Vanderbilt Clinical Neurosciences

Search a complete listing of all clinical trials underway at Vanderbilt here.

Memory Loss Trials

IRB # 120158: Memory & Aging Project
PI: Angela Jefferson, Ph.D., Director, Vanderbilt Memory & Alzheimer’s Center

The purpose of this research study is to examine relations between heart health and brain health among older adults. Participants must be 60 years or older. To see if you are eligible for the study, you will attend a 4 hour eligibility visit. During this visit, you will complete some paper and pencil tests of memory and thinking and answer questions about your medical history. If you are eligible, you will be asked to return for a study visit every 18 months for at least 5 years. The study visit takes place on two days. The first day lasts 5 hours. The second day lasts 2 hours. You will be asked to complete several tests, including blood work, memory testing, heart scans, and brain scans. There are some optional tests that you may complete, such as a special brain MRI and a lumbar puncture. These tests require you return on another day.

One of the benefits of this study is that we will complete a feedback session with you in person or by phone after you complete each study visit. During this feedback session, a study doctor will explain your memory test results and provide blood work and heart scan results. You will also be compensated for your time.

If you are interested, please contact the study’s Outreach and Recruitment Coordinator, Stephanie Mayers, by phone at (615) 875-3175 or by email at stephanie.mayers@vanderbilt.edu. All patients will complete a brief medical history screening by phone to ensure qualification.

Movement Disorders Trials

Stroke Trials

Secondary Prevention of Small Subcortical Strokes (SPS3): To define effective therapies for prevention of recurrent stroke and cognitive decline in patients with symptomatic small subcortical stroke or subcortical TIA. This study is looking at combined antiplatelet therapy and aggressive blood pressure lowering vs usual blood pressure management.
Trial Information
Consent Form

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P – TIMI 50): To study to effects of SCH 530348 when administered orally in addition to the standard of care for a minimum of 1 year in subjects with documented atherosclerotic disease in patients with recently diagnosed coronary artery disease as manifested by an MI, ischemic (presumed thrombotic) cerebrovascular disease, or peripheral arterial disease.

Siblings with Ischemic Stroke Study (SWISS): To perform a multi-center study of sibling pairs with stroke to systematically screen for regions of the human genome that contain genes which increase the risk of having an ischemic stroke.

MRI and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE): Successful conduct of the trial will evaluate whether use of MRI is a rational and appropriate selection criterion for mechanical recanalization therapy for acute ischemic stroke. A positive trial will suggest substantial clinical benefit from embolectomy therapy in the group of patients with a penumbral MRI pattern, and permit informed design of definitive phase 3 trial(s) of endovascular embolectomy.
Trial Information
Consent Form

Inhibition of Lipid Peroxidation and Cerebral Vasospasm by an Acetaminophen-Based Regimen in Patients with Aneurysmal Subarachnoid Hemorrhage-this is a single-center, double-blinded NIH funded clinical trial that we are conducting with Dr. John Oates in Clinical Pharmacology.

SENTIS-Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke-this is a prospective, controlled, randomized, single-blind, multi-center study comparing NeuroFlo treatment plus standard medical management versus standard medical management alone in ischemic stroke less than 14 hours from symptom onset. The sponsor is CoAxia, Inc.

Neurosurgery Trials

IRB #060155: Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy
PI: Peter Konrad, MD, Ph.D., Director of Functional Neurosurgery, Vanderbilt Neurosurgery
The purpose of this IRB approved study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years or older. Thus, this proposal request authorization by the IRB to allow patients at VUMC to access this HUD therapy.

