PI: Willie
Short study title: Enhancing Memory in Humans: the Role of the Amygdala
Short description: We know from anecdotal experiences that emotional states are important in the formation of memories. Previous studies in animals and humans have shown that direct electrical stimulation of a specialized area of the amygdala can improve a type of memory called declarative memory. The purpose of this study is to understand the neural networks and mechanisms behind this and other types of neuromodulation techniques. Procedures involved in this study include stimulation of implanted electrodes for mapping connectivity and the use of memory and recognition tasks to assess neural circuit function. We are specifically interested in the interplay between the amygdala and the medial temporal lobe in the formation of memory as it relates to specific emotional states. This study aims to help us better understand normal and abnormal memory pathways and to leverage this knowledge to treat psychiatric and other neurological disorders. Patients are only eligible to participate if they are scheduled to undergo surgery with intracranial depth electrodes to determine location of seizure onset.
Key eligibility criteria:
- Any sex, age 18 through 75
- Must be able to understand and speak English
- Diagnosis of refractory epilepsy scheduled to undergo long-term intracranial video monitoring for seizure onset localization
- Must be implanted with intracranial depth electrodes to the left or right amygdala, hippocampus, and para-hippocampal/perirhinal cortices
Contact person: Brigette Vaughn, 314-273-0368, b.vaughn@wustl.edu
Enrollment period: March 2021 – Current
PI: Willie
Protocol ID: NCT02844465
Short study title: Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE)
Short description: Stereotactic laser ablation is a minimally-invasive alternative to open surgery for temporal lobe epilepsy. The surgery works by delivering laser heat energy through an implanted probe that heats tissue. All temperature changes are monitored in real-time by an MRI machine connected to a computer workstation. The purpose of this study is to evaluate the safety and efficacy of the Visualase® Laser Ablation System, an FDA cleared and commercially released device.
Key eligibility criteria:
- Any sex, age 18 through 70
- Diagnosis of medically refractory epilepsy, defined as failure of adequate trials of two tolerated and appropriately chosen and used antiepileptic drug (AED) schedules
- Diagnosis of mesial temporal lobe sclerosis, based on MRI obtained within 24 months of enrollment
- If the subject has a vagal nerve stimulator (VNS), the subject must have failed to achieve sustained seizure freedom with the device for at least 6 months prior to enrollment
- On a stable AED (or stable VNS setting) for 30 days prior to procedure and compliant with medication use
- Must have an average of at least 12 qualifying seizures in the 12 months prior to enrollment
- Must speak English or Spanish
- Excludes: patients with implanted devices with contraindication to MRI (e.g., deep brain stimulation or response neurostimulator), previous intracranial surgery for treatment of epilepsy, patients with epileptogenic extra-temporal lesions, noncompliant to medications, IQ < 70, dementia, unstable major psychiatric illness, allergy to gadolinium, pregnancy
Contact person: Brigette Vaughn, 314-273-0368, b.vaughn@wustl.edu
Enrollment period: December 2016 – May 2022
For more information: https://clinicaltrials.gov/ct2/show/NCT02844465
PI: Willie
Short study title: Intracalvarial Prefrontal Cortical Stimulation for Severe Treatment-Resistant Depression
Short description: Treatment-resistant depression presents a significant challenge given the limited options available and side effects of medications, but developing new and effective therapies is not trivial. This investigation proposes investigating a method to directly modulate the dorsolateral prefrontal cortex in order to modify neural circuits involved in depression. The device is a minimally-invasive device implanted into the skull bone overlying the left dorsolateral prefrontal cortex (region near the left forehead, behind the hairline) that will provide neurostimulation. The electrode will be tunneled under the skin to an implanted battery implanted in the left chest, below the collarbone. After surgery, there will be a 4-week period where medications and stimulation parameters are held constant. After this, changes in stimulation parameters and concomitant antidepressant drugs will be permitted for non-responders. Subjects will be asked to complete evaluations for depression and neurocognitive/memory testing at regular intervals up to 1 year after surgery.
