Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation
Study Details
Study Description
Brief Summary
Drug addiction is compulsive and spontaneous drug-taking behavior which is characterized by non-medical usage, long and repeated exposure to addictive drugs and gradually increasing drug-taking dosage and frequency,and become a main threat against human being's public health, economic development and social safety.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Effective treatments for severe drug addiction are limited. China centers employing compulsory detoxification, reported a 3 year abstinence rate of only 15%. For the methadone maintenance therapy, relapse often occurs promptly after cessation of methadone. A Malaysian reports about taking naltrexone or buprenorphine treating,showed average relapsed time of 2 or 3 months,respectively.
Assessment for psychological craving degree of addiction patients is also a difficult thing.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Non operation Recording the event related potential of drug addicts when they receive the stimulus of Emotional pictures stimulation system. |
Device: Emotional pictures stimulation system
Emotional pictures stimulation system is component of neutral and drug-related images.
|
| Experimental: Deep brain stimulation Recording the event related potential after the deep brain stimulation operation.Recording the local field potential of drug addiction people when we conduct a test of adjacent contact stimulation in the deep brain stimulation operation. Recording the waveform of bilateral NAc/ALIC after puting the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule |
Device: Emotional pictures stimulation system
Emotional pictures stimulation system is component of neutral and drug-related images.
Procedure: Deep brain stimulation
Deep brain stimulation of bilateral NAc/ALIC
Procedure: adjacent contact stimulation
The electrode of deep brain stimulation has four contacts.We stimulate one contact,and record the local field potential of other contacts.
Procedure: microelectrode
We put the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule,to record the waveform of bilateral NAc/ALIC.
|
| Active Comparator: Standard Control Recording the event related potential of normal people when they receive the stimulus of emotional pictures stimulation system. |
Device: Emotional pictures stimulation system
Emotional pictures stimulation system is component of neutral and drug-related images.
|
Outcome Measures
Primary Outcome Measures
- Event related potentials(ERPs) [Day 3]
Event related potentials include late positive potential（LPP),P300,mismatch negativity(MMN) and N400.Recording the event related potential when people receive the stimulus of emotional pictures stimulation system.
Secondary Outcome Measures
- local field potential(LFP) [in surgery,3 days after surgery]
Recording the LFP of DBS group without any stimulation and stimulate one contact in surgery and 3 days after surgery.
- the 13-item obsessive compulsive drug use scale(OCDUS) [day 3]
- Opiate Addiction Severity Inventory(OASI) [day 3]
- participants' craving for opioid drugs (VAS) [day 3]
The 10-point visual analog scale(VAS)will be utilized at day 3.
- The Symptom Checklist-90(SCL-90) [day 3]
The Symptom Checklist-90(SCL-90) is used to evaluate general status.
- Self-Rating Depression Scale(SDS) [day 3]
Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.
- Yale-Brown Obsessive Compulsive Scale(Y-BOCS) [day 3]
Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.
- The Eysenck Personality Questionnaire(EPQ) [day 3]
- The Wechsler Memory Scale(WMS) [day 3]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age between 18 and 65 years of age, male or female；
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Opiate addictive over 3 years；
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Physical detoxification completed（keep abstinent for at least 7 days，acute abstinent syndrome disappeared，morphine urinalysis and naloxone test showed negative)；
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No obvious neuropsychiatry and personality disorders；
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No severe infectious disease；
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Good compliance and be able to complete follow up；
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General health is good，no severe liver、kidney、heart and lung disease；
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Informed consent issued
Exclusion Criteria:
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Severe cognitive disorders（MMSE scale: illiteracy≤17，primary school≤20，secondary school or above≤24）,bad compliance because of dementia,unable to issue the informed content；
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History of severe neuropsychiatric disease；
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Epilepsy；
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severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension；
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Malignant tumor；History of brain trauma；Pregnant female；
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Patients are taking part in other clinical trials in recent 3 months；
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Being deem as unfit for the trials by researcher.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of neurosurgery, Tangdu Hospital | Xi'an | Shaanxi | China | 710038 |
Sponsors and Collaborators
- Tang-Du Hospital
Investigators
- Study Chair: Guo-dong Gao, M.D., Department of neurosurgery, Tangdu Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EEG/ERP and drug addiction