Noninvasive way of deep brain stimulation to be tested in patients
Pilot trial of neuromodulation via electrodes placed on the leg fully enrolled
A pilot trial into whether deep brain stimulation based on noninvasive neuromodulation of a lower leg nerve can safely and effectively ease symptoms of Parkinson’s disease and essential tremor is fully enrolled, Stimvia, its developer, announced.
The 24 patients in the study (NCT06036368) will use the company’s URIS device, which stimulates nerve pathways to the brain by modulating the electric activity of the leg’s peroneal nerve through electrodes placed on the skin.
“URIS technology offers a non-invasive, neuromodulation-based approach, potentially benefiting various neurological diseases,” David Skoloudik, MD, PhD, the trial’s principal investigator and vice dean of science and research at the Medical Faculty of Ostrava University, Czech Republic, said in a company press release.
Results of the single-site trial, taking place in that country, are expected in early 2024. If positive, Stimvia plans further studies to confirm the device’s safety and efficacy in people with Parkinson’s and essential tremor.
Potential for a noninvasive form of deep brain stimulation for Parkinson’s
Parkinson’s is caused by the progressive dysfunction and death of neurons that communicate by producing dopamine, a major brain chemical messenger. Their loss affects dopamine signaling in the brain, contributing to disease symptoms like tremor, rigidity, and bradykinesia or slowed movements.
“Patients with Parkinson’s disease are typically treated with medications to boost brain dopamine levels, but these drugs can’t halt disease progression,” Skoloudik said. “Over time, their effectiveness diminishes, leading to the need for risky surgical interventions involving neurostimulator implantation and electrode insertion in specific brain areas.”
To date, deep brain stimulation (DBS) for Parkinson’s involves surgery to place fine wires, called electrodes, into the deep structures of a patient’s brain. These electrodes are connected to a battery-powered neurostimulator device implanted under the skin, typically below the collarbone.
The device releases pulses of electrical current through the wires and into the brain, blocking the irregular signals that cause tremor and other Parkinson’s motor symptoms.
Stimvia’s URIS device aims to be a noninvasive alternative for DBS, modulating the activity of specific brain nerve pathways through electrodes placed on the skin around the peroneal nerve.
“Such precisely targeted stimulation activates brain centers that are in decline, or to inhibit overly active brain centers in order to restore balance to the brain,” the company stated on the device’s webpage. It “is the first clinically tested neuromodulation device that uses a closed-loop biofeedback system and is designed to allow treatment from the comfort of one’s home.”
A closed-loop biofeedback system allows for electrical stimuli to be given and for the brain’s response to be monitored. Essentially, monitoring records how fast or slow a patient’s brainwaves are firing, so that doctors can adjust and optimize the neurostimulation administered.
The device also uses artificial intelligence to analyze data from treatment sessions and their outcomes, noting areas for recalibration or adjustments needed in electrode placement, Stimvia reported.
Enrolled pilot trial patients — 12 with Parkinson’s and 12 with essential tremor — all are women. Those with Parkinson’s are experiencing bradykinesia, tremor, and rigidity during on periods with stable levodopa doses. On periods are times when the treatment is working as intended, while off periods are those when therapy effects wane before another dose can be taken.
24 patients using URIS nerve stimulation device at home for six weeks
They will use the URIS device in daily, 30-minute stimulation sessions for six weeks, after which they will be followed for another six weeks to monitor the persistence of treatment effects.
The study’s main goal is the approach’s safety and tolerability over its weeks of use, while efficacy is a secondary goal, determined via changes from the study’s start to week six in the clinician-assessed Patient Global Impression of Improvement scale.
Parkinson’s-specific exploratory efficacy measures include changes in overall disease and motor symptoms, and changes in quality of life. Patient satisfaction and abilities in daily life activities with treatment also will be evaluated.
The URIS nerve stimulation device previously was tested in a clinical trial (NCT05211193) in people with overactive bladder, with results showing “an 80% reduction in the incidence of undesired episodes of urge to void and a significant activation of brain structures previously involved in the perception of a bladder filling,” Stimvia reported.
“The ongoing pilot study is the first step towards confirming the effectiveness and safety of our treatment for other diagnoses,” said Lukas Doskocil, the company’s CEO.