#USA #Houston #Neuronoff #Injectrode #Neurogenic Bladder

Neuronoff Launches Groundbreaking Clinical Trial for Injectrode Device

Neuronoff, Inc., a promising player in the field of clinical neuromodulation, recently made headlines by implanting the first patient in a clinical trial funded by the Department of Defense (DOD). This significant trial focuses on the Injectrode device, which is intended to treat neurogenic bladder in individuals who have suffered spinal cord injuries. Conducted at UT Health Houston, the trial is led by the distinguished Dr. Argyrios Stampas, MD, MS, who has a solid background in Physical Medicine and Rehabilitation. This trial is particularly noteworthy as it represents a collaborative effort funded by the Congressionally Directed Medical Research Programs (CDMRP) and the DOD.

Understanding Neurogenic Bladder

Neurogenic bladder is a prevalent and often debilitating consequence of spinal cord injuries, impacting numerous patients. This condition can lead to serious complications such as urinary tract infections, kidney damage, and a diminished quality of life. Traditional treatments have relied on tibial nerve stimulation, which has proven effective in previous studies. For instance, a randomized controlled trial in 2024 revealed that 95% of patients who received tibial nerve stimulation were able to reduce or eliminate their medications for overactive bladder, in stark contrast to only 68% in the sham control group.

Unfortunately, existing therapies come with their challenges, particularly concerning accessibility and patient experience. The requirement for surgical incisions to access the tibial nerve has limited the treatment's availability since spinal cord injury often leads to complications such as lower extremity edema. This made it difficult for patients to pursue surgical options comfortably.

The Injectrode: A Minimally Invasive Solution

The Injectrode device is revolutionizing treatment approaches with its innovative design and application process. Unlike traditional methods, the Injectrode can be implanted using a single 18-gauge needle, requiring only local anesthesia and avoiding the need for surgical incisions or sutures. Once placed next to the tibial nerve, the device's helical electrode anchors naturally in the tissue, establishing a reliable connection between the nerve and an external pulse generator. The generator emits stimulation signals aimed at restoring bladder function.

Dr. Stampas expresses optimism about the advancements this trial heralds. He elaborates, “We have consistently shown that tibial nerve stimulation can significantly alleviate medication dependence for bladder control in patients with spinal cord injury. However, finding a reliable non-surgical delivery method has been a challenge. I am thrilled by the small entry point for the procedure, as it promises to mitigate wound healing issues commonly faced by these patients.”

Key Challenges and Solutions

The co-investigator Dr. Ajai Sambasivan notes that accurately locating the nerve through ultrasound and confirming it with electrical test stimulation ensures straightforward placement of the Injectrode. The unique design of the device was crafted to allow it to be optimally positioned near the target nerve while maintaining a stable and consistent implant site.

The Injectrode is more than just a device; it represents a significant shift in treatment philosophy. “Our ambition is to empower patients right from the beginning of their treatment journey. This minimizes the need for invasive procedures and makes therapeutic options more accessible,” comments Neuronoff’s CEO, Manfred Franke. He emphasizes that the device aims to provide users the flexibility to participate in therapy within the comfort of their homes, enhancing their overall experience and quality of life.

Upcoming Study Details

As described in the ClinicalTrials.gov entry (NCT07264868), the trial will enroll 21 participants facing chronic spinal cord injury and neurogenic bladder. Over the study, patients are divided into three groups – unilateral active stimulation, bilateral active stimulation, and sham stimulation. The primary focus for evaluation will be device performance through safety metrics, stimulation accuracy, procedural viability, and acceptability from both physicians and patients. Additionally, assessments will gauge improvements in bladder function and the need for overactive bladder medication.

The data gleaned from this clinical trial is expected to be pivotal for future FDA submissions and the design of upcoming trials aimed at broader applications for the Injectrode platform.

About Neuronoff

Neuronoff is at the forefront of transforming pain management and neuromodulation strategies through its innovative platform. Based in Cleveland, Ohio, its technological advances promise to streamline treatment for multiple conditions spanning bladder issues to chronic pain—without the necessity for surgical means. The Injectrode device holds the potential to change the landscape of neuromodulation therapy permanently, marking a promising future for patients with neurogenic bladder and other related conditions.

Funding for this cutting-edge trial has been provided by various military health sectors, emphasizing a commitment to innovative care models tailored for those with spinal cord injuries. As participant recruitment continues, the medical community eagerly anticipates the insights that will emerge from the trial and how they could shape the future of neuromodulation therapies.