An interventional study of Suzhou Sceneray® DBS System in Addiction, sponsored by Tang-Du Hospital. Status unknown at 5 sites in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-02-07.
Sponsored by Tang-Du Hospital · Not applicable, Interventional, and Treatment
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.
521 studies on the registry are indexed under Behavior, Addictive; 124 are open to participants now.
This study's planned enrollment of 60 is close to the median of 62 across 399 interventional studies indexed under Behavior, Addictive.
Browse Behavior, Addictive studies →Tang-Du Hospital is the lead sponsor of 167 studies on the registry; 78 are open to participants now.
Compared within Behavior, Addictive, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to )
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was turned on 1-2 weeks postoperatively.
Device: Suzhou Sceneray® DBS System
The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was off until 25 months postoperatively, during which the following up was kept, then the the stimulation was turned on 25 months postoperatively.
Device: Suzhou Sceneray® DBS System
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.
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
There 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
Start is estimated for Feb 2018; primary completion for Jan 2020, 23 months later.
Of 147 non-industry interventional studies with no phase under Behavior, Addictive, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's planned 23 months is below that.
Counting every sponsor, half of 155 studies reached it within 26 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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