Gambling DisorderNCT06467422
Effects of Transcranial Temporal Interference Stimulation on Risky Decision-making and Impulse Control in Gambling Disorder
A study testing tTIS on dACC, theta frequency (5 Hz) and tTIS on dACC, High frequency in people with Gambling Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Gambling Disorder
- What is being tested?
- tTIS on dACC, theta frequency (5 Hz) and tTIS on dACC, High frequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200000
Min Zhao, M.D, Ph.D, 18017311005
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Gambling Disorder
- Being tested
- tTIS on dACC, theta frequency (5 Hz), tTIS on dACC, High frequency
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 frequencyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: tTIS on dACC, theta frequency (5 Hz) |
| 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) Receives: Device: tTIS on dACC, High frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation of dACC
Activation of dACC is measured with resting-state fMRI and task fMRI.
Measured: 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.
Measured: Through the fMRI procedure
The change of impulsivity
The change of impulsivity will be measured by sequential decision-making task.
Measured: 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.
Measured: 8 minutes, 16 minutes, 24 minutes, 44 minutes of the fMRI session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Zhao, M.D, Ph.D, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467422
- Sponsor's protocol ID
- MZhao-017
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06467422
- Acronym / sponsor ID
- MZhao-017
- Conditions
- Gambling Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theta Stimulation(6Hz, generated with electrodes of 2kHz and 2.005kHz) | Experimental | Device: tTIS on dACC, theta frequency (5 Hz)Session1#T1(10min)+DTI(15min) Session2#rsfMRI(8min)+rsfMRI-Theta tTIs(8min)+rsfMRI(8min)+TASK fMRI-Theta TI(20min) |
| High Frequency Stimulation(generated with two electrodes of 2kHz) | Sham comparator | Device: tTIS on dACC, High frequencySession1#T1(10min)+DTI(15min) Session2#rsfMRI(8min)+rsfMRI-HF tTIs(8min)+rsfMRI(8min)+TASK fMRI-HF TI(20min) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tTIS 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. | Device | Theta Stimulation(6Hz, generated with electrodes of 2kHz and 2.005kHz) |
| tTIS on dACC, High frequencyThe 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. | Device | High Frequency Stimulation(generated with two electrodes of 2kHz) |
Primary outcome
Activation of dACC
Time frame: Through the fMRI procedure
Activation of dACC is measured with resting-state fMRI and task fMRI.
Activation of decision-making network
Time frame: Through the fMRI procedure
Activation of decision-making network is measured with resting-state fMRI and task fMRI connectivity analysis.
The change of impulsivity
Time frame: Through the last 20 minutes of the fMRI session.
The change of impulsivity will be measured by sequential decision-making task.
1 secondary outcome
The change of gambling craving
Time frame: 8 minutes, 16 minutes, 24 minutes, 44 minutes of the fMRI session.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Zhao, M.D, Ph.D study chair
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tTIS on dACC, theta frequency (5 Hz) and tTIS on dACC, High frequency in people with Gambling Disorder, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianzhen Chen, M.D, Ph.D (021-34773523, vomchan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activation of dACC (time frame: Through the fMRI procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.