Key eligibility criteria:
- Any sex, age 21 through 80
- Diagnosis of Major Depressive Disorder (according to DSM V) who have met criteria for the study (≥ 2 failed therapy attempts)
- Must have a history of at least one prior response to transcranial magnetic stimulation
- Subjects must undergo a specialized MRI before surgery which will assist in surgical planning
- Excludes: patients unable to hold constant psychotropic medications for 1 month prior to and 4 months after surgery
Contact person: Brigette Vaughn, 314-273-0368, b.vaughn@wustl.edu
Enrollment period: March 2021 – Current
PI: Leuthardt
Protocol ID: 202109069
Short study title: The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Motoneuron Excitability
Short description: Stimulation of the vagus nerve is currently FDA-approved for treating intractable epilepsy and chronic depression, and it is under investigation for various other applications, such as in stroke, tinnitus, and cognitive impairments. Transcutaneous auricular vagal nerve stimulation (taVNS) is a noninvasive nerve stimulation administered to the outer ear which contains a branch of the vagus nerve, and may have widespread effects on neural biology in the brain and spinal cord. taVNS may involve electrical and/or vibrotactile stimulation. The goal of this study is to understand the effect of a commercially-available taVNS device on the excitability of neurons within the spinal cord of healthy adult volunteers with the hopes of eventually applying this technology to aid in rehabilitation in patients suffering from chronic stroke. Various stimulation parameters of the taVNS will be tested and a specific evoked muscle response in the hand, a quantitative measurement of spinal motor neuron excitability, will be measured to determine the effects of these stimulation parameters.
Key eligibility criteria:
- Any sex, age 18 through 55
- Only one visit is required
Contact person: Kara Donovan, kara.donovan@wustl.edu
Enrollment period: September 2021 – Current
PI: Willie
Protocol ID: 202011033
Short study title: Investigation of Neural Circuitry during Awake Deep Brain Stimulator Placement
Short description: Deep brain stimulators are implanted devices that target regions of the brain such as the basal ganglia and the thalamus that can modulate abnormal circuits and treat patients with movement disorders such as Parkinson’s disease, dystonia, and essential tremor. However, the nuances of the brain responses to deep brain stimulation and the behavioral changes are not known and remain to be investigated. During some surgeries, patients are kept awake under local anesthesia, which allows for immediate feedback for symptom control and confirmation of electrode placement. The aim of this project is to record and analyze brain electrical activity during placement of electrodes during awake surgery, which already takes place as part of the standard surgical approach. Patients may also be asked to perform additional motor and behavioral tasks for research purposes. We may also use alternative stimulation parameters and perform recordings using a temporarily placed strip electrode through the same incision and burr hole used for electrode placement. We hope that new information learned from these investigations can uncover lesser-known brain circuitry and provide an opportunity to discover improved therapies.
Key eligibility criteria:
- Any sex, age 18 and up
- Patients with Parkinson’s disease, dystonia, essential tremor or other movement disorder who will undergo deep brain stimulator treatment
- Patients with epilepsy who will undergo deep brain stimulator treatment
- Fluent in English
- Excludes: history of seizure in movement disorder patients, bleeding disorder (cortical electrodes contraindicated), pregnancy
Contact person: Brigette Vaughn, 314-273-0368, b.vaughn@wustl.edu
PI: Leuthardt
Protocol ID: 202101161
Short study title: The Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Learning and Memory
Short description: Stimulation of the vagus nerve is currently FDA-approved for treating intractable epilepsy and chronic depression, and it is under investigation for various other applications, such as in stroke, tinnitus, and cognitive impairments. Transcutaneous auricular vagal nerve stimulation (taVNS) is a noninvasive nerve stimulation administered to the outer ear which contains a branch of the vagus nerve, and may have widespread effects on neural biology in the brain and spinal cord. taVNS may involve electrical and/or vibrotactile stimulation. The goal of this study is to understand the effect of a commercially-available taVNS device on motor learning. In addition, electroencephalogram (EEG) recordings will be collected before and after the task to understand the physiological changes as a result of taVNS. This study is looking to enroll two populations: healthy volunteers and adult patients undergoing stereotactic EEG for intractable epilepsy.
