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

NCT06467422 | Not Yet Recruiting

• 1 other identifier: MZhao-017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gambling Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (1)

• The change of gambling craving

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

Study Arms (2)

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)

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)

Device: tTIS on dACC, High frequency

Interventions

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.

Theta Stimulation(6Hz, generated with electrodes of 2kHz and 2.005kHz)

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.

High Frequency Stimulation(generated with two electrodes of 2kHz)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Study Officials

• Min Zhao, M.D, Ph.D

  Shanghai Mental Health Center

  STUDY CHAIR

Central Study Contacts

Tianzhen Chen, M.D, Ph.D

CONTACT

021-34773523; vomchan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 21, 2024
• Study Start: June 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 1, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CN (1)