Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification.According to the single-centered preliminary open-labeled prospective trial results, the investigators hypothesize that bilateral stimulation of the NAc will effectively reduce the relapse of the opiate dependence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations.
National Institute on Drug Dependence, Peking University
Beijing, Beijing Municipality, China
RECRUITINGNanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGDepartment of neurosurgery, Tangdu Hospital
Xi'an, Shaanxi, China
The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests）
If the participants or their families report no less than 2 times of the drug use in each of two consecutive weeks, or the consecutive 2 times of urine tests showed positive, or lost of follow-up, the case was defined as relapse
Time frame: At 25 weeks after DBS stimulation on
The total days of abstinence for participants
The total days of abstinence for participants
Time frame: Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
The longest duration for sustained abstinence for participants
The longest duration for sustained abstinence for participants
Time frame: Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Visual analog scale (VAS) craving score for opioid drugs
Ranging from 0-10,with 0 indicates no craving while 10 indicates extreme craving
Time frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Body weight for participants
Body weight for participants
Time frame: Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Hamilton Depression Scale（HAMD-17)
17 items,Total scores\<7: normal;7\<Total scores\<17:possible depression;17\<Total scores\<24:definite depression;Total score\>24: severe depression
Time frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Scaling for Opiate withdrawal symptoms
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Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGWest China Hospital
Chengdu, Sichuan, China
RECRUITINGThere were 19 items for rating 19 withdrawl symptoms, with 0 indicating none and 4 indicating most severe, the total scores are obtained by summary for scores of each items, ranging from 0-76, the higher the total scores indicating the worsen opiate withdrawl symptoms.
Time frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
The evaluation on MATRICS-test
Software system constructed by MATRICS company, which was used for evaluate the cognitive function of the participants
Time frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
The rate of positive urine test results
times of positive urine test/ total times of urine test
Time frame: Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Hamilton Anxiety Scale (HAMA)
14 items, Total scores\<6: normal;7\<Total scores\<14:possible anxiety;14\<Total scores\<21:definite anxiety;Total score\>21: severe anxiety
Time frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Pittsburgh sleep quality index(PSQI)
Scaling for evaluating the sleep quality, the higher total scores indicating the more difficulties on sleep, thus the higher total scores indicating the worsen sleep quality
Time frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Fagerstrom Test Nicotine Dependence assessment (FTND)
Scaling for Nicotine Dependence: The higher of scores indicating higher lever of Nicotine Dependence
Time frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Social Disability Screening Schedule (SDSS)
Scaling for Social Disability with 10 items, the higher total scores indicating the much severe social disability
Time frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Activity of Daily Living Scale (ADL)
Consists of Physical Self-maintenance Scale and Instrumental Activities of Daily Living Scale, ranging from 0-56, total scores \<14, normal; total score \>14, ADL dysfunction
Time frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
36-Item Short Form Health Survey (SF-36)
Scaling for Quality of life with 8 subscales, the higher total scores indicating the better quality of life.
Time frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on