Objective: A multi-site double-blinded pivotal randomized controlled trial (RCT) with an open label extension (OLE) study has been initiated to evaluate the safety and efficacy of twice-daily treatment with a non-invasive brainstem modulation device for the adjuvant treatment of symptoms of Parkinson’s Disease (PD). The primary objective is to evaluate the safety and efficacy of device treatments for reducing nonmotor symptom burden in PD. Secondary objectives are to establish whether device treatments provide clinically meaningful benefits and provide improvements in the following: global function, motor-related activities of daily living, motor symptoms and quality of life for participants diagnosed with PD.

Background: Previous RCTs have demonstrated that non-invasive brainstem modulation can be self-administered in the home setting using the solid-state device that delivers time-varying caloric vestibular stimulation (tvCVS)^1-3.  Results of these studies provided evidence that tvCVS may have efficacy across multiple indications including PD and that tvCVS is associated with high tolerability, treatment adherence and allocation blinding.

Method: 218 non-demented PD patients with at least a moderate burden of nonmotor symptoms and who are taking stable doses of oral anti-Parkinsonian medications will be randomized (1:1) to self-administer treatments with the device using one of two investigational treatment modes (stimulation patterns) in the home setting over 12 weeks. Participants will then enter the OLE during which all participants will self-administer twice-daily treatment for 12 weeks with a treatment mode that was reported to provide benefit in a previous PD clinical trial. Participants will be followed for 16 weeks post-treatment-cessation and then will recommence self-administration of the twice-daily treatments for an additional 8 weeks.

Results: Data collection is currently ongoing; however, in a previous single site RCT, device treatments were associated with robust, clinically meaningful and partially durable improvements across a broad spectrum of motor and non-motor symptoms in PD with an absence of significant risk to balance, gait, or safety.

Conclusion: This pair of studies will provide critical data to evaluate device treatments as a safe and effective adjuvant treatment for addressing multiple unmet needs for PD patients.

References: 1. Wilkinson D, Ade KK, Rogers LL, et al. Preventing Episodic Migraine With Caloric Vestibular Stimulation: A Randomized Controlled Trial. Headache 2017;57:1065-1087.
2. Wilkinson D, Podlewska A, Banducci SE, et al. Caloric vestibular stimulation for the management of motor and non-motor symptoms in parkinson’s disease: Intention-to-treat data. Data Brief 2019;25:104228.
3. Wilkinson D, Podlewska A, Banducci SE, et al. Caloric vestibular stimulation for the management of motor and non-motor symptoms in Parkinson’s disease. Parkinsonism Relat Disord 2019;65:261-266.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/noninvasive-brainstem-modulation-for-the-treatment-of-nonmotor-symptoms-in-parkinsons-disease-a-randomized-controlled-trial-and-open-label-extension-study/