David Wilkinson1, Aleksandra Podlewska2, Sarah E Banducci3, Tracy Pellat-Higgins4, Martin Slade5, Mayur Bodani6, Mohamed Sakel7, Lanty Smith3, Peter LeWitt8, Kristen K Ade3. 1. School of Psychology, University of Kent, Canterbury, UK. Electronic address: dtw@kent.ac.uk. 2. School of Psychology, University of Kent, Canterbury, UK. 3. Scion NeuroStim, LLC, Durham, NC, USA. 4. Centre for Health Services Studies, University of Kent, Canterbury, UK. 5. Yale University, School of Public Health, New Haven, CT, 06510, USA. 6. Neuropsychiatry Service, Kent & Medway NHS and Social Care Partnership Trust, UK. 7. East Kent Neuro-Rehabilitation Service, East Kent Hospitals University NHS Foundation Trust, Canterbury, UK. 8. Parkinson's Disease & Movement Disorders Program, Henry Ford Hospital and Wayne State University School of Medicine, West Bloomfield, MI, 48322, USA.
Abstract
INTRODUCTION: A recent case study showed that repeated sessions of caloric vestibular stimulation (CVS) relieved motor and non-motor symptoms associated with Parkinson's disease (PD). Here we sought to confirm these results in a prospective, double-blind, randomized, placebo treatment-controlled study. METHODS:33 PD subjects receiving stable anti-Parkinsonian therapy completed an active (n = 16) orplacebo (n = 17) treatment period. Subjects self-administered CVS at home twice-daily via a portable, pre-programmed, solid-state ThermoNeuroModulation (TNM™) device, which delivered continually-varying thermal waveforms through aluminum ear-probes mounted on a wearable headset. Subjects were followed over a 4-week baseline period, 8 weeks of treatment and then at 5- and 24-weeks post-treatment. At each study visit, standardized clinical assessments were conducted during ON-medication states to evaluate changes in motor and non-motor symptoms, activities of daily living, and quality of life ratings. RESULTS:Change scores between baseline and the end of treatment showed that active-arm subjects demonstrated clinically-relevant reductions in motor and non-motor symptoms that were significantly greater than placebo-arm subjects. Active treatment was also associated with improved scores on activities of daily living assessments. Therapeutic gains were still evident 5 weeks after the end of active treatment but had started to recede at 24 weeks follow-up. No serious adverse events were associated with device use, and there was high participant satisfaction and tolerability of treatment. CONCLUSION: The results provide evidence that repeated CVS can provide safe and enduring adjuvant relief for motor and non-motor symptoms associated with PD.
RCT Entities:
INTRODUCTION: A recent case study showed that repeated sessions of caloric vestibular stimulation (CVS) relieved motor and non-motor symptoms associated with Parkinson's disease (PD). Here we sought to confirm these results in a prospective, double-blind, randomized, placebo treatment-controlled study. METHODS: 33 PD subjects receiving stable anti-Parkinsonian therapy completed an active (n = 16) or placebo (n = 17) treatment period. Subjects self-administered CVS at home twice-daily via a portable, pre-programmed, solid-state ThermoNeuroModulation (TNM™) device, which delivered continually-varying thermal waveforms through aluminum ear-probes mounted on a wearable headset. Subjects were followed over a 4-week baseline period, 8 weeks of treatment and then at 5- and 24-weeks post-treatment. At each study visit, standardized clinical assessments were conducted during ON-medication states to evaluate changes in motor and non-motor symptoms, activities of daily living, and quality of life ratings. RESULTS: Change scores between baseline and the end of treatment showed that active-arm subjects demonstrated clinically-relevant reductions in motor and non-motor symptoms that were significantly greater than placebo-arm subjects. Active treatment was also associated with improved scores on activities of daily living assessments. Therapeutic gains were still evident 5 weeks after the end of active treatment but had started to recede at 24 weeks follow-up. No serious adverse events were associated with device use, and there was high participant satisfaction and tolerability of treatment. CONCLUSION: The results provide evidence that repeated CVS can provide safe and enduring adjuvant relief for motor and non-motor symptoms associated with PD.
Authors: Nicolaas I Bohnen; Alison J Yarnall; Rimona S Weil; Elena Moro; Mark S Moehle; Per Borghammer; Marc-André Bedard; Roger L Albin Journal: Lancet Neurol Date: 2022-02-04 Impact factor: 44.182
Authors: Nicolaas I Bohnen; Prabesh Kanel; Stiven Roytman; Peter J H Scott; Robert A Koeppe; Roger L Albin; Kevin A Kerber; Martijn L T M Müller Journal: J Neural Transm (Vienna) Date: 2022-06-26 Impact factor: 3.850