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Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

RecruitingNAAges 21 Years - 99 YearsAllNYU Langone Health
NCT06520579 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. .

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📋 Eligibility rules (as published)
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.
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What it tests

  • Proactive pharyngeal-laryngeal Exercise Program
  • Premier Protein Clear ® High Protein
  • Hydration Counseling
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Where

1 site
NYU Langone Health
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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