Key eligibility criteria:
- Any sex, age 18 and up
- Healthy volunteers: no known neurological deficits
- Patients: at the discretion of the treating physician
Contact person: Kara Donovan, kara.donovan@wustl.edu
Enrollment period: April 2021 – Current
PI: Leuthardt
Protocol ID: 201102222
Short study title: Brain-Computer Interface with Electrocorticography (ECoG)
Short description: Electrocorticography (ECoG) is a recording method used during brain surgery to measure brain activity. Frequency rhythms that correlate with activity of certain neuronal populations have been used to develop brain-machine interfaces to treat patients with stroke, spinal cord injury, and other neurological conditions. The ultimate goal of this project is to develop a functioning and clinically feasible brain-computer interface for motor impaired patients. Existing systems have been developed by our group to facilitate one-dimensional control, but more research is needed to provide higher-dimensional control such as moving cursors on a screen and manipulating objects in space. Patients undergoing craniotomy for implantation of subdural grids for ECoG at Barnes-Jewish Hospital or St. Louis Children’s Hospital will be eligible for this research study.
Key eligibility criteria:
- Any sex, age 5 and up
Patients will be enrolled at the discretion of the treating physician
Enrollment period: Current
PI: Leuthardt
Protocol ID: 201206006
Short study title: Human Cortical Physiology
Short description: Electrocorticography (ECoG) is a recording method used during brain surgery to measure brain activity. Frequency rhythms that correlate with activity of certain neuronal populations has been used to develop brain-machine interfaces to treat patients with stroke, spinal cord injury, and other neurological conditions. Despite the importance of these brain wave oscillations, the underlying mechanisms and networks are still largely unknown. The goal of this study is to perform ECoG measurements in patients undergoing open brain surgery to map and understand areas involved with important functions such as movement, sensation, and language.
Key eligibility criteria:
- Any sex, age 18 and up
Patients will be enrolled at the discretion of the treating physician
Enrollment period: Current
PI: Leuthardt
Protocol ID: 202006060
Short study title: Brain-Computer Interface with Scalp Electroencephalography (EEG)
Short description: Brain-computer interfaces offer the potential to treat patients with stroke, spinal cord injury, and other neurological conditions. Electroencephalography (EEG) is a non-invasive and safe method to sense brain activity from the scalp surface. These signals, however, are difficult to interpret because of their low frequency and spatial resolution, but newer computational methods might help to overcome these challenges. The goal of this project is to better understand and decode these signals for the goal of developing a viable brain-computer interface for patients with severe motor disabilities.
Key eligibility criteria:
- Any sex, age 18 through 80
- Healthy volunteers
Contact person: Eric Leuthardt, leuthardte@wustl.edu
Enrollment period: March 2020 – Current
PI: Leuthardt
Protocol ID: 202103016
Short study title: Recording Brain Activity from Scalp Electroencephalography (EEG)
Short description: Electroencephalography (EEG) is a non-invasive and safe method to sense brain activity from the scalp surface. The EEG device is a lightweight portable headset. It is easy to apply and remove, and it does not require any preparation of the skin or hair. It
collects information from several points on the head and sends it wirelessly to a nearby computer. The goal of this project is to better understand and decode these signals when the wearer is awake and when there is a tactile stimulation. Information gathered from this study may help to develop next generation brain-computer interfaces.
Key eligibility criteria:
- Any sex, age 18 through 50
- Healthy volunteers
Contact person: Darcy Denner, drdenner@wustl.edu
Enrollment period: March 2021 – Current