RECRUITING

Anterior Cervical Discectomy and Fusion (ACDF) - Behavioral Intervention

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Conditions

Dysphagia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. .

Official Title

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

Quick Facts

Study Start:2024-10-15
Study Completion:2025-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06520579

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.

Ages Eligible for Study:21 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able and willing to sign consent form to participate in the study.
  2. 2. Age between 21- 99 years.
  3. 3. Scheduled to undergo ACDF surgery with surgeons in the departments of Neurosurgery or Orthopedic Surgery at NYU Langone.
  1. 1. Patients with non-degenerative spine conditions, such as trauma, tumors, infection, radiation, and diabetes.
  2. 2. Patients with prior posterior-approach cervical spine procedures.
  3. 3. Patients undergoing ACDF revision procedures.
  4. 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. 5. Pregnancy. Female subjects must confirm they are not pregnant before enrolling in the study.
  6. 6. Patients with chronic kidney disease, limiting their ability to consume high levels of protein.
  7. 7. Patients with known allergies to ingredients listed in Premier Protein Clear drinks.

Contacts and Locations

Study Contact

Sonja Molfenter, PhD
CONTACT
212-992-7694
Smm16@nyu.edu

Principal Investigator

Sonja Molfenter, PhD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Sonja Molfenter, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-15
Study Completion Date2025-09-01

Study Record Updates

Study Start Date2024-10-15
Study Completion Date2025-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Dysphagia