IRB #050477: Implantable Systems Performance Registry
PI: Peter Konrad, MD, Ph.D., Director of Functional Neurosurgery, Vanderbilt Neurosurgery
Medtronic Neurological developed the Implantable System Performance Registry (ISPR) to monitor the survivability of commercially available Medtronic implantable drug infusion and neurostimulation systems on an ongoing basis. Data obtained and analyzed from this registry is used by both the PI (Konrad) and Medtronic to assess product performance in the clinical setting and guide future product development efforts aimed at improving neurological product reliability. The objectives of the ISPR are to evaluate and quantify implantable system device-related event-free survival based on categorization of ISPR events and to collect data on potential explanatory variables that may be used to analyze the cause or identify the contributing factors for device failure. The specific devices that will be tracked relate to implanted infusion pumps for delivery of drugs to the nervous system, and implanted stimulation devices for electrical stimulation of the nervous system.

IRB #050822: Optical Stimulation in Peripheral Nerves from Selective Rhizotomy Cases
PI: Peter Konrad, MD, Ph.D., Director of Functional Neurosurgery, Vanderbilt Neurosurgery
Whether studying single cells or modifying nerve cell function in humans during clinical procedures, the traditional method of neuronal stimulation is based on use of transient electrical pulses. However, electrical stimulation of neural tissue is constrained by a) physical laws such that electrical fields produce artifacts (noise) in the vicinity of the stimulating electrode, and b) physical contact of the stimulating electrode with the tissue. Furthermore, most extracellular electrodes stimulate not only neurons immediately adjacent to the electrode but also many other neurons surrounding the region that diminishes exponentially from the center of stimulation. To selectively stimulate a discrete, small population of axons within a nerve bundle, the electrode must be typically very close to the neuron or impale the neuron (intracellular electrode). Electrical stimulation methodology therefore lacks the spatial specificity needed to target individual sensory or motor fibers in the central and peripheral nervous systems without physically invading the immediate region surrounding the neuron. In summary, the limitations of electrical stimulation include high frequency artifacts associated with the stimulation signal that limit data analysis and prevent simultaneous stimulation and recording of adjacent areas, tissue-electrode interface issues that are significant for either acute or chronic stimulation, a population response due to the recruitment of multiple axons, and in general, poor spatial specificity.

Recent work in our laboratories has shown feasibility of a fundamentally different approach to neural stimulation by using pulsed optical rather than electrical energy to induce nerve potentials. This approach presents a new paradigm to in vivo neural activation based on low levels of pulsed infrared light. We have already demonstrated the feasibility and safety of this technique in the stimulation of sciatic nerves in invertebrates (frogs) and vertebrates (rats). Optical stimulation at physiologically useful and optimal laser parameters provides a contact-free, spatially selective, artifact-free method for stimulation that is harmless to nerve tissue. Optical stimulation theoretically has significant advantages over electrical methods for a variety of diagnostic and therapeutic clinical applications, such as peripheral nerve mapping during surgery and possibly the development of an implant with the specificity needed for a peripheral neural prosthesis. This study is designed to test the safety of optical peripheral nerve stimulation in human subjects using the optimal laser parameters determined from our animal model studies.

The purpose of this proposal is to determine the safe and effective levels of optical stimulation (in Joules / cm2) in peripheral nerves of humans undergoing nerve resection surgery. We have identified patients that undergo elective peripheral nerve sectioning or resection: children undergoing nerve sectioning (selective rhizotomy) for treatment of medically refractory spasticity associated with cerebral palsy.

IRB #060232: Physiological Brain Atlas Development
PI: Peter Konrad, MD, Ph.D., Director of Functional Neurosurgery, Vanderbilt Neurosurgery
Deep brain stimulator (DBS) implants are used in the treatment of medically refractory movement disorders (such as Parkinson’s disease and tremor) and are being explored for other uses in modulating focal disorders in small regions of the brain. The surgery to implant a DBS unit however is still very time consuming and uncomfortable to most patients due to the uniqueness of each individual brain and the need to map out each patients response to stimulation on an individual basis. Although anatomical atlases exist to guide the implant, in the end the success of the implant and its subsequent use depends on a very detailed knowledge of the microanatomy surrounding the intended target of therapy with DBS. To date, collection of the physiological data is individualized for every patient, and statistical analysis of populations of the unique physiology specific to the micro-environment surrounding a DBS implant was not possible due to the differences in anatomy among patients.

