Genomic Studies of OCD
The goal the project will be to identify multiple Obsessive-Compulsive Disorder (OCD) risk genes, each carrying large effects that will provide essential molecular clues to the origins of OCD and offer avenues for the development of new treatments.
This is a multi-center study with Rutgers University, University of Iowa, University of Miami, Mass General Hospital, McLean Hospital, Yale University, and Rogers Behavioral Health. We will be recruiting patients with OCD for this study and potentially their biological parents for this genetics study. This study will involve filling out questionaires regarding psychiatric/medical history, OCD symptoms, and information regarding related conditions such as tic disorder, trichotillomania, and attention deficit hyperactivity disorder (ADHD). Subsequently, a more in depth psychological evaluation may also take place. A blood draw will then be performed for this genetics study.
Please email [email protected] if you are interested in participating or have any questions about the study.
Personalized DBS for OCD Guided by Stereoencephalography Mapping
ClinicalTrials.gov Identifier: NCT06347978
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.
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.
The purpose of this study is to determine if personalized deep brain stimulation (DBS) based upon invasive brain mapping is safe and can lead to better outcomes.
The information we obtain in this study will be used to better understand the parts of the brain involved in Obsessive Compulsive Disorder (OCD).
We are looking for a total of 10 adult patients with treatment-refractory OCD. This study will be conducted in three stages, including implantation of SEEG depth electrodes for brain mapping, placement of the DBS system, and a randomized, shamcontrolled crossover trial, followed by open label treatment.
Please email [email protected] if you are interested in participating or have any questions about the study.
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Improving Treatment Outcomes for Adolescents with OCD by adding Transcranial Magnetic Stimulation (TMS)
(Teen OCD TMS study)
ClinicalTrials.gov Identifier: Pending
As many as 50% of children and adolescents with Obsessive Compulsive Disorder (OCD) experience continuing significant and impairing symptoms even after receiving medication and cognitive-behavioral therapy.
The goal of this pilot study is to explore if adding Transcranial Magnetic Stimulation (TMS) to ongoing treatments can lead to further improvement and even remission of OCD in teens who have experienced limited or no response to usual treatment with medication and/or cognitive-behavioral therapy (CBT).
TMS is FDA-approved for treatment resistant OCD in adults, and is safe in children and teens, but TMS has not been carefully studied in adolescent OCD.
If eligible, all adolescents in the study will receive a 3-week intensive TMS treatment under close monitoring as well as a MRI of the brain before and after TMS.
This project’s goal is to determine whether treatment with TMS administered to one of two assigned stimulation sites proves to be acceptable and shows some evidence of benefits in adolescents with OCD. The study is led by Drs. James McCracken and A Moses Lee.
Transcranial Magnetic Stimulation to Treat Compulsivity in Anorexia Nervosa
ClinicalTrials.gov Identifier: NCT06138782
Repetitive transcranial magnetic stimulation (rTMS) is being studied as a treatment for Anorexia Nervosa (AN). It involves non-invasive electromagnetic brain stimulation at the orbitofrontal cortex. TMS is also regularly used to treat other neuropsychiatric disorders such as depression and obsessive-compulsive disorder (OCD). Both AN and OCD are characterized by the propensity toward cognitive inflexibility. Since TMS is an effective FDA-cleared treatment for OCD, the researchers believe that it may also be an effective treatment for AN.
There are two groups for this study that each have a separate purpose. The purpose of the first group (ages 14 – 45) is to evaluate long-term changes in the brain specific to habit-directed networks in participants with anorexia nervosa (AN). Participants in this group will undergo functional magnetic resonance imaging (fMRI) at least 5 times over a 10-month period. Participants in this first group will not receive rTMS treatment.
The purpose of the second group (ages 18 - 45) is to determine if rTMS is effective in treating AN. Participants in this group will receive rTMS treatment for 10 days (2 consecutive weeks). Each day will involve 5 rTMS treatments over the course of 5 hours. Participants in this group will also undergo fMRI before the first TMS treatment and after the final TMS treatment.
We are currently recruiting for both groups.
Please send us an email at [email protected] if you are interested in participating or have any questions.
Cortical Stimulation to Treat OCD
ClinicalTrials.gov Identifier: NCT04958096
Deep brain stimulation (DBS) is a treatment for severe, refractory OCD that is not responsive to medical and cognitive therapies. It involves the implantation of electrodes into the brain for the purpose of delivering electrical stimulation to disrupt abnormal activity that causes OCD. DBS is also regularly used to treat other neuropsychiatric disorders such as Parkinson's disease, other movement disorders, and epilepsy. While DBS is effective for many patients, approximately 30% of patients do not respond at the existing DBS subcortical target, which is in the ventral capsule/ventral striatum (VC/VS) region.
The purpose of this study is to investigate novel cortical targets for brain stimulation to treat OCD and to identify abnormal brain signals associated with OCD and psychiatric symptoms. While treating OCD with standard deep brain stimulation (DBS) therapy, additional electrodes will be implanted in the anterior cingulate and prefrontal cortex, regions known be involved with OCD, for the purposes of identify OCD-related signals and to determine whether stimulation delivered to these parts of the brain in addition to the subcortical VC/VS can improve OCD symptoms.
We are currently recruiting adults 22 and older with severe OCD (YBOCS>=28) to participate. To be eligible, patients must have trialed:
- at least 2 SSRIs at adequate doses
- augmentation with an antipsychotic
- Clomipramine
- at least 6 months of exposure response prevention therapy or have undergone an intensive therapy program
Please email [email protected] if you are interested in participating or have any questions about the study.
Mapping the Network Impact of DBS using fMRI
Deep brain stimulation (DBS) is a targeted circuit-based treatment that has been used to treat severe cases of OCD.11 DBS involves electrical stimulation delivered through electrodes implanted in deep structures in the brain to modulate neural circuits. DBS is targeted to the anterior limb of the internal capsule (ALIC), which receives connections from the OFC and ACC.11,12 Advances in DBS technology now allow for MR imaging to be performed while DBS is On/Off. With these advances in technology, we can now comprehensively anatomically map the impact of DBS across the brain using fMRI. These objective biomarkers of OCD, therapeutic response, and related psychiatric symptoms can in turn be used to develop more efficient, data-driven approaches to identifying optimal DBS settings that improve outcomes and minimize adverse side effects.
For our stimulation-based functional MRI (sb-fMRI) study, we plan to enroll patients who have previously or will be implanted with the FDA HDE-approved Medtronic Percept DBS system for treatment refractory OCD.
Please email [email protected] if you are interested in participating or have any questions about the study.