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Search / Trial NCT06520579

Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

Launched by NYU LANGONE HEALTH · Jul 22, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how a special behavioral health program can help improve swallowing and voice after a specific surgery called Anterior Cervical Discectomy and Fusion (ACDF). Researchers at NYU Langone are looking for patients who are scheduled to have this surgery. Participants will be assessed for swallowing ability before their surgery and again six weeks afterward using a method that takes video images of their swallowing process. They will also provide voice samples and answer questions about their swallowing and voice quality. The main goal is to see if this behavioral health program, which starts a week before surgery and continues for six weeks afterward, can make a positive difference in how well patients swallow and speak after their surgery.

To be eligible for this study, patients need to be between 21 and 99 years old and be able to sign a consent form to participate. They must be scheduled for ACDF surgery at NYU Langone and should not have certain health conditions, like previous surgeries on their neck or specific medical issues that could affect their swallowing. Participants can expect to receive support through the behavioral health program, and their progress will be carefully monitored to see how it impacts their recovery after surgery. If you or someone you know might be interested in joining this study, it could be an opportunity to help improve outcomes for those undergoing ACDF surgery.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Able and willing to sign consent form to participate in the study.
  • 2. Age between 21- 99 years.
  • 3. Scheduled to undergo ACDF surgery with surgeons in the departments of Neurosurgery or Orthopedic Surgery at NYU Langone.
  • Exclusion Criteria:
  • 1. Patients with non-degenerative spine conditions, such as trauma, tumors, infection, radiation, and diabetes.
  • 2. Patients with prior posterior-approach cervical spine procedures.
  • 3. Patients undergoing ACDF revision procedures.
  • 4. Patients who report a pre-existing dysphagia as the result of a neurological deficit or disorder, head and neck cancer treatment, and/or muscular condition.
  • 5. Pregnancy. Female subjects must confirm they are not pregnant before enrolling in the study.
  • 6. Patients with chronic kidney disease, limiting their ability to consume high levels of protein.
  • 7. Patients with known allergies to ingredients listed in Premier Protein Clear drinks.

About Nyu Langone Health

NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Sonja Molfenter, PhD

Principal Investigator

NYU Langone Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported