Latest News in Parkinson Disease: Gene Therapy Clinical Trials, FDA Approves Novel DBS System, and More

An overview of the latest news in Parkinson disease (PD) reported across MJH Life Sciences^™.

Two Clinical Trials Assessing Novel Gene Therapies in PD Underway

As reported by NeurologyLive^®, Bayer announced updates on their phase 1 and phase 1b clinical trials of gene therapies for the treatment of PD. In the phase 1 study, BlueRock Therapeutics, a subsidiary of Bayer, began administering doses of its DA01 candidate, a gene therapy consisting of pluripotent stem cell–derived dopaminergic neurons.

Designed to innervate the putamen, the investigational therapy seeks to reverse the degenerative process and potentially restore motor function in people with PD, a benefit that has yet to be achieved.

For the phase 1b trial assessing glial cell line–derived neurotrophic factor (GDNF) gene therapy, manufacturer Asklepios BioPharmaceutical, another subsidiary of Bayer, has begun enrolling patients to examine the preliminary efficacy and safety of the 1-time treatment. Providing a continuous production of GDNF, the therapy is designed to promote the survival and functioning of brain cells associated with degeneration in PD.

Novel DBS System Gains FDA Approval in Treatment for Movement Disorders

Last week, the FDA approved Medtronic’s SenSight Directional Lead System for deep brain stimulation (DBS) therapy, the first directional, sensing-enabled lead designed to enhance the detection of local field potentials (LFPs) in the treatment of symptoms associated with PD and other movement disorders.

As reported by NeurologyLive^®, LFP brain signals correlate with the severity of PD symptoms and are 1 million times smaller than DBS stimulation pulses. When pairing it with the Percept PC device, the system will expand on Medtronic’s BrainSense technology, enabling clinicians to capture and record enhanced, directional LFP information from the implanted lead.

Furthermore, in detecting LFPs, clinicians can then correlate these brain signals with stimulation and events capturing medication, symptoms, and adverse effects, which will provide patients with a personalized, data-driven therapy that would be adjusted as treatment needs evolve.

Integrating Advanced Practice Clinicians in Care of Neurologic Conditions

In an interview with NeurologyLive^®, Calli L. Cook, NP, DNP, nurse practitioner, Woodruff School of Nursing at Emory University, spoke on the reluctance among neurologists in integrating advanced practice clinicians, also known as advanced practice providers (APPs), in the neurology field.

Discussing her viewpoint editorial on the issue, Cook said that neurologists have concerns on integrating APPs due to issues such as return on investment implications, the potential financial and mental stress of replacing an APP, and the time it takes to have them fully comfortable with the system of care. Moreover, APPs have voiced their own concerns that align mostly with those of neurologists, including monetary issues and fear of having their voices marginalized.

Able to assist with seeing urgent new and returning patients in the office, expediting admissions and discharges, and patient education, Cook said that a multilevel effort is warranted to incorporate APPs into common multidisciplinary neurology care.