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

Primary Purpose

Substance-Related Disorders

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Emotional pictures stimulation system
Deep brain stimulation
adjacent contact stimulation
microelectrode
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring drug addiction, Heroin, craving, event related potential, crystal methamphetamine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Department of neurosurgery, Tangdu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Non operation

Deep brain stimulation

Standard Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Event related potentials(ERPs)
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)
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)
Opiate Addiction Severity Inventory(OASI)
participants' craving for opioid drugs (VAS)
The 10-point visual analog scale(VAS)will be utilized at day 3.
The Symptom Checklist-90(SCL-90)
The Symptom Checklist-90(SCL-90) is used to evaluate general status.
Self-Rating Depression Scale(SDS)
Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.
Yale-Brown Obsessive Compulsive Scale(Y-BOCS)
Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.
The Eysenck Personality Questionnaire(EPQ)
The Wechsler Memory Scale(WMS)

Full Information

First Posted
October 14, 2015
Last Updated
February 17, 2016
Sponsor
Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02594306
Brief Title
Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation
Official Title
Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tang-Du Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
Keywords
drug addiction, Heroin, craving, event related potential, crystal methamphetamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non operation
Arm Type
Experimental
Arm Description
Recording the event related potential of drug addicts when they receive the stimulus of Emotional pictures stimulation system.
Arm Title
Deep brain stimulation
Arm Type
Experimental
Arm 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
Arm Title
Standard Control
Arm Type
Active Comparator
Arm Description
Recording the event related potential of normal people when they receive the stimulus of emotional pictures stimulation system.
Intervention Type
Device
Intervention Name(s)
Emotional pictures stimulation system
Intervention Description
Emotional pictures stimulation system is component of neutral and drug-related images.
Intervention Type
Procedure
Intervention Name(s)
Deep brain stimulation
Intervention Description
Deep brain stimulation of bilateral NAc/ALIC
Intervention Type
Procedure
Intervention Name(s)
adjacent contact stimulation
Intervention Description
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
Intervention Name(s)
microelectrode
Intervention Description
We put the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule,to record the waveform of bilateral NAc/ALIC.
Primary Outcome Measure Information:
Title
Event related potentials(ERPs)
Description
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.
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
local field potential(LFP)
Description
Recording the LFP of DBS group without any stimulation and stimulate one contact in surgery and 3 days after surgery.
Time Frame
in surgery,3 days after surgery
Title
the 13-item obsessive compulsive drug use scale(OCDUS)
Time Frame
day 3
Title
Opiate Addiction Severity Inventory(OASI)
Time Frame
day 3
Title
participants' craving for opioid drugs (VAS)
Description
The 10-point visual analog scale(VAS)will be utilized at day 3.
Time Frame
day 3
Title
The Symptom Checklist-90(SCL-90)
Description
The Symptom Checklist-90(SCL-90) is used to evaluate general status.
Time Frame
day 3
Title
Self-Rating Depression Scale(SDS)
Description
Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.
Time Frame
day 3
Title
Yale-Brown Obsessive Compulsive Scale(Y-BOCS)
Description
Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.
Time Frame
day 3
Title
The Eysenck Personality Questionnaire(EPQ)
Time Frame
day 3
Title
The Wechsler Memory Scale(WMS)
Time Frame
day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18 and 65 years of age, male or female； Opiate addictive over 3 years； Physical detoxification completed（keep abstinent for at least 7 days，acute abstinent syndrome disappeared，morphine urinalysis and naloxone test showed negative)； No obvious neuropsychiatry and personality disorders； No severe infectious disease； Good compliance and be able to complete follow up； General health is good，no severe liver、kidney、heart and lung disease； Informed consent issued Exclusion Criteria: 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； History of severe neuropsychiatric disease； Epilepsy； severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension； Malignant tumor；History of brain trauma；Pregnant female； Patients are taking part in other clinical trials in recent 3 months； Being deem as unfit for the trials by researcher.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo-dong Gao, M.D.
Phone
+86 29 84777435
Email
gguodong@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xue-lian Wang, M.D.
Phone
+86 29 84777284
Email
wxlian@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo-dong Gao, M.D.
Organizational Affiliation
Department of neurosurgery, Tangdu Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of neurosurgery, Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo-dong Gao, M.D.
Phone
+86 29 84777435
Email
gguodong@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xue-lian Wang, M.D.

12. IPD Sharing Statement

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

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