Patient-specific, Effective, and Rational Functional Connectivity Targeting for DBS in OCD (PERFECT DBS)
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|ClinicalTrials.gov Identifier: NCT03244852|
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : March 7, 2019
|Condition or disease|
Recently, deep brain stimulation (DBS) has emerged as a potentially circuit-specific treatment for intractable OCD. DBS is programmable, allowing the clinician to "reshape" the volume of tissue activated within the standard ventral capsule/ventral striatum (VC/VS) target.
However, VC/VS DBS' efficacy is limited by two major factors: imperfect targeting and a lack of decision rules for stimulation adjustment. The VC/VS target is not a single identifiable structure, but encompasses white matter of the internal capsule and gray matter of the nucleus accumbens (NAc). In current practice for DBS in OCD, all patients are implanted at standard x,y,z coordinates in the VC/VS region. Due to this inter-subject anatomical variability, different fiber tracts are stimulated by ostensibly the "same" parameters in each subject, leading to variable outcomes. This investigation will identify aspects of VC/VS circuitry that may determine clinical response. The hypothesis is that good clinical outcomes may correlate to electrical field capture of either striatal gray matter or of white matter fibers connecting OFC to thalamus.
The current study looks to extend the neuroimaging investigation using anatomic white matter targeting, functional gray matter targeting and changes in changes in regional glucose metabolism of Deep Brain Stimulation (DBS) in severe obsessive-compulsive disorder (OCD) with the long-term aim of identifying biomarkers that could improve outcomes of this expensive and invasive therapy. Improved imaging would allow surgeons to place the DBS lead closer to the biological targets, thus improving efficacy of the treatment.
The objectives of this study are threefold:
- Improve the anatomic white matter targeting of the Deep Brain Stimulator (DBS) implant by tracing and identifying fibers of passage within the Ventral Capsule (VC) white matter using advance tractography methods in preoperative diffusion MRI data.
- Improve functional gray matter targeting by studying the overlap of the volume of tissue activated (VTA) with the VC voxels of maximal preoperative connectivity to the orbitofrontal cortex (OFC)
- Determine the changes in regional glucose metabolism using preoperative and post-treatment FDG-PET (Positron Emission Tomography) following 3 months of DBS treatment
|Study Type :||Observational|
|Estimated Enrollment :||11 participants|
|Official Title:||Patient-specific, Effective, and Rational Functional Connectivity Targeting for DBS in OCD|
|Actual Study Start Date :||September 15, 2017|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
OCD Patients with Deep Brain Stimulators
Patients with deep brain stimulation for intractable obsessive compulsive disorder (OCD)
- Yale-Brown Obsessive-Compulsive Scale (YBOCS) [ Time Frame: 6 months ]Yale-Brown Obsessive-Compulsive Scale (YBOCS) will be the principal outcome measure to correlate OCD symptoms severity.
- Yale-Brown Obsessive-Compulsive Scale (YBOCS) and Neural Correlates (1) [ Time Frame: 6 months ]Clinical improvement (change in YBOCS from baseline) will be correlated with the degree of postoperative capture of OFC fibers in the VTA of the active DBS contact
- Yale-Brown Obsessive-Compulsive Scale (YBOCS) and Neural Correlates (2) [ Time Frame: 6 months ]Clinical improvement (change in YBOCS from baseline) will be correlated with overlap of the volume of tissue activated (VTA) with the identified ventral striatum voxels of maximal preoperative connectivity to the OFC.
- Yale-Brown Obsessive-Compulsive Scale (YBOCS) and Neural Correlates (3) [ Time Frame: 6 months ]Clinical improvement (change in YBOCS from baseline) will be correlated with changes in regional glucose metabolism in the OFC, caudate, and thalamus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244852
|Contact: Darin D Dougherty, MD||724-6143 ext firstname.lastname@example.org|
|Contact: Alik S Widge, MD, PhD||643-2580 ext email@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Charlestown, Massachusetts, United States, 02129|
|Contact: Aishwarya K Gosai, BA 617-724-0244 firstname.lastname@example.org|
|Principal Investigator: Darin D Dougherty, MD|
|Principal Investigator:||Darin D Dougherty, MD||Massachusetts General Hospital|