- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05160129
Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To improve DBS for severe OCD, the anatomical specificity with which stimulation is delivered must be enhanced. In this study, patients will receive personalized and circuit specific stimulation to five target ALIC pathways based on pre-surgery brain scan analysis where patient-specific blueprints are created and used to determine implant location. Stimulation to the ALIC is delivered by directional segmented electrodes which are designed to deliver precise activation of circuits of interest and minimize excess tissue activation that can cause side effects. In this study, ALIC DBS will target white matter pathways, each having different cortical projections that affect different behavioral outputs, instead of traditional targeting. Each of these chosen pathways have been shown to be involved in the effects of ALIC DBS for OCD, but the results vary between studies.
The current study involves routine implantation of bilateral DBS leads into the ALIC brain region, which are connected to an internal pulse generator (IPG) device that is implanted under the skin near the collar bone and controls stimulation delivery. Before surgery, patients will receive a high definition 7T MRI brain scan to carefully plan the personalized lead implantation. Following surgery, patients will receive routine clinical visits for optimizing the DBS parameters and monitoring of clinical effects. As part of this study, patients will participate in EEG recordings at stimulation initiation and after 6 and 12 months. In addition, patients will complete behavioral paradigm testing bimonthly during stimulation of circuit-specific DBS contacts.
The goal of this study is to create a blueprint map of the brain that characterizes pathways that are found in effective treatment of OCD. This will be done by determining which pathways are activated by stimulation in different locations in ALIC and linking these locations with changes in task performance. This will allow for specification of the ideal anatomical target for DBS for OCD for maximum therapeutic benefit.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sonia Olson
- Phone Number: 238279 212-523-4000
- Email: sonia.olson@mssm.edu
Study Contact Backup
- Name: Martijn Figee
- Email: martijn.figee@mssm.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10019
- Recruiting
- Mount Sinai West
-
Contact:
- Martijn Figee
- Phone Number: 212-523-8962
- Email: martijn.figee@mssm.edu
-
Principal Investigator:
- Martijn Figee
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
All participants will receive ALIC DBS for OCD. DBS received a Humanitarian Device Exemption (HDE) in 2009 with an indication for bilateral stimulation of the ALIC as an adjunctive treatment to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-refractory OCD in adult patients who have failed at least three SSRIs. Additionally, more stringent criteria have been selected for defining treatment-resistance in this protocol, as indicated below.
INCLUSION CRITERIA:
- 18 years of age or older
- Primary psychiatric diagnosis of Obsessive-Compulsive Disorder (OCD, per DSM-5 criteria)
- Meets FDA Humanitarian Device Exemption (HDE) criteria for indication
- Has elected to receive clinically indicated DBS for OCD with a directional system outside of this research study, as determined by treating clinician(s) and per current clinical practice
- Minimum of a five-year history of treatment-refractory OCD with substantial functional impairment
- Failure of an adequate trial of at least three of the following SSRIs: Fluoxetine, Fluvoxamine, Citalopram, Escitalopram, Sertraline, Paroxetine
- Failure of an adequate trial of clomipramine
- Failure of an adequate trial of one or more of the aforementioned antidepressants in combination with at least one of the following augmentation agents: Haloperidol, Risperidone, Olanzapine, Quetiapine, Ziprasidone, Aripiprazole
- Failure of an adequate trial of Cognitive Behavioral Therapy (CBT), defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist
- Minimum score of 25 on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at preoperative baseline
- Ability to undergo preoperative MRI
- English proficiency
- Capacity to provide written informed consent
- Willing and able to comply with all device operation and study-related procedures
EXCLUSION CRITERIA:
- Ineligible or unwilling to receive ALIC DBS for OCD
- Contraindications for general anesthesia, neurosurgery, or an MRI scan
- Neurological disorder or other significant brain pathology, such as moderate / marked cerebral atrophy, stroke, tumor, epilepsy, or previous neurosurgical procedures (excluding cingulotomy, which may be permitted if not contraindicated in the opinion of implanting neurosurgeon)
- Unstable medical illness, chronic immunosuppression, and/or considerably reduced life-expectancy
- Conditions requiring anticoagulant therapy which cannot be discontinued for the perioperative period, as required
- Conditions requiring certain regular MRI scans or diathermy
- Currently implanted with a cardiac pacemaker / defibrillator or other implanted electrical device which may interfere with DBS stimulator or the function of which may be impacted by its implantation, in the opinion of evaluating neurosurgeon
- Other primary Axis I disorder or history of psychosis, such as schizophrenia, psychosis in the context of depressive or manic episode.
