Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT06362161

Conditions

Functional Neurological Disorder

Convulsion, Non-Epileptic

Functional Seizure

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06362161

Start date

Jul 18, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

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:

  • Unable to read or write English fluently

Study Design

Enrollment

1100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Patient Demographic Information [ Time Frame: 4 months ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 4 months ]
  • ASM 121 functional assessment definitions [ Time Frame: 4 months ]
  • SF-36 (subjective health and wellbeing) [ Time Frame: 4 months ]
  • Work and Social Adjustment Scale (WSAS) [ Time Frame: 4 months ]
  • Patient Health Questionnaire 15 [ Time Frame: 4 months ]
  • Dizziness Handicap Inventory [ Time Frame: 4 months ]
  • Dizziness Symptom Profile [ Time Frame: 4 months ]
  • Adult Tic Questionnaire (ATQ) [ Time Frame: 4 months ]
  • Child Self-Report Tic Questionnaire [ Time Frame: 4 months ]
  • Parent Tic Questionnaire (PTQ) [ Time Frame: 4 months ]
  • Seizure Questionnaire [ Time Frame: 4 months ]
  • Level 2-Somatic Symptom report [ Time Frame: 4 months ]
  • Revised Children's Anxiety and Depression Scale (RCADS) [ Time Frame: 4 months ]
  • Functional Disability Inventory (FDI) [ Time Frame: 4 months ]
  • Impact on the Family Scale [ Time Frame: 4 months ]
  • Pediatric Quality of Life (Peds-QL) [ Time Frame: 4 months ]
  • Healthcare Utility Questionnaire [ Time Frame: 4 months ]
  • Assessment of control over symptoms [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Michelle Bumpers

205-966-6425

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-11.