This is a double blind pilot feasibility study, with a within subject crossover design of DBS of the anterior cingulate bundle(ACB) and the ventral anterior limb of the internal capsule(vALIC) in four patients with intractable OCD. Patients will be screened according to inclusion exclusion criteria listed above, approved by an independent Neuropsychiatric review board and informed consent obtained.
OCD, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30 and a Global Assessment of Functioning (GAF) score of 45 or less.
Persistence of severe symptoms and impairment for five or more years despite at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (fluoxetine, sertraline, fluvoxamine, paroxetine, citalopram, escitalopram, or clomipramine) alone or in combination with ii. Adequate behavior therapy (≥20 sessions of expert exposure and response prevention), and iii. Augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.
Age between 21 and 65 years.
Able to understand and comply with instructions.
personal/family history (1st/2nd degree relatives) of schizophrenia or schizoaffective disorder, other primary psychotic disorder, bipolar disorder;
present PTS;
present acute suicidality or suicidal ideation;
personal history of head injury, epilepsy, tic or other neurological disorders, neurodevelopmental (e.g., autism), systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease from medical records and self-report (all of which may confound interpretation of neuroimaging measures);
Crossover
Medtronic Percept system and 3391 3387 Medtronic DBS electrodes
DeviceSurgical implantation of deep brain stimulation electrodes with stimulation at one of two intracranial targets depending on randomization and crossover status.
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).
Clinical Global Impression (CGI)
The CGI measures severity of illness and improvement in symptoms since enrollment. Items are each rated on a scale of 1-7. Higher scores indicate worse outcomes.
Global Assessment of Functioning (GAF)
The GAF measures overall functioning across multiple life domains. It is rated on a scale of 0-100. Higher scores indicate higher levels of functioning (i.e., better outcomes).
Global Assessment of Functioning (GAF)
The GAF measures overall functioning across multiple life domains. It is rated on a scale of 0-100. Higher scores indicate higher levels of functioning (i.e., better outcomes).
Global Assessment of Functioning (GAF)
The GAF measures overall functioning across multiple life domains. It is rated on a scale of 0-100. Higher scores indicate higher levels of functioning (i.e., better outcomes).
Sheehan Disability Scale (SDS)
The SDS measures social and occupational functional impairment resulting from psychiatric symptoms. It is rated on a scale of 0-30. Higher scores indicate greater functional impairment (i.e., worse outcomes).
Click on the lead sponsor to view all of their trials.
Rhode Island Hospital
Lead sponsor
Brown University
Collaborator
Baylor College of Medicine
Collaborator
Butler Hospital
Collaborator
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