Deep Brain Stimulation of the Bilateral Nucleus Accumbens for Patients With Methadone Maintenance Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2021-06-01

Brief Summary

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Methadone maintenance treatment (MMT) is one of the main forms of treatments for opioid dependence. Despite its effectiveness and widespread use, people will experience withdrawal if daily dose is insufficient or missed, promoting reluctance to attempt detoxification. In addition, methadone is a full opioid agonist which can induce respiratory depression or sedation without ceiling level, so overdose usage can be fatal. Hence, an alternative therapy is needed to completely reduce the carving for drugs and to relieve the negative affective sate caused by withdrawal.

Deep brain stimulation (DBS) is a reasonable treatment approach for addiction. Since 2009 the first case report emerged, the nucleus accumbens (NAc) is still the only brain target to be investigated in clinical case series of DBS for alcohol and heroin addiction.

This research will mainly investigate the effectiveness and safety of NAc-DBS for patients with methadone maintenance treatment. The investigators will also explore the influence of NAc-DBS on brain activity and cognition.

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Detailed Description

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Conditions

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Addiction Opiate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DBS

All subjects will undergo bilateral surgical implantation of DBS system in the Nucleus Accumbens. The DBS system will be active at two days after surgery.

Group Type EXPERIMENTAL

Bilateral surgical implantation of DBS system to Nucleus Accumbens

Intervention Type PROCEDURE

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 contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip).

Interventions

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Bilateral surgical implantation of DBS system to Nucleus Accumbens

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 contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* MINI diagnosis of substance dependence;
* Proficiency in Mandarin language;
* Failure to detox more than three times;
* Long-term methadone maintenance treatment;
* Capacity to provide informed consent (understanding of the study purpose and methods);

Exclusion Criteria

* Schizophrenia(MINI diagnosis);
* Antisocial personality disorder(MINI diagnosis);
* Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator;
* Severe cognitive impairments(MoCA ≤ 22);
* Enrollment in other clinical trials;
* Stereotactic respectively neurosurgical intervention in the past;
* Contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases);
* Serious or instable organic diseases (e.g. instable coronal heart disease);
* Tested positively for HIV;
* Pregnancy and/or lactation;
* Epilepsy or other severe brain trauma or neurological impairments;

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No