Concussion

Nexalin Technology Announces Positive Results of Clinical Study Validating its Gen-2 tACS Device for Reducing Pain Among Veterans with Mild Traumatic Brain Injury at University of California, San Diego

Retrieved on: 
Thursday, March 28, 2024
MEG, Development, Psychiatry, Veteran, Physician, Post-traumatic stress disorder, NSI, Analysis of variance, Patient, UC, RPQ, Jesse Russell, Radiology, Human services, PCS, Concussion, Trial of the century, University, McGill Pain Questionnaire, Brain damage, Pain, ANOVA, Vaccine, PTSD, MPQ, Medical imaging

HOUSTON, TEXAS, March 28, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) today announced the positive results of a clinical study evaluating Nexalin’s Gen-2 tACS device for reducing pain in veteran patients with Mild Traumatic Brain Injury (mTBI). The study was conducted at The University of California, San Diego, and is further detailed in an abstract co-authored by the United States Department of Veterans Affairs (VA) San Diego Healthcare System, and the Radiology, Psychiatry and Neurosciences Departments of UC San Deigo.

Key Points: 
  • mTBI is a leading cause of sustained physical, cognitive, emotional, and behavioral deficits in veterans and the general public.
  • However, the underlying pathophysiology is not completely understood, and there are few effective treatments for post-concussive symptoms (PCS).
  • The study was conducted as a randomized, double-blind, placebo-controlled clinical trial over an eight-week period, with two groups being examined: an active tACS group and a sham tACS group.
  • Mark White, CEO of Nexalin Technology, stated, "We are encouraged by the results of the clinical study, reinforcing the significant reduction in pain and other persistent symptoms of mild traumatic brain injury among veteran patients.

NeuroCatch Introduces PeakSelect, Enabling a Deeper Clinical Dive into Brain Vital Signs at a Doctor's Office Near You

Retrieved on: 
Tuesday, April 9, 2024
Research, MD–PhD, Blood pressure, Neurology, Brain, Concussion, Mass General Brigham, Vital signs, Clinical, Neuro, Patient, Mental health, Thermoregulation, MD, Athlete, Medicine, Detroit Lions, Dementia, Sport, ERPs, Medical device

BOSTON, April 9, 2024 /PRNewswire/ -- NeuroCatch Inc., a leading medical device company that enables rapid access to an objective assessment of brain health at the point of care, today announced the release of PeakSelect, an innovative software tool designed to improve clinical decision making. An enhancement to the NeuroCatch Platform, PeakSelect allows users to evaluate specific brain vital sign responses for precision medicine in patients undergoing portable neuro-physiological brain function assessment.

Key Points: 
  • An enhancement to the NeuroCatch Platform, PeakSelect allows users to evaluate specific brain vital sign responses for precision medicine in patients undergoing portable neuro-physiological brain function assessment.
  • "The first of an ongoing cadence of planned software upgrades, PeakSelect enhances the impact of NeuroCatch's brain health vital sign data to inform better clinical decision-making, more robust clinical trials, and more effective training regimes."
  • Through regular, over-the-air updates, NeuroCatch is continually advancing the powerful impact of brain vital sign monitoring for frontline health impacts.
  • "The NeuroCatch platform has already proven itself a breakthrough device with its mobile ability, rapid analysis and sophisticated sensitivity to analyze brain vital sign data.

WaveDancer and Firefly Neuroscience, an AI-Driven Brain Health Company, Each Receive Respective Stockholder Approvals for Merger

Retrieved on: 
Monday, March 18, 2024
Depression, Plan, ADHD, Concussion, Patient, AI, Brain, My Little Pony, Anxiety, WAVD, FDA, FFN, Dementia, Food

FAIRFAX, Va., March 18, 2024 (GLOBE NEWSWIRE) -- WaveDancer, Inc. (“WaveDancer”) (Nasdaq: WAVD) and Firefly Neuroscience, Inc. (“Firefly”) an AI-driven brain health company, each received the requisite stockholder approvals required to consummate the merger between both companies.

Key Points: 
  • FAIRFAX, Va., March 18, 2024 (GLOBE NEWSWIRE) -- WaveDancer, Inc. (“WaveDancer”) (Nasdaq: WAVD) and Firefly Neuroscience, Inc. (“Firefly”) an AI-driven brain health company, each received the requisite stockholder approvals required to consummate the merger between both companies.
  • The Firefly approval was obtained through a written consent by the holders of a majority of the outstanding voting shares of Firefly.
  • "The WaveDancer favorable shareholder vote is an important step in consummating the merger and reinventing WaveDancer as an AI-enabled neurological health platform,” said Jamie Benoit, Chairman and CEO of WaveDancer.
  • WaveDancer has filed with the SEC a Registration Statement, which includes a proxy statement/prospectus of WaveDancer that sets forth relevant information pertaining to the merger.

