Recruiting

Neurobehavioral Therapy

Sponsor:

Rhode Island Hospital

Code:

NCT06873698

Conditions

Functional Neurological Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Neuro-behavioral Therapy

Standard Medical Care (SMC)

Study Details

Brief 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

Study ID

NCT06873698

Start date

Sep 25, 2024

Status verified date

Jul, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Individuals diagnosed with Motor Functional Neurological Disorder (mFND)
  • Individuals aged 18-100 years
  • At least 1 mFND symptom during the year prior to enrollment

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 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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).

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.

Primary outcome measure

  • SF-36 Health Survey (SF-36) [ Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months ]
  • Psychogenic Movement Disorders Rating Scale (PMDRS) [ Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months ]
  • Simplified Functional Movement Disorders Rating Scale (S-FMDRS) [ Time Frame: Baseline, Week 6, Week 12, 8 Months and 12 Months ]

Central Contacts and Locations

Central contacts

Alexis Sr. Clinical Research Assistant

401-606-4651ademarco@brownhealth.org

Deepica Clinical Research Program Coordinator

401-606-4655dchaudhary@brownhealth.org

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

More Information

Sponsor

Rhode Island Hospital

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • mFND
  • Conversion Disorder
  • Functional Neurologic Disorder
  • Neurobehavioral Therapy
  • FND
  • Psychogenic Movement Disorder
  • Psychotherapy
  • motor functional neurological disorder
  • functional motor disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2026-07-09.