Pilot Neurobehavioral Therapy for Functional Neurological Disorder

Last updated: March 26, 2025
Sponsor: Rhode Island Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypochondriasis

Neurologic Disorders

Anxiety Disorders

Treatment

Neuro-behavioral Therapy

Standard Medical Care (SMC)

Clinical Study ID

NCT06873698
2136841
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals diagnosed with Motor Functional Neurological Disorder (mFND)

  • Individuals aged 18-70 years

  • At least 1 mFND symptom during the year prior to enrollment

Exclusion

Exclusion Criteria:

  • Current or past year self-injurious behavior

  • Current suicidality (PHQ-9 question 9 rated as 1 or above)

  • Current or past year psychosis

  • Pending litigation or current application for long term disability

  • Active substance or alcohol use disorders (dependence), at the discretion of theinvestigator if they preclude participation in the study

  • Serious illness requiring systemic treatment or hospitalization; the participanteither completes therapy or is clinically stable on therapy, for at least 30 daysprior to study entry

  • Inability to fill out the self-report surveys

  • Inability or unwillingness to participate in NBT and assigned homework

  • Currently enrolled in NBT aimed at mFND

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Neuro-behavioral Therapy
Phase:
Study Start date:
September 25, 2024
Estimated Completion Date:
June 30, 2028

Study Description

The study aims to enroll 40 participants at Rhode Island Hospital. 20 participants with Motor Functional Neurological Disorder (mFND) will be randomized to Neurobehavioral Therapy (Group 1) and 20 participants with mFND to Standard Medical Care (Group 2). Those randomized to neurobehavioral therapy will be asked to complete treatment sessions over the course of 12 to 18 weeks. Those in the standard medical care arm will continue to receive their routine care with their clinicians.

All participants regardless of group assignment, will complete a total of five in-person clinic visits at the following time points: Baseline, 6 weeks, 12 weeks, 8 Months and 12 Months. These visits will include the completion of interview questions and self-report surveys that will assess functional status, quality of life and mFND symptoms.

Please see the "Arms and Interventions" section to see a more detailed description of each group/arm.

The goal of this Clinical Trial is to investigate the feasibility and efficacy of Neuro-Behavioral Therapy in Individuals aged 18 to 70 diagnosed with Motor Functional Neurologic Disorder. The main questions this study aims to answer are:

Aim 1: Examine the feasibility, acceptability, and practicality of manualized Neuro-Behavioral Therapy (NBT) in Functional Neurological Disorder (FND).

Hypothesis 1: Manualized NBT will demonstrate feasibility through acceptability and practicality, defined as ≥80% of participants enrolling in the study will participate in the study measures (acceptability) and complete the entire study protocol (practicality), respectively.

Aim 2: Examine the preliminary effectiveness of manualized NBT in improving health-related quality of life and reducing the severity and disability of mFNDs, as measured by the SF-36 and PMDRS/S-FMDRS (primary outcome), respectively.

Hypothesis 2: NBT will show improvements in SF-36 scores and reductions in PMDRS scores. We will evaluate this by conducting a preliminary examination of the manualized NBT intervention, with a focus on interpreting effect sizes. We will also gather key statistics needed to inform a fully powered clinical trial, such as the standard deviation and pre-post correlation of the SF-36 and PMDRS.

Connect with a study center

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

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