The Center for Neuromodulation at Mount Sinai is committed to research so that patients can benefit from new and innovative treatments. Research is enhanced by the quality of the academic environment at the Mount Sinai Health System.
Multi-Scale Investigation of the Living Human Brain
Multi-scale biology is a conceptual framework centered upon the idea that it is necessary to integrate many dimensions of data in order to understand the rules governing complex, dynamic physiological processes. Due to the inaccessibility of the human brain, however, rarely is it true that data from all of the components of the system in question can be measured in the same patient. This study circumvents this limitation by surveying a vast data landscape in patients undergoing the deep brain stimulation (DBS) implantation procedure. All diagnoses for which DBS is used as treatment at Icahn School of Medicine at Mount Sinai, be is standard of care or in the context of a clinical trial, are eligible for this study.
The primary study consists of obtaining biological samples from the brain, blood, and skin from each participant during the DBS procedure. In addition, participants who enroll in the main are given the option to participate in a secondary study, which consist of additional research procedures beyond the specimen collections. Specifically, participants who enroll in the secondary study will engage in a brief intraoperative cognitive task while neural recordings are performed.
As a whole, this study will generate an unprecedented amount of neurobiological information from each individual in living human cohort. In turn, this may yield new knowledge of human brain function and disease pathogenesis, as well as give rise to new diagnostic and treatment modalities.
The purpose of this study is to create a database with information on patients who have had DBS for the treatment of movement disorders, including Parkinson’s disease, dystonia, essential tremor, and Tourette syndrome. This database will allow us to better track patient outcomes and improve the quality of patient care by increasing our ability to predict these outcomes. Information for this database will be derived from medical records and will be used to help track patient outcomes for those who have had DBS.
Comparison of Quantitative Susceptibility and High-Resolution Tractography Magnetic Resonance Imaging Sequences with Micro Electrode Recording and Clinical Outcomes in DBS
The efficacy of DBS is largely dependent on accurate placement of the intracranial leads. As the quality of radiologic imaging improves, the standards for targeting need to be reevaluated to assure we are using the best available technology. The purpose of this study is to find out if a new imaging method can improve the accuracy of the placement of the DBS leads. We are attempting to compare image guided DBS with the gold-standard physiology/imaged based hybrid. We hope to develop an imaging protocol to supplant the need for microelectrode recording.
A Clinical Pilot Study Examining Bilateral Inhibition of the Lateral Habenula as a Target for Deep Brain Stimulation in Intractable Depression:
The purpose of this study was to look for new ways to treat major depressive disorder. Current treatments do not work for everyone with this disease. This study aimed to find out if electrical stimulation, through deep brain stimulation, of areas of the brain called the lateral habenula, could help control symptoms of treatment resistant depression. This study is closed and is no longer enrolling patients.
Clinical Trial for Major Depression Treatment
Traditional treatments for major depression include psychotherapy, medicine, repetitive transcranial magnetic stimulation, electroconvulsive therapy, and vagus nerve stimulation. A small portion of patients do not respond to any of these treatments. Deep brain stimulation is a last experimental option. It can be helpful in about half of people who did not benefit from the other approaches. This clinical trial explores the safety and efficacy of deep brain stimulation for treatment of major depression.
We can consider including you in this research trial for deep brain stimulation if you:
- Are age 25 to 70
- Can provide written informed consent
- Live within commuting distance of New York City and the study location (Mount Sinai West)
- Have a primary psychiatric diagnosis of major depressive disorder, either a single episode or recurrent type, without psychotic features, and are currently experiencing a major depressive episode, as diagnosed by a structured clinical interview. Two independent psychiatrists will confirm the diagnosis.
- Are currently experiencing an episode of at least two years’ duration or a history of more than three lifetime depressive episodes.
- Score at least 20 on the 17-item Hamilton Depression Rating Scale (HDRS-17)
- Have an average pre-operative HDRS-17 score of 20 or greater (averaged weekly evaluations during the four weeks prior to surgery) and an average pre-operative HDRS-17 score no more than 30 percent lower than the baseline screening HDRS-17 score.
- Are experiencing a maximum global assessment of functioning of 50 or less
- Are confirmed to have treatment-resistant depression. We define treatment resistance as:
- Failure to respond to a minimum of four different antidepressant treatments (including at least three medications from at least three different drug classes), evidence-based psychotherapy, or electroconvulsive therapy administered at adequate doses and duration during the current episode. We will require documentation (i.e., statement from the treating psychiatrist) that a treatment trial has failed (either no response to maximum tolerable doses for a minimum of four weeks, or side effects at sub-maximal doses) as coded by a revised Antidepressant Treatment History Form. The study investigators will confirm each treatment via review of records from referring psychiatrists and/or pharmacy records.
- Failure or intolerance of an adequate course of electroconvulsive therapy during any episode (confirmed by medical records) or not receiving this therapy for a reason considered valid by the study psychiatrist. Such reasons might include lack of availability of electroconvulsive therapy providers in the patient’s location, concern regarding the impact of cognitive side effects of the approach on current ability to work or function, or inability to obtain third-party payment for the therapy. We also recognize that a patient who has failed four medications in the current episode will achieve a lasting response with electroconvulsive therapy about 18 percent of the time (60 percent probability of an acute response and 30 percent of maintaining response for at least 24 weeks); patients who have refused this therapy because they feel the chance of benefit does not outweigh the risks associated with it will be considered eligible.
It is not safe for you to participate in the clinical trial if you have:
- Other Axis I conditions such as other mood, eating, psychotic, dissociative, or substance use disorders
- 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
- Other primary neurological disorders or unstable medical illness
- Conditions requiring anticoagulant therapy which cannot be discontinued for the perioperative period, as required
- Conditions requiring magnetic resonance imaging scans or diathermy
- Pregnancy or plans to become pregnant during the study period
- Contraindications for general anesthesia, neurosurgery, or a magnetic resonance imaging scan
- A cardiac pacemaker/defibrillator or other electrical device currently implanted that could interfere with deep brain stimulator or its functioning