- Current or past history within the 6 months prior to DBS implantation of substance abuse or dependence (excluding nicotine and caffeine)
- Active suicidal ideation with intent, suicide attempt within the last six months, more than three suicide attempts within the last two years, or serious suicide risk as determined by the study psychiatrists
- Axis II disorders which, in the opinion of the study psychiatrist, may increases the risk of DBS to participants or cause study non-compliance
- Patients who lack the capacity to for proper device usage and maintenance, in the opinion of the research team
- Women who are pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Circuit-selective DBS
People suffering from severe obsessive-compulsive disorder (OCD)
|
DBS will be applied selectively to different electrode contacts/ segments to evaluate clinical, behavioral, and electrocortical responses of specific pathways within the ALIC.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame: Pre-surgical baseline, monthly up to 12 months postoperative
|
This scale measures change in OCD symptom severity.
Full scale from from 0 - 40 with higher score indicating more severe symptoms.
|
Pre-surgical baseline, monthly up to 12 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investment Task
Time Frame: Pre-surgical baseline, bimonthly up to 12 months postoperative
|
This computational investment task provides a measure of reward valuation by measuring decision making related to different reward conditions. Computational computer tasks: These behavioral tasks provide a measure of reward valuation, cognitive flexibility under conditions of uncertainty, and a measure of inhibitory control. |
Pre-surgical baseline, bimonthly up to 12 months postoperative
|
Reversal Task
Time Frame: Pre-surgical baseline, bimonthly up to 12 months postoperative
|
This computational reversal task provides a measure of cognitive flexibility under conditions of uncertainty. Computational computer tasks: These behavioral tasks provide a measure of reward valuation, cognitive flexibility under conditions of uncertainty, and a measure of inhibitory control. |
Pre-surgical baseline, bimonthly up to 12 months postoperative
|
Stop Signal Task
Time Frame: Pre-surgical baseline, bimonthly up to 12 months postoperative
|
This computational stop signal task provides a measure of inhibitory control by assessing stop-signal reaction time. Computational computer tasks: These behavioral tasks provide a measure of reward valuation, cognitive flexibility under conditions of uncertainty, and a measure of inhibitory control. |
Pre-surgical baseline, bimonthly up to 12 months postoperative
|
Tractography pathway activation models (Diffusion-weighted-imaging)
Time Frame: Baseline: Pre-surgery
|
Data collected from MRI scans will be used to measure structural connectivity in the brain (i.e., white matter pathways) that is used for surgical planning.
|
Baseline: Pre-surgery
|
Deep brain stimulation evoked potentials (EEG)
Time Frame: postoperative months 0, 6, 12
|
Evoked potentials provide a measure of electrophysiological, effective connectivity in the brain.
Alpha, beta, theta, gamma and delta bandwidths will be assessed.
|
postoperative months 0, 6, 12
|
Change in Beck Depression Inventory (BDI)
Time Frame: Pre-surgical baseline, monthly up to 12 months postoperative
|
This scale indicates the presence and severity of depressive symptoms.
Full scale from 0 to 63 , with higher score indicating more severe depression.
|
Pre-surgical baseline, monthly up to 12 months postoperative
|
Change in Beck Anxiety Inventory (BAI)
Time Frame: Pre-surgical baseline, monthly up to 12 months postoperative
|
This scale measures severity of anxiety symptoms.
Full scale from 0 to 63, with higher score indicating more severe anxiety.
|
Pre-surgical baseline, monthly up to 12 months postoperative
|
Change in Barratt Impulsiveness Scale (BIS-11)
Time Frame: Pre-surgical baseline, monthly up to 12 months postoperative
|
This is a clinical measure of impulsivity.
Full scale from 30 -120, with a higher score indicating greater impulsivity.
|
Pre-surgical baseline, monthly up to 12 months postoperative
|
Change in Young Mania Rating Scale (YMRS)
Time Frame: Pre-surgical baseline, monthly up to 12 months postoperative
|
This scale measures the presence and severity of mania.
Full scale from 0 - 60, with higher scores indicating more severe mania.
|
Pre-surgical baseline, monthly up to 12 months postoperative
|
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Pre-surgical baseline, monthly up to 12 months postoperative
|
This scale measures risk of suicide on multiple dimensions, scored by answering "yes or no" questions where answers of "yes" may indicate risk.
Full range from 0 to 9, with higher score indicating higher intensity suicidal ideation.
|
Pre-surgical baseline, monthly up to 12 months postoperative
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Martijn Figee, Icahn School of Medicine and Mount Sinai
- Principal Investigator: Ki Sueng Choi, Icahn School of Medicine and Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY-21-00125
- 1R01MH123542-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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