Actively Recruiting

Phase Not Applicable
Age: 21Years - 99Years
All Genders
NCT06520579

Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

Led by NYU Langone Health · Updated on 2026-02-27

50

Participants Needed

1

Research Sites

98 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will prospectively recruit and enroll patients undergoing primary Anterior Cervical Discectomy and Fusion (ACDF) surgeries at NYU Langone. Participants will undergo pre-operative and six-week post-operative swallowing assessment using videofluoroscopy (VFSS). Acoustic voice samples and Patient Reported Outcome Measures (PROMs) for swallowing and voice will also be collected. Beginning one-week before surgery participants will begin a behavioral health program that will be continued for six-weeks after surgery. The primary goal of this study will be to determine whether a preventative behavioral health program improves instrumental measures of swallowing and voice six-weeks after ACDF surgery. .

CONDITIONS

Official Title

Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

Who Can Participate

Age: 21Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to sign consent form to participate in the study.
  • Age between 21 and 99 years.
  • Scheduled to undergo ACDF surgery with surgeons in the departments of Neurosurgery or Orthopedic Surgery at NYU Langone.
Not Eligible

You will not qualify if you...

  • Patients with non-degenerative spine conditions, such as trauma, tumors, infection, radiation, and diabetes.
  • Patients with prior posterior-approach cervical spine procedures.
  • Patients undergoing ACDF revision procedures.
  • 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.
  • Pregnancy. Female subjects must confirm they are not pregnant before enrolling in the study.
  • Patients with chronic kidney disease, limiting their ability to consume high levels of protein.
  • Patients with known allergies to ingredients listed in Premier Protein Clear drinks.

AI-Screening

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Trial Site Locations

Total: 1 location

1

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

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Research Team

S

Sonja Molfenter, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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