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

NCT ID: NCT02594306

Last Updated: 2016-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Substance-Related Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Non operation

Recording the event related potential of drug addicts when they receive the stimulus of Emotional pictures stimulation system.

Group Type EXPERIMENTAL

Emotional pictures stimulation system

Intervention Type DEVICE

Emotional pictures stimulation system is component of neutral and drug-related images.

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

Group Type EXPERIMENTAL

Emotional pictures stimulation system

Intervention Type DEVICE

Emotional pictures stimulation system is component of neutral and drug-related images.

Deep brain stimulation

Intervention Type PROCEDURE

Deep brain stimulation of bilateral NAc/ALIC

adjacent contact stimulation

Intervention Type PROCEDURE

The electrode of deep brain stimulation has four contacts.We stimulate one contact,and record the local field potential of other contacts.

microelectrode

Intervention Type PROCEDURE

We put the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule,to record the waveform of bilateral NAc/ALIC.

Standard Control

Recording the event related potential of normal people when they receive the stimulus of emotional pictures stimulation system.

Group Type ACTIVE_COMPARATOR

Emotional pictures stimulation system

Intervention Type DEVICE

Emotional pictures stimulation system is component of neutral and drug-related images.

Interventions

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Emotional pictures stimulation system

Emotional pictures stimulation system is component of neutral and drug-related images.

Intervention Type DEVICE

Deep brain stimulation

Deep brain stimulation of bilateral NAc/ALIC

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guodong Gao

Neurosurgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guo-dong Gao, M.D.

Role: STUDY_CHAIR

Department of neurosurgery, Tangdu Hospital

Locations

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Department of neurosurgery, Tangdu Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guo-dong Gao, M.D.

Role: CONTACT

+86 29 84777435

Xue-lian Wang, M.D.

Role: CONTACT

+86 29 84777284

Facility Contacts

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Guo-dong Gao, M.D.

Role: primary

+86 29 84777435

Other Identifiers

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EEG/ERP and drug addiction

Identifier Type: -

Identifier Source: org_study_id

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