Transcutaneous Auricular Vagus Nerve Stimulation in Upper Extremity Lymphedema
Launched by SEDA SAKA · Sep 29, 2023
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new method called transcutaneous auricular vagus nerve stimulation, which could help improve the quality of life for people with lymphedema in their arms. Lymphedema is a condition where fluid builds up in the tissues, causing swelling and discomfort. This trial aims to see if stimulating the vagus nerve (a nerve that helps control many body functions) alongside standard treatments can enhance grip strength and hand function in patients.
To participate, individuals must be between 18 and 65 years old and have been diagnosed with secondary lymphedema at least three months after surgery. They must also have moderate to severe lymphedema (stages 2 or 3). Participants will be randomly assigned to one of three groups: one group will receive standard treatment, another will receive standard treatment plus a fake stimulation, and the last group will receive both standard treatment and the actual nerve stimulation. This study will take place at Gaziosmanpaşa Physical Therapy Rehabilitation Training and Research Hospital, and all data will be carefully analyzed to determine the effects of the treatments.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Between the ages of 18-65
- • Diagnosed with secondary lymphedema disease by the physician
- • Minimum of three months after surgery
- • Stage 2 and 3 patients
- • Native speaker Turkish
- • Individuals who agreed to participate in the study
- Exclusion Criteria:
- • Individuals with any neurological or orthopedic problems in the upper extremity
- • Individuals undergoing upper extremity surgery
- • Presence of cardiac edema
- • Presence of arterial disease
- • Presence of acute venous disease
- • Those with sensory impairment
- • Those with cardiac rhythm disorders
- • Individuals with cooperation problems
About Seda Saka
Seda Saka is a clinical trial sponsor dedicated to advancing innovative healthcare solutions through rigorous research and development. With a focus on improving patient outcomes, Seda Saka collaborates with leading medical professionals and institutions to conduct high-quality clinical trials across various therapeutic areas. The organization is committed to adhering to the highest ethical standards and regulatory compliance, ensuring that all studies are designed with patient safety and scientific integrity as top priorities. By fostering partnerships and leveraging cutting-edge technology, Seda Saka aims to accelerate the development of transformative therapies that meet the evolving needs of the healthcare landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Kevser Gümüşsu, MD
Study Director
Gaziosmanpaşa Eğitim ve Araştırma Hastanesi
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported