NCNE joins four other Centers of Excellence in this company-sponsored open-label observational trial designed to evaluate the impact of subjects’ adherence to Portable Neuromodulation Stimulator (PoNS) therapy in patients with multiple sclerosis (MS). The initiative will be led by Dr. Salvatore Napoli, Medical Director of NCNE.
“Dr. Napoli and his team are important contributors to our PTAP program, and we are elated about their participation in the TEP study. NCNE is a highly reputable medical center known for its high-touch, integrated approach to treating MS and other neurological conditions. The center’s unique approach to patient care will further enhance our understanding of the impact of PoNS therapy, as applied in real-world clinical settings, on therapeutic outcome,” said Antonella Favit-Van Pelt, M.D., Ph.D., Helius’ Chief Medical Officer.
“It’s been well established that many people suffering the physical symptoms of MS are able to manage their disease progression with advanced pharmacological and non-pharmacological therapeutic interventions. PoNS therapy has shown the ability to improve gait and balance in patients with MS, and we are thrilled to include this important treatment in our broad spectrum of high-quality neurological care,” stated Dr. Napoli.
About Neurology Center of New England
The Neurology Center of New England is a comprehensive neurological care center devoted to the diagnosis, care, and management of patients with neurological diseases and syndromes. NCNE manages patients with conditions such as MS, migraine and other headache syndromes, Parkinson’s disease, neuropathy, seizure disorders and epilepsy, dementia and memory disorders, numbness, and spasticity/dystonia.
About the Therapeutic Experience Program
The Therapeutic Experience Program is a Helius-sponsored, open label observational, interventional multi-center outcome research trial designed to assess adherence to on-label PoNS therapy for improvement in gait deficits for patients with MS in a real-world clinical setting. The study will rate subjects’ adherence to PoNS therapy, which combines the PoNS device with physical therapy, to better understand the relationship between adherence to the treatment regimen and therapeutic functional outcome.
The primary endpoint of the study is maintenance of gait improvement from the end of supervised therapy (Phase 1) to the end of unsupervised therapy (Phase 2) in relation to the subject’s adherence to PoNS therapy. The secondary endpoint is improvement of gait and balance deficit over time and clinical global impression of change.
The study will be conducted at 10 to 12 Centers of Excellence across the United States, with an estimated four PoNS devices per site. Enrollment is expected to begin in the fourth quarter of 2022 and continue into 2023. A total of 50 to 60 patients with MS are expected to take part in the program.
[Source(s): Helius Medical Technologies Inc, Globe Newswire]