Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

Description

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

Dysphagia

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Study Overview

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Study Details

Study overview

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. .

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

Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

Condition
Dysphagia
Intervention / Treatment

-

Contacts and Locations

New York

NYU Langone Health, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

21 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Sonja Molfenter, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

2025-09-01