STEM-PD RCT and OLE v1.1 SNS-PD-002/SNS-PD-003
Research type
Research Study
Full title
Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson’s Disease: A Randomized Controlled Trial (RCT) and an Open Label Extension (OLE) Study
IRAS ID
300605
Contact name
K Ray Chaudhuri
Contact email
Sponsor organisation
Scion NeuroStim LLC
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT04799418, ClinicalTrials.gov OLE identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This paired set of studies seeks to establish the safety and efficacy of twice daily time-varying caloric vestibular stimulation (tvCVS) treatments using a solid-state Device developed by Scion NeuroStim, LLC (SNS), also known as ThermoNeuroModulation (TNM™), for treating symptoms associated with PD. The studies will be conducted at 15 centers, at minimum, in the United States and the United Kingdom. Up to 250 participants will first enter the double-blinded, controlled, randomized clinical trial (RCT) and will self-administer tvCVS treatments twice daily in the home setting over a period of 12 weeks (84 days). At least 176 participants will complete the RCT prior to competitive enrollment closing. The RCT will be immediately followed by an open label extension (OLE) study during which all study participants will receive treatment for 12 weeks (84 days). Study participants will be followed for 16 weeks (112 days) post treatment-cessation and then the twice daily treatments will be re-introduced for the final 8 weeks (56 days). The primary objective of the RCT will be to test the hypothesis that TNM™ treatments provide safe and effective therapy for the reduction of non-motor symptom burden in participants with PD. Secondarily, this study will seek to establish whether (1) TNM™ treatments provide adjuvant therapeutic effectiveness beyond that observed with oral dopamine replacement therapies (DRTs) to improve (1) activities of daily living related to motor function, (2) motor symptoms and (3) quality of life (QoL) for participants with PD. The OLE has been designed to address the following objectives: (1) demonstrate reproducibility of the results from the RCT in a second cohort (i.e. all participants, including recipients of active treatment and recipients of passive treatment in the RCT will receive active treatment in OLE), (2) evaluate effectiveness of the Device treatments over an extended treatment interval, (3) collect additional data to support health economic benefits, (4) confirm clinical meaningfulness of RCT results and (5) evaluate the potential for the device to slow disease progression.
REC name
London - Dulwich Research Ethics Committee
REC reference
21/LO/0619
Date of REC Opinion
2 Feb 2022
REC opinion
Further Information Favourable Opinion