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

NCT06873698 NA RECRUITING

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.

Details

Lead sponsor	Rhode Island Hospital
Phase	NA
Status	RECRUITING
Enrolment	40
Start date	2024-09-25
Completion	2028-06

Conditions

• Functional Neurological Disorder

Interventions

• Neuro-behavioral Therapy
• Standard Medical Care (SMC)

Primary outcomes

• SF-36 Health Survey (SF-36) — Baseline, Week 6, Week 12, 8 Months and 12 Months
  The SF-36 is a 36-item self-report measure that assess 8 domains: 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.
• Psychogenic Movement Disorders Rating Scale (PMDRS) — Baseline, Week 6, Week 12, 8 Months and 12 Months
  The PMDRS is a clinical assessment tool designed to measure the severity and characteristics of abnormal movements associated with psychogenic movement disorders (also called functional movement disorders), including details like the type of movement, affected body regions, duration, and functional impact of the symptoms, allowing clinicians to track changes over time and evaluate treatment efficacy.
• Simplified Functional Movement Disorders Rating Scale (S-FMDRS) — Baseline, Week 6, Week 12, 8 Months and 12 Months
  The S-FMDRS is a clinical tool used to assess the severity of functional movement disorders (FMDs) by evaluating the presence and intensity of abnormal movements in different body regions, including gait and speech.

Countries

United States