Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction

NCT ID: NCT03347474

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-20
• Study Completion Date: 2020-12-30

Brief Summary

The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus Accumbens(NAc) as a novel treatment in severe methamphetamine addiction. Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for methamphetamine.

Conditions

Treatment Methamphetamine Addiction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bilateral surgical implantation of DBS system to NAc

Group Type: EXPERIMENTAL

Bilateral surgical implantation of DBS system to NAc

Intervention Type: PROCEDURE

The Medtronic, PINS and SceneRay DBS device will be utilized in the present study.

Interventions

Bilateral surgical implantation of DBS system to NAc

The Medtronic, PINS and SceneRay DBS device will be utilized in the present study.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• DSM-IV-TR diagnosis of Drug addiction disorder;
• Age 18-65 years old;
• Proficiency in Mandarin language;
• Failure to detox more than three times;
• Capacity to provide informed consent (understanding of the study purpose and methods);

Exclusion Criteria

• Multidrug abuse and formation of addiction;
• Serious and unstable organic diseases (e.g. unstable coronal heart disease);
• Any history of seizure disorder or hemorrhagic stroke;
• Past stereotactic neurosurgical intervention;
• Neurological disease (Abnormal PET-CT, MRI, EEG)
• Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator;
• Contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases);
• HIV positive;
• Pregnancy and/or lactation;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bomin Sun

Director of the Department of Functional Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Ruijin Hospital Functional Neurosurgery

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chencheng Zhang, MD

Role: CONTACT

i@cczhang.org

+086-18217122884

Facility Contacts

Chencheng Zhang, MD

Role: primary

i@cczhang.org

+086-18217122884

Yingying Zhang, MSc

Role: backup

zhyy019@126.com

+086-17602137369

References

Kuhn J, Moller M, Treppmann JF, Bartsch C, Lenartz D, Gruendler TO, Maarouf M, Brosig A, Barnikol UB, Klosterkotter J, Sturm V. Deep brain stimulation of the nucleus accumbens and its usefulness in severe opioid addiction. Mol Psychiatry. 2014 Feb;19(2):145-6. doi: 10.1038/mp.2012.196. Epub 2013 Jan 22. No abstract available.

Reference Type: BACKGROUND

PMID: 23337942 (View on PubMed)

Other Identifiers

2018-10-25 DBS-NAc Meth

Identifier Type: -

Identifier Source: org_study_id