RECRUITING

Pilot Neurobehavioral Therapy for Functional Neurological Disorder

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

The goal of this pilot randomized clinical trial is to learn if Neurobehavioral Therapy (NBT) works to treat motor functional neurological disorder (mFND) (also referred to as functional motor disorder). The main questions it aims to answer are: * Does NBT lower mFND symptoms? * Does NBT lower common co-occurring symptoms and improve functioning? Researchers will compare NBT to standard medical care (SMC). Participants will be randomized to receive either: * 12 weekly sessions of NBT, along with their SMC, * or continue receiving their SMC as provided by their treating clinicians. * all participants. regardless of group assignment, will complete a total of five in-clinic visits at the following time points: Baseline, 6 weeks, 12 weeks, 8 Months and 12 Months for self-report surveys to assess functional status, quality of life and mFND symptoms.

Official Title

A Pilot Randomized Controlled Trial (RCT) of Neurobehavioral Therapy (NBT) Vs Standard Medical Care (SMC) for Functional Neurological Disorder (FND)

Quick Facts

Study Start:2024-09-25
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06873698

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:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals diagnosed with Motor Functional Neurological Disorder (mFND)
  2. * Individuals aged 18-70 years
  3. * At least 1 mFND symptom during the year prior to enrollment
  1. * Current or past year self-injurious behavior
  2. * Current suicidality (PHQ-9 question 9 rated as 1 or above)
  3. * Current or past year psychosis
  4. * Pending litigation or current application for long term disability
  5. * Active substance or alcohol use disorders (dependence), at the discretion of the investigator if they preclude participation in the study
  6. * Serious illness requiring systemic treatment or hospitalization; the participant either completes therapy or is clinically stable on therapy, for at least 30 days prior to study entry
  7. * Inability to fill out the self-report surveys
  8. * Inability or unwillingness to participate in NBT and assigned homework
  9. * Currently enrolled in NBT aimed at mFND

Contacts and Locations

Study Contact

Alexis Sr. Clinical Research Assistant
CONTACT
401-606-4651
ademarco@brownhealth.org
Deepica Clinical Research Program Coordinator
CONTACT
401-606-4655
dchaudhary@brownhealth.org

Principal Investigator

W. Curt LaFrance Jr, MD, MPH
PRINCIPAL_INVESTIGATOR
Brown University Health
Emily Weisbach, MD
STUDY_CHAIR
Brown University Health

Study Locations (Sites)

Rhode Island Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Rhode Island Hospital

  • W. Curt LaFrance Jr, MD, MPH, PRINCIPAL_INVESTIGATOR, Brown University Health
  • Emily Weisbach, MD, STUDY_CHAIR, Brown University 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 Date2024-09-25
Study Completion Date2028-06

Study Record Updates

Study Start Date2024-09-25
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • mFND
  • Conversion Disorder
  • Functional Neurologic Disorder
  • Neurobehavioral Therapy
  • FND
  • Psychogenic Movement Disorder
  • Psychotherapy
  • motor functional neurological disorder
  • functional motor disorder

Additional Relevant MeSH Terms

  • Functional Neurological Disorder