Establishment of an Interdisciplinary Functional Neurological Disorder (FND) Treatment Program and Development of a Clinical Care Pathway for FND

NCT06362161 | Recruiting

• 1 other identifier: IRB-300011066
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to help providers develop an interdisciplinary treatment pathway for functional neurological disorder (FND) at University of Alabama at Birmingham (UAB), and will involve psychiatry, speech therapy, physical therapy, and occupational therapy. The study will also help providers to evaluate the treatment pathway and publish results regarding the process and outcomes.

Conditions

Functional Neurological Disorder; Convulsion, Non-Epileptic; Functional Seizure

Outcome Measures

Primary Outcomes (19)

• Patient Demographic Information

  Includes questions regarding patient's demographic information, referring physician, current symptoms, medical history, and recent functioning including work and school missed, mobility aids used, or receipt of disability service. Completed by adult FND patients and parent/guardian of pediatric FND patients during the intake therapy session before beginning treatment and after completing FND treatment.

  4 months

• Hospital Anxiety and Depression Scale (HADS)

  HADS is a self-assessment scale for detecting states of depression and anxiety in the setting of an outpatient hospital. Score ranges from 0-21 for depression and anxiety respectively and higher scores indicate greater anxiety and depression. Completed by adult patient before beginning treatment and after completing treatment.

  4 months

• ASM 121 functional assessment definitions

  Assesses activities of daily living. Scores ranges from 12-60; higher scores indicate greater difficulty in performing daily activities. Completed by adult patient before beginning treatment and after completing treatment.

  4 months

• SF-36 (subjective health and wellbeing)

  Assesses physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Completed by adult patient before beginning treatment and after completing treatment.

  4 months

• Work and Social Adjustment Scale (WSAS)

  Assesses impairment in functioning. Score ranges from 0-40; higher scores indicate severe functional impairment. Completed by adult patient before beginning treatment and after completing treatment.

  4 months

• Patient Health Questionnaire 15

  Assesses patient's physical symptom severity. Scores ranges from 0-30; higher scores indicate severe somatoform disorder. Completed by adult patient before beginning treatment and after completing treatment.

  4 months

• Dizziness Handicap Inventory

  Assesses functional, physical and emotional problems related to dizziness, specifically considering their condition in the last month. Scores range from 0-100; higher scores indicate severe handicap. Completed by adult FND patient and pediatric patients and their parent/guardian before beginning treatment and after completing treatment.

  4 months

• Dizziness Symptom Profile

  Assesses severity of dizziness. Score ranges from 0-124; higher scores indicate severe impairment due to dizziness. Completed by adult patient, and pediatric patient and their parent/guardian before beginning treatment and after completing treatment.

  4 months

• Adult Tic Questionnaire (ATQ)

  The ATQ is a brief self-report questionnaire that provides information regarding frequency, intensity, and severity of vocal and motor tics. Completed by adult patient before beginning treatment and after completing treatment.

  4 months

• Child Self-Report Tic Questionnaire

  The child self-report tic questionnaire is a brief self-report questionnaire that provides information regarding frequency, intensity, and severity of vocal and motor tics.Completed by pediatric patient before beginning treatment and after completing treatment.

  4 months

• Parent Tic Questionnaire (PTQ)

  The PTQ assesses tic severity, frequency and intensity in the past week, allowing for individual parent ratings of tic presence or absence for 14 vocal tics and 14 motor tics.Completed by parent/guardian of pediatric patients before beginning treatment and after completing treatment.

  4 months

• Seizure Questionnaire

  Assesses any functional seizure the patient is experiencing. Completed by adult FND patients, pediatric patients and their parent/guardian before beginning treatment and after completing FND treatment.

  4 months

• Level 2-Somatic Symptom report

  Measures symptom severity in children; scores ranges from 0-26, higher scores indicate greater symptom severity. Completed by pediatric patient and parent/guardian before beginning treatment and after completing treatment.

  4 months

• Revised Children's Anxiety and Depression Scale (RCADS)

  Measures anxiety and depression symptoms in children; total score ranges from 0-141, higher scores indicate increased symptom severity. Completed by pediatric patient and parent/guardian before beginning treatment and after completing treatment.

  4 months

• Functional Disability Inventory (FDI)

  Measures physical functioning and disability in children with chronic pain; score ranges from 0-60, higher scores indicate greater perceived functional disability. Completed by pediatric patient and parent/guardian before beginning treatment and after completing treatment.

  4 months

• Impact on the Family Scale

  Assesses parental perceptions of the impact of a child's medical condition on the family (assesses impact on financial burden, familial/social impact, personal strain and mastery); higher scores indicate greater financial burden on the family. Completed by pediatric patient and parent/guardian before beginning treatment and after completing treatment.

  4 months

• Pediatric Quality of Life (Peds-QL)

  Assesses quality of life, greater scores indicate greater quality of life. Scores range from 0-100. Completed by pediatric patient and parent/guardian before beginning treatment and after completing treatment.

  4 months

• Healthcare Utility Questionnaire

  Assesses patients visits to a physician's office or emergency room related to their FND symptoms. Completed by adult patient, and pediatric patient and their parent/guardian throughout the study.

  4 months

• Assessment of control over symptoms

  Single question that assesses the control patients have over their symptoms. Completed by adult patient, and pediatric patient and their parent/guardian before beginning treatment and after completing treatment.

  4 months

Eligibility Criteria

• Age: 8 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be referred to the interdisciplinary FND clinical pathway via UAB- or non-UAB clinicians and physicians. Individuals who are referred will be eligible to participate in the study.

You may qualify if:

• Diagnosis of FND
• Can read and write English fluently
• Referred to UAB outpatient treatment for FND in physical, occupational, or speech therapy
• Referred to UAB outpatient treatment for FND in psychiatry
• Referred to inpatient consult for FND at Children's of Alabama or UAB Hospital
• Parent/guardian willing to participate in the study with a pediatric patient

You may not qualify if:

• Unable to read or write English fluently

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Conversion Disorder; Seizures

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aaron Fobian, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Fobian, PhD

CONTACT

205-934-2241; afobian@uabmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: July 18, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

US (1)