A clinical investigation is set to examine the potential of Scrambler Therapy as a solution for chemotherapy-induced peripheral neuropathy (CIPN). The study, sponsored by Case Comprehensive Cancer Center and VelaSano, is not yet recruiting participants but aims to address the debilitating nerve pain and sensory disruptions faced by cancer patients undergoing treatment. Scheduled to begin soon, this research could open pathways for non-invasive device therapy options in CIPN management.
In this article:
- What is Scrambler Therapy?
- Study Design and Objectives
- Who is Eligible?
- Frequently Asked Questions
- Conclusion
- Disclaimer
What is Scrambler Therapy?
Scrambler Therapy is a novel device-based approach aimed at altering pain signaling pathways in the nervous system. By mimicking non-pain signals, it may offer immediate relief for patients experiencing neuropathic pain without pharmacological interventions. In the context of CIPN, it represents a promising avenue for addressing symptoms like tingling, burning sensations, or loss of limb coordination. Its mechanism is grounded in neuroplasticity and the reconditioning of pain perception.
Study Design and Objectives
The upcoming trial employs a controlled design with two arms: Scrambler Therapy intervention and a sham/no intervention group. Researchers aim to evaluate the safety, effectiveness, and clinical outcomes of the device in alleviating neuropathic pain linked to chemotherapy. By comparing outcomes against a control, the study will adhere to rigorous scientific standards, ensuring validity and reliability in results.
Case Comprehensive Cancer Center and VelaSano are spearheading this effort, underscoring their commitment to advancing cancer care therapies. Results could offer key insights into potential regulatory applications and device approval processes moving forward.
Who is Eligible?
While recruitment has not yet started, eligibility criteria are expected to focus on cancer patients experiencing moderate to severe CIPN. Participants will likely need to meet specific chemotherapy treatment thresholds and demographic requirements. Researchers will ensure comprehensive screening to align with trial objectives and patient safety.
For oncology professionals, understanding these criteria is vital to educating eligible patients about opportunities for participation. Further announcements will detail recruitment timelines and finalized protocols.
Frequently Asked Questions
- What is CIPN?
CIPN refers to peripheral neuropathy caused by chemotherapy drugs. Symptoms include tingling, numbness, and chronic pain, primarily affecting the hands and feet. - What does Scrambler Therapy involve?
Scrambler Therapy uses electrical signals to disrupt chronic pain patterns by sending pain-free stimuli to affected nerve areas. - Can Scrambler Therapy replace medications?
While promising, the therapy is currently intended as a complement to medical pain management, pending further research outcomes. - When will the study start recruiting?
Recruitment has not yet started as of October 2023. Updated details are expected closer to the launch date.
Conclusion
This upcoming trial investigating Scrambler Therapy for CIPN signals advancements in therapeutic device innovation. Clinicians, quality teams, and regulatory professionals should monitor its developments for implications in oncology and pain management. With strong collaboration between Case Comprehensive Cancer Center and VelaSano, the study aims to provide evidence-based solutions that could transform care standards.
Disclaimer
This article is informational and tailored for clinical, quality, and regulatory audiences. It does not provide legal or medical device approval advice. For specific guidance, consult regulatory authorities or industry experts.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07219472?term=medical+device