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21 active trials for Deep Brain Stimulation

Cortical Network Modulation by Subthalamic Nucleus DBS

Deep brain stimulation of the subthalamic nucleus (STN DBS) in Parkinson's disease (PD) can provide substantial motor benefit yet can also produce unwanted mood and cognitive side effects. Although the neural mechanisms underlying benefits and side effects are not well understood, current hypotheses center on the potentially measurable yet currently undefined effects within downstream cortical networks. Limitations of current tools have impeded attempts to assess network connectivity directly and dynamically in humans with implanted DBS; PET lacks the necessary temporal resolution while fMRI is neither optimal nor safe for patients with implanted DBS. In this proposal, to overcome these significant limitations, the investigators apply high-density diffuse optical tomography (HD-DOT) methods to investigate how STN DBS modulates cortical functional networks and behavior in PD patients. HD-DOT uses a collection of functional near-infrared spectroscopy (fNIRS) measurements, free of radiation exposure concerns, and without electrical/metal artifacts or contraindications or safety concerns for DBS. However, common fNIRS systems are critically hampered by typically sparse measurement distributions that lead to poor anatomical specificity, unreliable image quality due to crosstalk with scalp signals, poor spatial resolution, limited field of view, unstable point spread functions, and uneven spatial coverage. HD-DOT solves these problems by using high-density interlaced source and detector imaging arrays that support densely overlapping measurements and anatomical head models that together result in higher spatial resolution, stable point spread functions, and greatly improved isolation of brain signals from scalp signals. The investigators have demonstrated that HD-DOT accurately maps functional connectivity (FC) within and between cortical resting state networks (RSNs) in the outer ~1cm of cortex with comparable temporal and spatial resolution to fMRI. Preliminary data in older controls and STN DBS patients that directly establish validity and feasibility for the proposed studies are provided. A recent comprehensive evaluation of FC in PD (without DBS) using fMRI found reduced within-network FC in visual, somatomotor, auditory, thalamic and cerebellar networks and reduced between-network FC involving predominantly cortical RSNs (somatomotor, sensory and association), some of which correlated with cognitive and motor dysfunction in PD. Notably, striatal RSNs were not abnormal. These data suggest that PD affects the interrelationships of cortical networks in a behaviorally meaningful way, far downstream of focal subcortical neuropathology. STN DBS is known to alter activity in downstream cortical regions that function as nodes within these dynamic cortical networks supporting movement and cognition. Thus, cortical network FC may play a critical role in mediating the impact of STN DBS on motor and non-motor behavior. Location of the stimulating contact may further modulate these downstream effects, due to the complex functional organization of the STN region. Study procedures include motor and cognitive tests, questionnaires, HD-DOT scanning, and MRI scans. The investigators propose to investigate how STN DBS influences downstream cortical network FC using HD-DOT. This information could lead to more efficient clinical optimization of DBS, identify potential cortical targets for less invasive neuromodulation, and lay the groundwork for future more complex experimental manipulations to determine the full range of STN DBS-induced cortical network responses to up-stream focal electrical perturbations, revealing fundamental properties of functional network plasticity.

Saint Louis, MissouriStart: April 2021
Ketamine in Deep Brain Stimulation (DBS) Surgery

Deep brain stimulation (DBS) is a well-established and effective treatment for motor symptoms resulting from idiopathic Parkinson's disease (PD). During the DBS surgery , a brain electrode is implanted in the basal ganglia, which is involved in the pathophysiology of the disease. The surgery consists of three steps: 1. Opening the skin, drilling the skull bone and inserting a temporary electrode. 2. Recording electrical activity of the brain, electrical stimulation of the brain which guide the implantation of the electrode.3 Transferring wires and implanting a subcutaneous pacemaker battery in the chest area. Today, standard treatment protocols consist undergoing the second stage (or first and second stage, depending on the treatment center protocol) of the surgery awake (under local anesthesia only). As systemic anesthetics affect cerebral electrical activity and prevent patient cooperation, they inhibit precise identification of the cerebral target under 'physiological navigation' guided by electrical recording and brain stimulation. As a result, the accuracy of electrode implantation decreases. However, undergoing surgery in an awake format often causes severe patient discomfort and anxiety necessitating shortening the length of surgery or aborting the surgery. As such there is a need for establishing an alternative anesthesia protocol for DBS surgeries. Ketamine is considered a unique anesthetic due to its hypnotic properties, analgesia, and possible amnesia. Standard doses of ketamine are currently used worldwide to treat patients with various injuries and brain diseases. Research from monkeys has shown that ketamine (in low dose) does not affect electrical brain activity used for physiological navigation. The investigators therefore propose a prospective , randomized , blinded study to evaluate the utility of low dose of ketamine in the second stage of DBS surgeries for increasing patient satisfaction and cooperation without detracting from the accuracy of physiological navigation to the cerebral target. This study will compare two treatment arms : Treatment arm consisting of patients randomized to receive a low dose of ketamine for the second stage of DBS surgery. Control arm consisting of patients randomized to receive sham control of saline during the second stage of DBS surgery.

Petah tikvaStart: January 2021
Deep Brain Stimulation With LIFUP for Mild Cognitive Impairment and Mild Alzheimer's Disease

The purpose of the proposed study is to determine the feasibility of brief brain stimulation, using a device called Low Intensity Focused Ultrasound Pulsation (LIFUP), for persons with mild cognitive impairment (MCI) or mild (early-stage) Alzheimer's disease (AD). As a secondary aim, the investigators will explore whether this brief intervention is associated with improvements in cognitive functioning immediately and one week following the intervention. Subjects will be randomly assigned to one of two experimental groups: either the LIFUP administration will be designed to increase the activity of neurons in a certain part of the brain or decrease the activity of neurons. The investigators will study up to 8 subjects with MCI or mild AD. Initially, subjects will undergo a screening assessment with a study physician to determine medical and psychiatric history, establish AD diagnosis, and undergo a blood draw, if standard recent labs for dementia and EKG are unavailable. Subjects that meet criteria and agree to participate in the study will undergo a follow-up visit. In the baseline measurement visit, participants will first undergo neuropsychological testing. Participants will be randomly assigned to one of two LIFUP pulsing paradigms. Participants will then be administered four successive LIFUP treatments while the participants are in a functional magnetic resonance imaging (MRI). Sixty minutes following the administration, participants will undergo a second neuropsychological test. A final follow-up assessment will be administered at one week.

Los Angeles, CaliforniaStart: October 2018