Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder

The primary goal of this research study is to conduct a small scale randomized, double-blind clinical cross-over trial of deep brain stimulation for obsessive-compulsive disorder targeting the anteromedial subthalamic nucleus (amSTN), with which study team will not only produce high quality data of the clinical efficacy of DBS for OCD, but also attain critical insights into the neurophysiological underpinnings of disease and symptoms in OCD. This work will support future innovative therapy development, including refinement of surgical targeting and optimization of therapeutic stimulation. This will be a 3-year study with the aim of implanting 10 patients with bilateral amSTN DBS leads. Intra-operatively, precise single neuron recordings will be obtained at the therapeutic target while the patient participates symptom provocation. Participants will be implanted with a sensing pulse generator (Medtronic Percept) which enables chronic recordings from the amSTN target in addition to providing therapeutic stimulation. Each participant will be randomized to start with either a sham control stimulation phase or therapeutic stimulation, and cross-over at 4 months. If symptoms recur upon cross-over from therapeutic to sham stimulation, participants will exit the sham stimulation phase and rescue therapy/stimulation will be delivered. All participants will transition to an open label stimulation phase for chronic therapy. Multiple assessments of the participants will follow, including OCD severity, cognition, behavior, and side effects. Formal psychiatric assessments will take place at two weeks, at one month, and then once every three weeks during the randomization blinded period and then every 6 weeks during the open label period. During psychiatric assessments, the PERCEPT device will be used to obtain neural recordings of the STN activity. Additionally, for the secondary outcome measure for the association between amSTN activity and cognitive/emotional measure there are two components of this measure that are of a qualitative nature. Burstiness and coherence are unitless measures and thus will not be included in the outcome measure reporting section. They will instead be discussed in the limitation section at annual reporting.