Pilot Neurobehavioral Therapy for Functional Neurological Disorder

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Rhode Island Hospital
Study ID
NCT06873698
Status
Recruiting
Apply to this trial

Conditions

  • Functional Neurological Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Neuro-behavioral Therapy — BEHAVIORAL
    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).
  • Standard Medical Care (SMC) — OTHER
    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.

Study Details

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.

Key Dates

Start date
Sep 25, 2024
Status verified
Mar 2025
Primary completion
Jan 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neuro-Behavioral Therapy
    Participants will receive neuro-behavioral therapy (NBT), in individual, weekly, one-hour appointments, using the 12 session, "Taking Control of Your Functional Movements: Workbook", over the course of 12 to 18 weeks. Before each appointment, participants will complete worksheets/questions in one chapter that will be discussed during the weekly virtual appointment. Video appointments will be completed using an encrypted healthcare weblink and will be digitally recorded for review to ensure therapy adherence and competence. Participants randomized to the NBT arm will also participate in 5 in-person visits for exam documentation.
  • Active Comparator: Standard Medical Care
    If randomized to this treatment arm, participants will continue to follow up with their clinicians while receiving standard medical care (SMC) and without receiving the study intervention. Research staff will ask about what care participants are receiving when they meet with staff. Subjects randomized to the SMC arm will participate in 5 in-person visits for exam and SMC documentation.

Primary Outcome Measure

SF-36 Health Survey (SF-36) [ Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island HospitalProvidenceRhode Island02903-

Find similar trials in Providence, RI

By research site
Rhode Island Hospital· Providence, RI

Related Studies