TremorStim, a Leonhardt Ventures LLC startup, unveiled today its 2nd generation combination bioelectric stimulation device for treating essential tremor comprised of an easily applied, non-invasive head and wrist band. It also announced plans to launch 2023 a multi-center clinical study with investigational sites likely to be in Brazil and Australia.
The planned multi-center trial, the Better Prospects Study, will be a 30-patient, single-arm study designed to evaluate the TremorStim 2 combination device for transient symptomatic relief in adults with essential tremors for three months, with patients undergoing two daily treatments for 40 minutes each, separated by at least two hours. The therapy protocol also includes once-a-month (3X through the full protocol) focused ultrasound treatment (both head and wrist) in a clinic for one hour and twice a week exercise regime with the patented BodStim TM www.bodstim.com bioelectric body suit for 20 to 40 minutes each.
The primary endpoints of the Better Prospect's Study will include a subset score using the Tremor Research Group's Essential Tremor Rating Assessment Scale, which rates tasks from zero to four, with a higher score indicating a more severe tremor; and a subset score using the Bain & Findley Activities of Daily Living, which rates eight tasks on the same 0-4 scale. This protocol design will soon be published on ClinicalTrials.gov. Secondary outcomes will include changes in kinematic measurements. It is the company’s goal to launch, enroll and complete all follow-ups for this study in 2023.
This past month CMS Medicare in the USA announced a benefit category and payment determination for non-invasive stimulation-driven durable medical equipment-based treatment of essential tumors that now expands patient access to any FDA-cleared non-invasive targeted therapy for hand tremor.
The principal difference between TremorStim's technology and other candidate therapies for essential tremor has to do with its patented and patent-pending precise bioelectric signaling sequences for controlling specific protein expressions such as klotho, BDNF, GDF11, and GDF10. It is the first therapeutic candidate that combines both 2X daily at-home brain/headband and wristband stimulation with once-a-month focused ultrasound treatments at a clinic.
What is Essential Tremor? Classic essential tremor is a clinical syndrome of action tremor in the upper limbs (at least 95% of patients) and less commonly the head, face/jaw, voice, tongue, trunk, and lower limbs, in the absence of other neurologic signs. However, the longstanding notion that essential tremor is a monosymptomatic tremor disorder is being challenged by a growing body of literature describing associated disturbances of tandem walking, personality, mood, hearing, and cognition. There is also epidemiologic, pathologic, and genetic evidence that essential tremor is pathophysiologically heterogeneous. Misdiagnosis of essential tremor is common because clinicians frequently overlook other neurologic signs, and, because action tremor in the hands is caused by many conditions, including dystonia, Parkinson's disease, and drug-induced tremor. Thus, essential tremor is nothing more than a syndrome of idiopathic tremulousness, and the challenge for researchers and clinicians is to find specific etiologies of this syndrome.
As mentioned above, our patented electrical signals induce the upregulation of a series of proteins, many of which directly affect brain function and a number of physiological processes. In particular, we believe that inducing the expression of the protein Klotho will have a salutary effect on brain function including reducing the incidence and duration of essential tremor. Cognitive dysfunction is a key symptom of aging and neurodegenerative disorders, such as Alzheimer’s disease (AD), Parkinson's disease (PD), and Essential Tremor. Strategies to enhance cognition would impact the quality of life for a significant proportion of the aging population. The α-klotho protein may protect against cognitive decline through multiple mechanisms: such as promoting optimal synaptic function via activation of N-methyl-d-aspartate (NMDA) receptor signaling; stimulating the antioxidant defense system; reducing inflammation; promoting autophagy and enhancing the clearance of amyloid-β.
The company shared additional pre-clinical studies are being completed before it plans to make submissions to regulatory authorities and Institutional Review Boards in the above-mentioned countries to apply to begin clinical studies.
Formed in 2017 TremorStim is an early-stage startup incubating in Leonhardt's Launchpads innovation and startup launch accelerator at University Lab Partners Wet Lab Incubator at UCI Research Park 5270 California Avenue, Irvine, CA 92617. The company has exclusively licensed from Leonhardt Ventures LLC, its founding parent company, and Neuro Code Holdings LLC, over 300 patents, including claims that may apply to bioelectric and focused ultrasound treatment of essential tremors.
About Leonhardt Ventures LLC:
The Leonhardt team has been developing innovative medical devices since(not sure why this paragraph has spacing and “carriage return” problems. 1982. See www.leonhardtventures.com Over 600,000 patients have been treated with Leonhardt inventions to date. The team has over 700 patent claims https://patents.justia.com/inventor/howard-j-leonhardt issued, pending, in process, licensed, or optioned covering longevity and wellness primarily focused on applying bioelectrics, biologics, and endovascular technologies to healing.
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