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RecruitingNCT06362161Updated Jun 11, 2026

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

An observational study in Functional Neurological Disorder, Convulsion, Non-Epileptic and Functional Seizure, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 8 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by University of Alabama at Birmingham · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,100
Ages
8 Years to 89 Years
Sex
All
01

Study 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.

Read the detailed description

Prospective Study: Adult patients, and pediatric patients and their parent/guardian who are referred to the UAB functional neurological disorder (FND) clinical pathway will be screened for eligibility. Overall 750 participants (250 adult patients, 250 pediatric patients and their parent/guardian) will be enrolled in the prospective study.

For patients for whom an FND inpatient consult has been requested, the consulting psychologist will screen eligible participants. For outpatient FND patients, the psychiatry FND clinic scheduling coordinator will screen patients for eligibility. Potential eligible participants will provide verbal consent during the screening phone call.

Once verbal consent has been obtained, participants will be given the pre-treatment survey questions (via email for outpatient referrals, via a tablet computer for inpatient consults). These surveys will be different for adult FND patients, children with FND, and parents/guardians of children with FND; each survey will contain the appropriate consent/assent form. Participants will complete the pre-treatment surveys once they sign the appropriate consent/assent form.

During each outpatient visit with a clinician, patients will be administered the one-item Clinical Global Improvement Scale and asked about retrospective symptom frequency, which will be entered directly into the electronic health record (EHR). If patients are seeing physical, occupational, or speech therapy (PT/OT/Speech), the clinician will enter clinical measures directly into the EHR. Following the course of FND treatment, participants and parents/guardians (where applicable) will complete the post-survey questionnaires.

Participants may be asked to provide full facial pictures and/or videos before treatment and after treatment.

Retrospective study: EHR data of participants who recieved FND treatment at UAB FND clinical pathway from Jan 2020 to May 2023 will be collected retrospectively. 500 records will be screened for potential inclusion in the study. Overall, data will be extracted from 350 patient records.

The research team will utilize EHR entries to pull any clinical data related to FND treatment visits (inpatient consults, outpatient psychiatry/PT/OT/Speech). This EHR data collection will be both retrospective and prospective, and include all records related to FND treatment, including neurology, PT/OT/Speech, and psychiatry notes.

The cost of participant's standard medical care will be billed to them and/or their insurance company in the usual manner. Participants will not be paid for participation in the study.

02

Conditions studied

  • Functional Neurological Disorder
  • Convulsion, Non-Epileptic
  • Functional Seizure
03

In context

Conversion Disorder

89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.

This study's planned enrollment of 1,100 is above the median of 60 across 37 observational studies indexed under Conversion Disorder.

Browse Conversion Disorder studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Unable to read or write English fluently
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,100 participants (estimated)
Target follow-up
4 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 months

  2. 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.

    Time frame: 4 months

  3. 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.

    Time frame: 4 months

  4. 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.

    Time frame: 4 months

  5. 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.

    Time frame: 4 months

  6. 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.

    Time frame: 4 months

  7. 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.

    Time frame: 4 months

  8. 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.

    Time frame: 4 months

  9. 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.

    Time frame: 4 months

  10. 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.

    Time frame: 4 months

  11. 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.

    Time frame: 4 months

  12. 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.

    Time frame: 4 months

  13. 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.

    Time frame: 4 months

  14. 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.

    Time frame: 4 months

  15. 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.

    Time frame: 4 months

  16. 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.

    Time frame: 4 months

  17. 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.

    Time frame: 4 months

  18. 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.

    Time frame: 4 months

  19. 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.

    Time frame: 4 months

07

Study locations

1 of 1 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
    Recruiting
    • Michelle Bumpers · Contact205-966-6425
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06362161
Responsible party
Aaron Fobian (Associate Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Apr 12, 2024
Start date
Jul 18, 2025
Primary completion
May 1, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jun 11, 2026

Study contacts

Aaron Fobian, PhD
Contact
afobian@uabmc.edu
205-934-2241
Aaron Fobian, PhD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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