RecruitingNot ApplicableNCT06873698

Pilot Neurobehavioral Therapy for Functional Neurological Disorder

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


Sponsor

Rhode Island Hospital

Enrollment

40 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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 the investigator if they preclude participation in the study
  • Serious illness requiring systemic treatment or hospitalization; the participant either completes therapy or is clinically stable on therapy, for at least 30 days prior 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

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Interventions

BEHAVIORALNeuro-behavioral Therapy

Neuro-behavioral therapy (NBT) is an evidence-based, multi-modality, time-limited, whole-person therapy, delivered in one hour, weekly, individual appointments. NBT has been used to treat epilepsy, nonepileptic (functional) seizures, and motor functional neurological disorder (mFND).

OTHERStandard Medical Care (SMC)

Standard Medical Care (SMC) involves the routine care received by the participant. SMC may include any of the following evaluation and followup appointments with neurology, physiatry, psychiatry, psychology, mental health, rehabilitation (e.g., Physical Therapy, Occupational Therapy, Speech and Language Therapy), primary care, among other specialists.


Locations(1)

Rhode Island Hospital

Providence, Rhode Island, United States

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NCT06873698