Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 14, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFebruary 19, 2016
February 1, 2016
1.1 years
October 14, 2015
February 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 3
Secondary Outcomes (9)
local field potential(LFP)
in surgery,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 Symptom Checklist-90(SCL-90)
day 3
- +4 more secondary outcomes
Study Arms (3)
Non operation
EXPERIMENTALRecording the event related potential of drug addicts when they receive the stimulus of Emotional pictures stimulation system.
Deep brain stimulation
EXPERIMENTALRecording 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
Standard Control
ACTIVE COMPARATORRecording the event related potential of normal people when they receive the stimulus of emotional pictures stimulation system.
Interventions
Emotional pictures stimulation system is component of neutral and drug-related images.
The electrode of deep brain stimulation has four contacts.We stimulate one contact,and record the local field potential of other contacts.
We put the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule,to record the waveform of bilateral NAc/ALIC.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tang-Du Hospitallead
Study Sites (1)
Department of neurosurgery, Tangdu Hospital
Xi'an, Shaanxi, 710038, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guo-dong Gao, M.D.
Department of neurosurgery, Tangdu Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neurosurgery Department
Study Record Dates
First Submitted
October 14, 2015
First Posted
November 3, 2015
Study Start
October 1, 2015
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
February 19, 2016
Record last verified: 2016-02