Nexalin Technology Announces Poster Presentation at “State of the Technology Meeting: Neurotrauma Diagnosis, Monitoring, and Assessment”

Retrieved on: 
Wednesday, March 13, 2024
Diagnosis, Depression, Washington Convention Center, Government, Development, Veteran, Walter, Patient, Insomnia, Concussion, TBI, Anxiety, MTEC, Chronic pain, Traumatic brain injury, Dementia, PTSD, Medical device

HOUSTON, TEXAS, March 13, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW), today announced it was selected and provided a poster presentation at the “State of the Technology Meeting: Neurotrauma Diagnosis, Monitoring, and Assessment” on March 12, 2024, which was held at the Walter E. Washington Convention Center in Washington, D.C.

Key Points: 
  • The U.S. Army Medical Research and Development Command’s (USAMRDC) Combat Casualty Care Research Program (CCCRP) Neurotrauma Portfolio and the Biomedical Advanced Research and Development Authority (BARDA), with support of MTEC, hosted the State of the Technology meeting focused on non-invasive neuroassessment tools.
  • This was an ideal venue for our poster presentation as the conference attendees included many of the leading thought leaders and decision-makers from both the public and private sectors.
  • Notably, both the DoD and BARDA’s concerns continue to grow surrounding TBI, and we’re seeing the US Government significantly invest in new, non-drug therapeutic options to address TBI in support of struggling warfighters and veterans.
  • We could not have been more pleased with the overwhelming response to our presentation and look forward to providing more details on our latest study in an upcoming abstract publication.”

Astrocyte Pharmaceuticals Announces FDA Clearance of its Investigational New Drug Application for AST-004

Retrieved on: 
Tuesday, March 12, 2024
Diagnosis, Stroke, Brain, Patient, Concussion, TBI, Death, IND, Traumatic brain injury, Investigational New Drug, Yale school, FDA, Health, Food, Pharmaceutical industry

The IND application clearance also paves the way for additional studies further exploring AST-004 in stroke, as well as TBI, and concussion.

Key Points: 
  • The IND application clearance also paves the way for additional studies further exploring AST-004 in stroke, as well as TBI, and concussion.
  • And it has the potential to treat stroke occurring in any sized blood vessel in the brain.
  • Astrocyte previously completed two Phase 1 safety trials in Europe, involving 80 participants in total, and saw no significant adverse effects or safety concerns.
  • Dr. William Korinek, CEO of Astrocyte Pharmaceuticals, commented, “Since our founding in 2014, we have been focused on demonstrating the potential of cerebroprotective benefits of AST-004.

Oragenics, Inc. Files 10K and Provides Company Update

Retrieved on: 
Monday, April 1, 2024
General Health, Finance, Accounting, Health, Professional Services, Annual report, Brain, Concussion, Security (finance), Contract research organization, Bank statement, DSM-IV codes, Government, Pharmaceutical industry

The Company is pleased to report it has executed on its strategy to diversify its product development portfolio and makes progress in transforming the Company to create long term value.

Key Points: 
  • The Company is pleased to report it has executed on its strategy to diversify its product development portfolio and makes progress in transforming the Company to create long term value.
  • Some key items that have helped to improve the Company moving forward are:
    The Company acquired a platform technology intended to treat multiple neurological disorders.
  • We are excited about the progress the Company has made in the past several months.
  • See further discussion in footnote 1 of the Company’s consolidated financial statements included in the Company’s Annual Report on Form 10-K.

Oragenics Appoints James Kelly MD, Chief Medical Officer, to Lead Phase II Clinical Trials for Treating Concussion

Retrieved on: 
Monday, March 18, 2024
Pharmaceutical, Health, Neurology, Clinical Trials, Depression, Metabolism, Brain, NCE, Acute stress disorder, Concussion, Veterans' affairs, Executive, Common, Inflammation, Patient, United States Congress, TBI, Foundation (nonprofit), Anxiety, CTE, University, Military personnel, Oxidative stress, Human, GMP, Nasal cavity, Traumatic brain injury, DSM-IV codes, Phase, Traffic, Swelling, FDA, Animal, Pentagon, Chronic traumatic encephalopathy, Phase II, Marcus Foundation, Medical device

Oragenics’ lead drug candidate, ONP-002 is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (TBI), aka concussion.

