Brainstem Modulation Therapy for the Management of Parkinson's Disease: Results from a Single-Site Randomized Controlled Trial
Ade K, Wilkinson D, Podlewska A, Banducci SE, Pellat-Higgins T, Bodani M, Sakel M, Smith L, and LeWitt P. Brainstem Modulation Therapy for the Management of Parkinson's Disease: Results from a Single-Site Randomized Controlled Trial. J Mov Disord 2019; 34:S8.
J Mov Disord
Objective: To evaluate the feasibility and efficacy of a caloric vestibular stimulation (CVS)-mediated brainstem modulation device for the treatment of non-motor and motor symptoms in Parkinson's disease (PD). Background: A recent case study showed that repeated sessions of CVS using a solid-state ThermoNeuroModulation (TNM™) device, developed by Scion NeuroStim, LLC, relieved motor and non-motor symptoms associated with PD. Here, we sought to confirm these results in a prospective, double-blind, randomized, placebo treatment-controlled study. The TNM device delivers CVS via continually-varying thermal waveforms through aluminum ear-probes mounted on a wearable headset. Unlike conventional air and water irrigators, treatments can easily be self-administered at home with few side effects and with a high degree of dose control. Methods: 33 PD subjects receiving stable anti-Parkinsonian therapy completed an active (n=16) or placebo (n=17) treatment period. Subjects self-administered TNM treatments at home twice-daily. 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 Conclusions: The results provide evidence that repeated CVS can provide safe and enduring adjuvant relief for motor and non-motor symptoms associated with PD.