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Pilot Neurobehavioral Therapy for Functional Neurological Disorder

NCT06873698 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-01

No results posted yet for this 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.

Conditions

  • Functional Neurological Disorder

Interventions

BEHAVIORAL

Neuro-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).

OTHER

Standard 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.

Sponsors & Collaborators

  • Rhode Island Hospital

    lead OTHER

Principal Investigators

  • W. Curt LaFrance Jr, MD, MPH · Brown University Health

  • Emily Weisbach, MD · Brown University Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-25
Primary Completion
2028-01-31
Completion
2028-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06873698 on ClinicalTrials.gov