The clinical study, dubbed OrcHESTRAS, is a prospectively enrolled study that will further characterise the long-term economic and clinical benefits of MR-001, along with its patient engagement and therapeutic response durability
US-based digital therapeutics company MedRhythms has selected Curavit Clinical Research as its virtual contract research organisation (VCRO) for the study of its neurorehabilitation system, MR-001.
The MR-001 system leverages Rhythmic Auditory Stimulation (RAS) technology to improve walking and ambulation in adults with walking impairments.
The study, dubbed OrcHESTRAS, will further characterise the long-term economic and clinical benefits of MR-001, beyond what has been established in a previous randomised clinical trial.
It is a prospectively enrolled study that will also evaluate patient engagement and therapeutic response durability of treatment using MR-001.
MedRhythms president and co-founder Owen McCarthy said: “As innovators in healthcare, it’s essential to show that new technologies not only have the power to transform patients’ lives but are also economically prudent. Health economics research quantifies the long-term financial impact on patients, providers, and payers.
“Curavit’s tech-enabled approach to research lets us launch quickly while delivering a premier experience for everyone involved.
“As important, the study will be open to participants nearly nationwide, thanks to Curavit’s virtual site solution, patient recruitment process, and smart strategies for collecting real-world healthcare economics data.”
The 12-month clinical study will enrol 225 participants by the end of the year.
Curavit will manage all the activities related to the hybrid decentralised clinical trial (DCT), including protocol finalisation and Institutional Review Board (IRB) approvals.
Also, the CRO will be responsible for patient recruitment, testing at physical sites and remote sites, patient monitoring, healthcare economics and outcomes analysis.
The partnership between Curavit and MedRhythms was initiated in June this year.
Curavit CEO and co-founder Joel Morse said: “We are honoured to work with MedRhythms to manage such an important study of an innovative neurorehabilitation system to help stroke patients improve walking without invasive therapy or pills.
“We believe it is going to become increasingly important for DTx companies to capture health economics data to enable broader market access.”