Alcohol addiction
Conditions
Interventions
tTIS Intervention Group:Bilateral locus coeruleus tTIS stimulation, with stimulation parameters as follows: current intensity is 15 mA, stimulation frequency is 50 Hz. The stimulation is continuous fo
Control Group:Apply a stimulation with a current intensity of 15 mA and a frequency of 50 Hz only at the start and end of the stimulation, for approximately 60 seconds, which includes a 30 - second ra
tTIS Intervention Group:Bilateral nucleus accumbens tTIS stimulation, with the following stimulation parameters: the current intensity is 2 mA, the stimulation frequency is 130 Hz. The stimulation is
Control Group:Apply a 2 mA, 130 Hz stimulation only at the start and end of each session. The stimulation lasts approximately 60 seconds, including a 30 - second ramp - up and ramp - down phase. The o
Sponsors
Health Commission of Hunan Province
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Clinical Trial: Efficacy and Safety of tTIS in Intervention in Brainstem Erulean Nucleus in AWS Patients and Inclusion Criteria for Brain Mechanism Study 1. All cases meet DSM-V diagnostic criteria for alcohol withdrawal syndrome; 2. Education level is junior high school or above; 3. Adult patients or above, aged 18~65 years old; 4. All subjects had normal visual acuity or corrected visual acuity and normal color vision; 5. Clinical Institutional Alcohol Withdrawal Assessment Scale (CIWA-Ar) score >=7 points; 6. Cooperate with follow-up and observation, and have good compliance; 7. Voluntarily participate in the study and study and sign the informed consent form. Clinical Trial: Inclusion Criteria for the Study of the Efficacy and Safety of tTIS in the Intervention of Alcohol Addiction Relapse with Brain Mechanisms 1. All cases meet the diagnostic criteria for alcohol addiction in the DSM-V; 2. Education level is junior high school or above; 3. Adult patients or above, aged 18~65 years old; 4. All subjects had normal visual acuity or corrected visual acuity and normal color vision; 5. Completion of acute withdrawal treatment >=5 days, Clinical Institution Alcohol Withdrawal Assessment Scale (CIWA-Ar) score < 7 points; 6. Cooperate with follow-up and observation, and have good compliance; 7. Voluntarily participate in the study and study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Clinical Trial: Efficacy of tTIS intervention in the nucleus coeruleus of the brainstem in AWS patients, and exclusion criteria for safety and brain mechanism studies 1. Risk of neurological diseases or seizures, such as previous craniocerebral diseases, head trauma, EEG abnormalities, magnetic resonance evidence of brain structural abnormalities, or family history of epilepsy; 2. Those who are dependent on other substances other than nicotine dependence before enrollment; 3. Those who have or have mental disorders such as schizophrenia, severe depression, and manic episodes; 4. Have a history of serious physical illness or a history of disease that may affect the central nervous system; 5. Contraindications to magnetic resonance scanning or tTIS, such as the presence of metallic or electronic devices in the body (intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies); 6. Have received or are receiving electroconvulsive therapy, modified electroconvulsive therapy, transcranial magnetic stimulation, transcranial direct current stimulation, transcranial alternating current stimulation or other neurostimulation treatments; 7. Pregnant and lactating women; 8. Those who are unable to express their feelings; 9. Those who are participating in other clinical trials. Clinical Trial: Efficacy and Safety of tTIS in Intervention for Alcohol Addiction Relapse and Exclusion Criteria for Brain Mechanism Studies 1. Risk of neurological diseases or seizures, such as previous craniocerebral diseases, head trauma, EEG abnormalities, magnetic resonance evidence of brain structural abnormalities, or family history of epilepsy; 2. Those who are dependent on other substances other than nicotine dependence before enrollment; 3. Those who have or have mental disorders such as schizophrenia, severe depression, and manic episodes; 4. Have a history of serious physical illness or a history of disease that may affect the central nervous system; 5. Contraindications to magnetic resonance scanning or tTIS, such as the presence of metal or electronic devices (intracranial metallic foreign bodies, cochlear implants, pacemakers and stents and other metallic foreign bodies) in the body; 6. Have received or are receiving electroconvulsive therapy, modified electroconvulsive therapy, transcranial magnetic stimulation, transcranial direct current stimulation, transcranial alternating current stimulation or other neurostimulation treatments; 7. Pregnant and lactating women; 8. Those who are unable to express their feelings; 9. Those who are participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain imaging evaluation;Proportion of heavy drinking days at 4, 12, and 24 weeks after randomization/intervention;Cardiac output;Withdrawal Symptom Assessment;The Total Dose of Benzodiazepines Used;Craving Situation Score;Anxiety Status Score;Depression Situation Score ;Sleep Condition Scoring;The occurrence of adverse events;Proportion of days with heavy drinking;Proportion of days without alcohol consumption;Proportion of the longest consecutive days without alcohol consumption;Impulsivity Score;Cognitive Status Assessment;Assessment of Hedonic State; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of alcohol-free days at 4, 12, and 24 weeks after randomization/intervention;Proportion of longest consecutive alcohol-free days during 4, 12, and 24 weeks of observation after randomization/intervention;Daily/weekly alcohol consumption (total daily/weekly alcohol consumption) at 4, 12, and 24 weeks post-intervention;Alcohol craving scores during randomized/post-intervention observation;Assessment of impulsivity during randomized/post-intervention observation;Cognitive and pleasure assessment during randomized/post-intervention observation; | — |
Countries
China
Contacts
Public ContactZhou Xuhui
The Second People’s Hospital of Hunan Province (Brain Hospital of Hunan Province)
Outcome results
None listed