The purpose of this study is to determine if personalized (adaptive) Deep Brain Stimulation (DBS) based upon invasive brain mapping is safe and can lead to better outcomes like reductions in craving and opioid use.
This study will enroll individuals with severe Opioid Use Disorder (OUD) who have not responded to standard treatments. The devices used in this study are investigational, which means they are not approved by the Food and Drug Administration (FDA) to treat OUD. The information we obtain in this study will be used to better understand the mechanisms of OUD in the brain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
6
An individualized aDBS protocol will be used to examine therapeutic effect.
University of California, San Francisco
San Francisco, California, United States
RECRUITINGIncidence of adverse events during sEEG phase
To assess the safety of sEEG mapping in patients with severe and refractory OUD.
Time frame: Up to 2 weeks during sEEG phase.
Incidence of adverse events during aDBS phase
To assess the safety of aDBS in patients with severe and refractory OUD.
Time frame: Up to 16 months from time of DBS implantation.
sEEG Mapping: Brain mapping
To identify individualized brain targets for sensing neural biomarkers of craving and stimulation to mitigate craving.
Time frame: Up to 2 weeks during sEEG phase.
Opioid use duirng aDBS treatment
To evaluate the preliminary efficacy of individualized aDBS in patients with severe and refractory OUD by measuring the effects of aDBS on opioid use measured with TLFB.
Time frame: Up to 16 months from time of DBS implantation.
Overall functioning duirng aDBS treatment
To evaluate the preliminary efficacy of individualized aDBS in patients with severe and refractory OUD by measuring the effects of aDBS on quality of life measured with SF-36.
Time frame: Up to 16 months from time of DBS implantation.
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