Key Points: 
  • Oragenics’ lead drug candidate, ONP-002 is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (TBI), aka concussion.
  • Dr. Kelly was also National Director of the Avalon Action Alliance TBI Programs for which the MIBH serves as the clinical coordinating center.
  • “I am excited to join Oragenics as its Chief Medical Officer at such an important and pivotal time in the drug development process.
  • Dr. Kelly has interacted with the FDA and clinical trials for brain injury throughout his esteemed career.

Study led by Akron Children's finds pro2cool's hypothermic therapy reduces adolescent concussion symptoms

Retrieved on: 
Tuesday, April 2, 2024
RN, Brain, Head, Medicine, Concussion, Ageing, Dayton Children's Hospital, Research, University, Doctor of Philosophy, University of Michigan, Frank R. McNinch, Adolescence, E pluribus unum, Hospital, Pain, Ice, Food, Swelling, FDA, Northeast Ohio Medical University, Parent, Neck, Sports medicine, Medical device

AKRON, Ohio, April 2, 2024 /PRNewswire/ -- Researchers at Akron Children's, Cincinnati Children's, University of Michigan and Dayton Children's Hospital, have found that hypothermic therapy reduces symptom severity after concussion.

Key Points: 
  • AKRON, Ohio, April 2, 2024 /PRNewswire/ -- Researchers at Akron Children's, Cincinnati Children's, University of Michigan and Dayton Children's Hospital, have found that hypothermic therapy reduces symptom severity after concussion.
  • After a second treatment using the pro2cool® system, SCAT5 scores were 25% lower than those receiving standard concussion care.
  • It is the first and only concussion treatment study of this population, and the largest single concussion therapy trial known to date.
  • Now, in addition to brain rest, concussion symptoms can be treated with selective hypothermic therapy.

Abbott Receives FDA Clearance for Whole Blood Rapid Test to Help with Assessment of Concussion at the Patient's Bedside

Retrieved on: 
Monday, April 1, 2024
Brain, Plasma, Head, L1, Concussion, Serum, GFAP, Patient, Biomarker, Research, TBI, Triage, University, Neurosurgery, Doctor of Philosophy, Glial fibrillary acidic protein, Head Injuries, Pediatrics, Traumatic brain injury, Hospital, San Francisco General Hospital, Glasgow Coma Scale, FDA, Health, Food, Medical imaging

The whole blood test on a portable instrument helps clinicians evaluate patients 18 years of age and older who present with suspected mild traumatic brain injury or mTBI, commonly known as concussion.

Key Points: 
  • The whole blood test on a portable instrument helps clinicians evaluate patients 18 years of age and older who present with suspected mild traumatic brain injury or mTBI, commonly known as concussion.
  • Test results can help rule out the need for a CT scan of the head and assist in determining the best next steps for patient care.
  • The i-STAT TBI cartridge with the i-STAT Alinity System requires a small venous blood sample, which is applied to the test cartridge.
  • Now, we have a whole blood test that can help assess the brain right at the patient's bedside – expanding access to more health providers and therefore patients."

Student-Athletes with Self-Reported Autism Spectrum Disorder are More Likely to Score Low on Common Concussion Test, Raising the Need for Autism-Specific Comparison Data

Retrieved on: 
Thursday, March 28, 2024
Research, School, Immediate, Archive, Learning, Saint Joseph's University, Impact, ADHD, Prevalence, Exercise, DSM-IV codes, Support, Concussion, University, Doctor of Philosophy, Athlete, Attention deficit hyperactivity disorder, Psychology, Neuropsychology, Spectrum, Multimedia, FDA, ASD, Medicine, Dietary supplement

PHILADELPHIA, March 28, 2024 /PRNewswire/ -- Schools and colleges across the country rely on Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) evaluations to assess and manage student-athlete concussions on the sidelines. However, this FDA-cleared tool is not recommended for student-athletes with neurodevelopmental disorders, who often score significantly lower than neurotypical individuals. New research published Feb. 13 in the Archives of Clinical Neuropsychology demonstrates the need for alternative or modified concussion assessment norms and the need for baseline testing for autistic athletes.

Key Points: 
  • However, this FDA-cleared tool is not recommended for student-athletes with neurodevelopmental disorders, who often score significantly lower than neurotypical individuals.
  • "The [neuropsychology] field needs to expand assessment and interpretation practices and procedures for people with ASD and related developmental conditions."
  • Individuals with attention deficit hyperactivity disorder (ADHD), learning disorder (LD) and ASD are not included in normative reference data.
  • This means when autistic athletes are assessed for a concussion, their data is compared to age- and gender-similar neurotypical individuals.