Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention
Recruiting now · Not applicable
Conditions studied: Dysphagia
In brief
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. .
Key facts
- Study ID
- NCT06520579
- Run by
- NYU Langone Health
- People needed
- 50
- Starts
- 2024-10-15
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-02-27
Who can join
Age: 21 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Able and willing to sign consent form to participate in the study.
- Age between 21- 99 years.
- Scheduled to undergo ACDF surgery with surgeons in the departments of Neurosurgery or Orthopedic Surgery at NYU Langone.
You may not qualify if…
- 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.
Where it is running
- NYU Langone Health — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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