Rigorous Clinical Trial Design

From its beginnings, Scion has been committed to conducting rigorous scientific studies to best define the role of our therapy in clinical practice. To this end, Scion has sponsored two double-blind, randomized controlled trials in Parkinson’s disease. These trials include a single site study (NCT02703844) in which study participants with motor and non-motor symptoms treated themselves twice daily with the Scion Device for eight weeks. Results from that trial, in which patients continued to receive standard medical therapy, suggest regular stimulation with the Scion Device might improve a broad range of motor and non-motor symptoms.

Current Clinical Trial Overview

Building on the robust findings of the earlier single-site randomized controlled trial, Scion has initiated a multi-center, double-blind, randomized controlled trial (STEM-PD Trial. NCT04797611). This larger trial incorporates guidance from the U.S. Food and Drug administration provided via pre-submission meetings and closely follows the design of our previous successful single-site clinical trial. The trial is being conducted at more than 20 centers in the United States and the United Kingdom, was reviewed by Parkinson’s disease patients, and involves many widely respected leaders in the field of Parkinson’s disease therapeutics.

Scion NeuroStim is actively pursuing clinical studies aimed at evaluating mechanisms of action for treatments with our device.

To learn more, please contact: research@scionneurostim.com

The primary objective of the study is to evaluate whether Scion’s device treatments provide safe and effective therapy for the reduction of non-motor symptom burden in people with Parkinson’s. This will be tested by evaluating the change total score from The International Parkinson and Movement Disorder Society Nonmotor Rating Scale (MDS-NMS) (Chaudhuri 2020), a validated clinical outcome assessment that expands upon a long-established and widely used predecessor assessment, the Non-Motor Symptom Scale (Chaudhuri, Martinez-Martin et al. 2007).

Secondary endpoints will test whether device treatments: (1) provide global benefits, (2) improve activities of daily living related to motor function, (3) provide clinically meaningful change (4) improve motor symptoms, and (5) improve quality of life (QoL) in Parkinson's disease. Enrollment in this randomized study is currently ongoing.

Learn more about the clinical study and locations here.

Scion is also supporting several other earlier stage and investigator-initiated trials exploring the potential of this therapy for specific Parkinson’s symptoms and populations, and to explore the mechanism of action. Scion is open to other investigator-led initiatives. Investigators can contact Scion at research@scionneurostim.com.