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Trial record 11 of 12 for:    dbs | addiction

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

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ClinicalTrials.gov Identifier: NCT02594306
Recruitment Status : Unknown
Verified February 2016 by Guodong Gao, Tang-Du Hospital.
Recruitment status was:  Recruiting
First Posted : November 3, 2015
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):
Guodong Gao, Tang-Du Hospital

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.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Device: Emotional pictures stimulation system Procedure: Deep brain stimulation Procedure: adjacent contact stimulation Procedure: microelectrode Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation
Study Start Date : October 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. the 13-item obsessive compulsive drug use scale(OCDUS) [ Time Frame: day 3 ]
  3. Opiate Addiction Severity Inventory(OASI) [ Time Frame: day 3 ]
  4. participants' craving for opioid drugs (VAS) [ Time Frame: day 3 ]
    The 10-point visual analog scale(VAS)will be utilized at day 3.

  5. The Symptom Checklist-90(SCL-90) [ Time Frame: day 3 ]
    The Symptom Checklist-90(SCL-90) is used to evaluate general status.

  6. Self-Rating Depression Scale(SDS) [ Time Frame: day 3 ]
    Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.

  7. 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.

  8. The Eysenck Personality Questionnaire(EPQ) [ Time Frame: day 3 ]
  9. The Wechsler Memory Scale(WMS) [ Time Frame: day 3 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594306


Contacts
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Contact: Guo-dong Gao, M.D. +86 29 84777435 gguodong@fmmu.edu.cn
Contact: Xue-lian Wang, M.D. +86 29 84777284 wxlian@fmmu.edu.cn

Locations
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China, Shaanxi
Department of neurosurgery, Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710038
Contact: Guo-dong Gao, M.D.    +86 29 84777435    gguodong@fmmu.edu.cn   
Sub-Investigator: Xue-lian Wang, M.D.         
Sponsors and Collaborators
Tang-Du Hospital
Investigators
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Study Chair: Guo-dong Gao, M.D. Department of neurosurgery, Tangdu Hospital

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Responsible Party: Guodong Gao, Neurosurgery Department, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02594306     History of Changes
Other Study ID Numbers: EEG/ERP and drug addiction
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Guodong Gao, Tang-Du Hospital:
drug addiction
Heroin
craving
event related potential
crystal methamphetamine

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders