Behavioral intervention for swallowing improvement after neck surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to recruit patients undergoing Anterior Cervical Discectomy and Fusion (ACDF) surgeries at NYU Langone Health. Participants will undergo swallowing assessments before and six weeks after surgery, alongside a behavioral health program that starts one week prior to surgery and continues for six weeks post-operation. The study will evaluate whether this proactive approach enhances swallowing and voice outcomes after the surgical procedure. Various assessments, including videofluoroscopy and patient-reported outcomes, will be utilized to measure effectiveness.

Why it matters

Who can join: the full rules

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.

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Sonja Molfenter, PhD — NYU Langone Health
• Study coordinator: Sonja Molfenter, PhD
• Email: Smm16@nyu.edu
• Phone: 212-992-7694

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.