Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347978
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-03-20
Brief Title:
Personalized DBS for OCD Guided by Stereoencephalography Mapping
Sponsor:
Andrew Moses Lee MD PhD
Organization:
University of California San Francisco
Study Overview
Official Title:
A Double-Blinded Randomized Crossover Trial of Stereoencephalography- Guided Four-Lead Personalized Deep Brain Stimulation for Treatment-Refractory Obsessive Compulsive Disorder SEEG-Guided DBS for OCD
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a double-blinded randomized crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD followed by open label stimulation for an additional 6 months The study will be conducted in 3 stages Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters Stage 2 will consist of 4-lead DBS surgery with bilateral IPGs and further optimization of stimulation parameters Stage 3 will be randomized crossover treatment followed by open label treatment
Detailed Description:
The study consists of 3 stages
In Stage 1 the investigators will implant SEEG depth electrodes into various components of the CSTC OCD circuit such as the OFC ACC VCVS BNST and amSTN The investigators will perform extensive stimulation mapping to identify anatomical sites and stimulation parameters that improve symptoms The investigators also intend to record abnormal local field potential LFP activity during periods of varying intensities of spontaneous and provoked OCD symptom severity and will determine if therapeutic stimulation can normalize abnormal neural activity associated with OCD symptoms
In Stage 2 the investigators will use the information obtained during the SEEG Invasive Monitoring phase Stage 1 to inform the placement of 4 DBS leads using the Medtronic Percept Implantable Pulse Generator system DBS leads will be targeted to regions identified in Stage 1 as being associated with symptomatic improvement and OCD-related neural activity During this phase the investigators will perform DBS programming to systematically change stimulation parameters to find parameters that optimally relieve patients OCD symptoms
In Stage 3 the investigators will then carry out a randomized controlled crossover trial to assess the safety feasibility and initial efficacy of our SEEG-guided DBS approach for treatment-refractory OCD
In Stage 1 the investigators will implant SEEG depth electrodes into various components of the CSTC OCD circuit such as the OFC ACC VCVS BNST and amSTN The investigators will perform extensive stimulation mapping to identify anatomical sites and stimulation parameters that improve symptoms The investigators also intend to record abnormal local field potential LFP activity during periods of varying intensities of spontaneous and provoked OCD symptom severity and will determine if therapeutic stimulation can normalize abnormal neural activity associated with OCD symptoms
In Stage 2 the investigators will use the information obtained during the SEEG Invasive Monitoring phase Stage 1 to inform the placement of 4 DBS leads using the Medtronic Percept Implantable Pulse Generator system DBS leads will be targeted to regions identified in Stage 1 as being associated with symptomatic improvement and OCD-related neural activity During this phase the investigators will perform DBS programming to systematically change stimulation parameters to find parameters that optimally relieve patients OCD symptoms
In Stage 3 the investigators will then carry out a randomized controlled crossover trial to assess the safety feasibility and initial efficacy of our SEEG-guided DBS approach for treatment-refractory OCD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None