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

February 17, 2016 updated by: Guodong Gao, Tang-Du Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Department of neurosurgery, Tangdu Hospital
        • Sub-Investigator:
          • Xue-lian Wang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event related potentials(ERPs)
Time Frame: 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.
Day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local field potential(LFP)
Time Frame: 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.
in surgery,3 days after surgery
the 13-item obsessive compulsive drug use scale(OCDUS)
Time Frame: day 3
day 3
Opiate Addiction Severity Inventory(OASI)
Time Frame: day 3
day 3
participants' craving for opioid drugs (VAS)
Time Frame: day 3
The 10-point visual analog scale(VAS)will be utilized at day 3.
day 3
The Symptom Checklist-90(SCL-90)
Time Frame: day 3
The Symptom Checklist-90(SCL-90) is used to evaluate general status.
day 3
Self-Rating Depression Scale(SDS)
Time Frame: day 3
Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.
day 3
Yale-Brown Obsessive Compulsive Scale(Y-BOCS)
Time Frame: day 3
Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.
day 3
The Eysenck Personality Questionnaire(EPQ)
Time Frame: day 3
day 3
The Wechsler Memory Scale(WMS)
Time Frame: day 3
day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Investigators

  • Study Chair: Guo-dong Gao, M.D., Department of neurosurgery, Tangdu Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

October 14, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EEG/ERP and drug addiction

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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