At Vanderbilt, new methodology allowing comparisons of identical micro-anatomical regions of the brain through sophisticated computer techniques has allowed for the first time, the ability to collate physiological data within a normalized MRI-based atlas. This research study proposes to use the clinical, physiological, and anatomical data that is normally collected before, during and after the DBS is implanted and used. , The data will be deposited in a statistically meaningful fashion associated with a normalized (non-patient specific or generic) MRI scan. The correlation of these data with micro-anatomical precision will allow physicians involved in DBS implants to: 1) Select better and more precise targets within the brain to achieve the desired physiological effect, 2) reduce the amount of unnecessary “groping” for the ideal target location during surgery, and 3) improve the post-implant programming and management of the DBS unit.
Vanderbilt Neurosurgery is the coordinating center for this multi-center study.

IRB #110632: The Impact of Deep brain Stimulation on Frontal-Subcortical Emotional Processin
PI: Joseph Neimat, MD, MS
The major goals of this project are to analyze responses from single neurons and neuronal ensembles in the basal ganglia of patients undergoing DBS surgery during presentation of emotional behavior stimuli, and to observe changes in frontal activity and consequent changes in emotional behavior caused by high-frequency electrical stimulation in nuclei of the basal ganglia.

IRB #091003: Humanitarian Device Exemption for Medtronic Reclaim OCE Therapy
PI: Joseph Neimat, MD, MS
The purpose of this study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of obsessive compulsive disorder (OCD). The FDA has recently issued a humanitarian device exemption (HDE) for the use of the deep brain stimulator device in the treatment of OCD in the treatment of chronic, intractable (drug refractory) OCD. The FDA does, however, require that centers performing the procedure obtain IRB approval within their institution. Thus, this proposal requests authorization by the IRB to allow patients at VUMC to access this HDE therapy.
In addition, because this surgery represents novel therapy in an area of considerable public health impact and scientific interest we are requesting IRB approval to gather clinical pre- and post-operative data to evaluate the efficacy of this therapy and to report its effect on measures of cognitive and emotional performance.

IRB #071210: Behavioral Correlates of DBS Stimulation
PI: Joseph Neimat, MD, MS
This proposal is designed to identify the behavioral effects of deep brain stimulation (DBS) when patients DBS stimulators are turned on, when they are turned off, or when they are set to suboptimal stimulation parameters. These experiments are divided into two aims designed to identify the affective and cognitive consequence of DBS stimulation. Behavioral measures will be correlated with functional changes identified by hemodynamic signals in the cerebral cortex, or the underlying structures.

IRB #070666: Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
PI: Joseph Neimat, MD, MS
Deep brain stimulator (DBS) implants are used in the treatment of medically refractory movement disorders such as Parkinson’s disease, essential tremor and dystonia. Because of the uniqueness of each individual brain, the surgery to implant a DBS electrode requires detailed anatomic and physiological information for each patient. The anatomic data is obtained before surgery via a Magnetic Resonance Imaging (MRI) scan of the patient’s brain. Physiological data is obtained during the operation via micro-electrode recording of the patient’s brain and neurological examination of the patient. Therefore, DBS surgery can be uncomfortable to patients, as it can be very time consuming and requires the patient to be awake and attentive.

The majority of patients tolerate this DBS implantation with the use of local anesthetic medications at the site of incision. However, sometimes patients do not tolerate the procedure secondary to anxiety and discomfort. Dexmedetomidine Hydrochloride injection (Precedex™) is a medication with the unique properties of cooperative sedation, anxiolysis, and analgesia, without the respiratory depression commonly seen with other sedatives. This medication is commonly used during awake neurosurgical tumor and seizure operations 1,4. In addition, Dexmedetomidine (DEX) has been used at Vanderbilt and other institutions during DBS implantation 3. Although large neurosurgery centers including Vanderbilt Neurosurgery have used DEX during DBS surgery, no study has investigated the effects of clinically appropriate dosages of DEX on micro-electrode recording of the patient’s brain and the patient’s neurological exam.

