |
| ID | Term |
|---|---|
| D012309 | Risk-Taking |
| D001519 | Behavior |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D001523 | Mental Disorders |
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