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Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

Pilot Proof of Concept, Prospective Cohort, Single-Center Study on the Effects of Behavioral Intervention on Swallowing and Voice Outcomes After Anterior Cervical Discectomy and Fusion (ACDF) Surgery

Who can join

Ages 21 to 99 · All sexes

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 the study

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. .

What is being tested

• Proactive pharyngeal-laryngeal Exercise Program (behavioral)
• Premier Protein Clear ® High Protein (dietary supplement)
• Hydration Counseling (behavioral)

Sponsor: NYU Langone Health · Participants: 50 · Started: Oct 15, 2024

Contact the study team

• Sonja Molfenter, PhD · Phone: 212-992-7694

Official record on ClinicalTrials.gov — NCT06520579

Locations in the U.S.

Conditions

• Swallowing Disorders

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.