An interventional study of tTIS on dACC, theta frequency (5 Hz) and tTIS on dACC, High frequency in Gambling Disorder, sponsored by Shanghai Mental Health Center. Not yet recruiting at 1 site in China. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Basic science
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.
158 studies on the registry are indexed under Gambling; 42 are open to participants now.
This study's planned enrollment of 30 is below the median of 66 across 128 interventional studies indexed under Gambling.
Browse Gambling studies →Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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.
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.
Activation of dACC
Activation of dACC is measured with resting-state fMRI and task fMRI.
Time frame: 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.
Time frame: Through the fMRI procedure
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.
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.
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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