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

Substance-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02594306
• Other study ID #: EEG/ERP and drug addiction
• Status: Recruiting
• Phase: N/A
• First received: October 14, 2015
• Last updated: February 17, 2016
• Start date: October 2015
• Est. completion date: November 2016

Study information

• Verified date: February 2016
• Source: Tang-Du Hospital
• Contact: Guo-dong Gao, M.D.
• Phone: +86 29 84777435
• Email: gguodong[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
China	Department of neurosurgery, Tangdu Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	local field potential(LFP)	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	No
Secondary	the 13-item obsessive compulsive drug use scale(OCDUS)		day 3	No
Secondary	Opiate Addiction Severity Inventory(OASI)		day 3	No
Secondary	participants' craving for opioid drugs (VAS)	The 10-point visual analog scale(VAS)will be utilized at day 3.	day 3	No
Secondary	The Symptom Checklist-90(SCL-90)	The Symptom Checklist-90(SCL-90) is used to evaluate general status.	day 3	No
Secondary	Self-Rating Depression Scale(SDS)	Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.	day 3	No
Secondary	Yale-Brown Obsessive Compulsive Scale(Y-BOCS)	Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.	day 3	No
Secondary	The Eysenck Personality Questionnaire(EPQ)		day 3	No
Secondary	The Wechsler Memory Scale(WMS)		day 3	No