FDA approved today the MicroTransponder Vivistim Paired VNS System, a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation (VNS).
My new book is out and available through Amazon!
Light of specific wavelengths and intensities has been shown to repair and protect neurons from damage, opening the possibility of using near-infrared light as a non-invasive treatment of various brain and psychiatric disorders.
This book serves as a practical overview of the scientific fundamentals, technical implementation, and therapeutic applications of transcranial photobiomodulation:
- Part I provides an accessible explanation of why the irradiation must be done in the near-infrared region of the light spectrum. It presents evidence-based background on the parameters of light important to photobiomodulation, and describes the effects of near-infrared light on cells and tissues.
- Part II discusses the types of multi-Watt light sources required to non-invasively deliver therapeutic doses of infrared light to the brain. Importantly, this part describes in detail various High-Power Near-Infrared Transcranial Therapy (HIPNITT) medical devices that have been used in clinical trials.
- Part III presents the potential and challenges of using near-infrared light in the treatment of various brain disorders such as depression, dementia, traumatic brain injury, and Parkinson’s disease.
This book uses straightforward language and offers practical guidance to help readers quickly develop an understanding of the practical aspects of HIPNITT implementation and its therapeutic applications.
Synchron Inc. announced today the first successful clinical implantation of the Stentrode®, a minimally-invasive neural interface technology, a component of the Synchron Brain-Computer Interface. This is the first clinical feasibility trial evaluating this technology for its potential to restore communication in people with severe paralysis.
Back in 2013 I reported about MicroTransponder’s Serenity System™, which pairs Vagus Nerve Stimulation (VNS) with listening to tones. During the therapy, an individual sits in a comfortable chair and wear headphones. They listen to tones while receiving small bursts of neurostimulation from the implantable vagus-nerve stimulator. UT Dallas says that “preclinical tests demonstrated that this approach “rewires” damaged brain circuitry associated with tinnitus, potentially yielding long-term reversal of symptoms. The initial human trial in Belgium provided encouraging results.”
More recently, MicroTransponder developed the Vivistim™ system intended for the treatment of stroke. The implant is based on the idea that synchronizing vagus nerve stimulation with movement increases neural plasticity in the brain, resulting in enhanced recovery.
In May 2017 MicroTransponder presented results from its Vivistim™ Stroke Rehabilitation trial. The objective of this multicenter, double-blind, randomized, active-controlled trial was to improve upper limb mobility in stroke survivors suffering chronic disability. The data showed 75% of patients had a clinically meaningful response on the Fugl-Meyer Upper Extremity Scale (FMUE) at the end of a six weeks of physical therapy compared to 33% for the control group. 90 days after the six weeks of physical therapy ended 88% of VNS patients had responded compared to 33% in the control arm. And during the long-term portion of the study average FMUE scores continued to increase, with the 6 month and 9 month data showing further gains. All responders indicated they believed their overall health had improved and were satisfied with the therapy.
At the same time, MicroTransponder announced that it had received IDE approval from the FDA to run a 120-patient pivotal trial on the Vivistim™ system.
MicroTransponders website: http://www.microtransponder.com
VeriMed’s VeriChip is the only RFID tag that has been cleared by FDA for human implant. The concept behind the medical use of the VeriChip is that patients would have the tiny chip implanted just under the skin, in the back of the arm. Each VeriMed microchip contains a unique identification number that emergency personnel may scan to immediately identify the patient and access his/her personal health information, thus facilitating appropriate treatment without delay. This is especially important for patients who suffer from conditions that may render them unconscious, confused, or unable to communicate. Although the FDA approved the use of the device for anyone 12 years of age or older, it would mostly be recommended for patients with diabetes, stroke, seizure disorders, dementia, Alzheimer’s, developmental disorders, and organ transplants.
Northstar was founded in 1999 as Vertis Neuroscience headquartered in Seattle, WA, and the original goal was to develop electrical stimulation for chronic back pain. In 2003, under its new name, Northstar Neuroscience, then developed the Renova cortical stimulation system to deliver targeted electrical stimulation to the brain cortex as a treatment for stroke-related upper extremity. Continue reading