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Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation

T

Tang-Du Hospital

Status

Unknown

Conditions

Substance-Related Disorders

Treatments

Procedure: adjacent contact stimulation
Device: Emotional pictures stimulation system
Procedure: Deep brain stimulation
Procedure: microelectrode

Study type

Interventional

Funder types

Other

Identifiers

NCT02594306
EEG/ERP and drug addiction

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Age between 18 and 65 years of age, male or female;
  2. Opiate addictive over 3 years;
  3. Physical detoxification completed(keep abstinent for at least 7 days,acute abstinent syndrome disappeared,morphine urinalysis and naloxone test showed negative);
  4. No obvious neuropsychiatry and personality disorders;
  5. No severe infectious disease;
  6. Good compliance and be able to complete follow up;
  7. General health is good,no severe liver、kidney、heart and lung disease;
  8. Informed consent issued

Exclusion criteria

  1. 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;
  2. History of severe neuropsychiatric disease;
  3. Epilepsy;
  4. severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension;
  5. Malignant tumor;History of brain trauma;Pregnant female;
  6. Patients are taking part in other clinical trials in recent 3 months;
  7. Being deem as unfit for the trials by researcher.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 3 patient groups

Non operation
Experimental group
Description:
Recording the event related potential of drug addicts when they receive the stimulus of Emotional pictures stimulation system.
Treatment:
Device: Emotional pictures stimulation system
Deep brain stimulation
Experimental group
Description:
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
Treatment:
Procedure: Deep brain stimulation
Procedure: adjacent contact stimulation
Device: Emotional pictures stimulation system
Procedure: microelectrode
Standard Control
Active Comparator group
Description:
Recording the event related potential of normal people when they receive the stimulus of emotional pictures stimulation system.
Treatment:
Device: Emotional pictures stimulation system

Trial contacts and locations

1

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Central trial contact

Xue-lian Wang, M.D.; Guo-dong Gao, M.D.

Data sourced from clinicaltrials.gov

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