NCT06520579 Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention
| NCT ID | NCT06520579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Dysphagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-10-15 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-10-15 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. .
Eligibility Criteria
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.
Contact & Investigator
Sonja Molfenter, PhD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06520579 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 99 Years, studying Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06520579 currently recruiting?
Yes, NCT06520579 is actively recruiting participants. Contact the research team at Smm16@nyu.edu for enrollment information.
Where is the NCT06520579 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06520579 clinical trial?
NCT06520579 is sponsored by NYU Langone Health. The principal investigator is Sonja Molfenter, PhD at NYU Langone Health. The trial plans to enroll 50 participants.