IRB #060998: Neural Correlates of Cognition and Affect on DBS Patients
PI: Joseph Neimat, MD, MS
The basal ganglia have long been known to play an important role in movement. This has made them important targets for the neurosurgical treatment of movement disorders such as Parkinson’s disease and dystonia. Deep brain stimulation (DBS) has largely replaced former ablative surgeries in the treatment of these disorders, as DBS can be adjusted or discontinued as necessary.

Although DBS has proven highly effective for the treatment of movement disorders, such stimulation occasionally produces profound effects on emotion, thought and behavior. The proposed mechanism for these side effects is coincidental stimulation of affective and cognitive circuits that are thought to run in parallel to the motor circuits through the basal ganglia. This theory is based primarily on data from animal studies, however, and it remains unclear how the cognitive and affective circuits are organized in the human basal ganglia.

The surgical procedure for implantation of DBS electrodes in patients requires extensive electrophysiological recording from the neurons of the basal ganglia. This procedure allows us to identify the borders of the target nuclei so that the permanent DBS electrodes can be placed with precision. This recording process represents an important opportunity to examine the response of neurons to cognitive and affective stimuli. In this protocol we propose to study the properties of these neurons so that we can map out the cognitive and affective regions of the nuclei targeted for different DBS procedures. Moreover, we intend to substantiate the theories that have been described on parallel cognitive/emotional circuits, and to expand understanding on physiological properties of these circuits.

IRB #061281: the Sensitivity of Intrinsic Signal Imaging in Human Cortex
PI: Michael Remple, PhD.
The purpose of this study is to test the sensitivity of a technique, called intrinsic signal imaging (ISI), for the intraoperative identification of human functional and dysfunctional cortex. We propose that the ability to optically monitor neuronal activity in a large area of cortex in "real-time" will be a more sensitive and timesaving method of brain mapping than the electrical methods currently available. The applications of this technique will not only theoretically increase the safety and efficacy of many of neurosurgical procedures, but will be useful as an investigational tool to study human cortical physiology.

Pediatric Epilepsy Trials

Brivaracetam
Vanderbilt is participating in a clinical trial to evaluate brivaracetam (BRV) oral solution as adjunctive therapy in children (ages 1 month to 16 years) with epilepsy. The safety and pharmacokinetic data from this study will be used for BRV dose adaptation in pediatric subjects with epilepsy. Brivaracetam is chemically similar to Keppra, an antiepileptic medication (AED) already approved. Studies in healthy volunteers and adult patients have shown that brivaracetam is well tolerated. The results of this study will be used for deciding the best dosages of the study drug for treating children with epilepsy.

Perampanel
Vanderbilt is participating in a clinical trial to determine if perampanel, can help young people with epilepsy. In this research study, we are studying the overall safety, effectiveness and tolerability of the study drug in young people aged 12 to less than 18 years. The study will also try and find out if the study drug has any effect on cognition (that is, the ability to know, learn, perceive, recognize, remember, think and understand), and on growth and sexual development. The study also looks at how much of the study drug and other antiepileptic drugs (AEDs) are in children’s blood over a period of time.

Lacosamide
The purpose of this research study is to evaluate the safety of Lacosamide (LCM) and how the body processes LCM syrup, which will be taken by mouth twice a day, about 12 hours apart. This study is for children between the ages of 1 month and 17 years with a diagnosis of epilepsy with partial-onset seizures who have not achieved control of their seizures after taking at least two antiepileptic medication (AEDs) at the same time or one followed by another. Patients can currently be taking one to three AEDs. The information collected in this study will help select the target dose range (the amount of drug to be given based on the patient’s body weight) to use with children who have partial-onset seizures.

Clinical research projects in pediatric epilepsy are headed by Eric Piña-Garza, M.D.
For questions regarding descriptions of the studies call Selena McCoy Carpenter at (615) 875-4897 or email selena.m.carpenter@vanderbilt.edu.