Pilot Neurobehavioral Therapy for Functional Neurological Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorRhode Island Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Individuals diagnosed with Motor Functional Neurological Disorder (mFND)

Individuals aged 18-100 years

At least 1 mFND symptom during the year prior to enrollment

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Neuro-Behavioral TherapyExperimental treatment 1 intervention
Group B: Standard Medical CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

SF-36 Health Survey (SF-36)

The SF-36 is a 36-item self-report measure that assess 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.

Time frame
Baseline, Week 6, Week 12, 8 Months and 12 Months
2

Psychogenic Movement Disorders Rating Scale (PMDRS)

The PMDRS is a clinical assessment tool designed to measure the severity and characteristics of abnormal movements associated with psychogenic movement disorders (also called functional movement disorders), including details like the type of movement, affected body regions, duration, and functional impact of the symptoms, allowing clinicians to track changes over time and evaluate treatment efficacy.

Time frame
Baseline, Week 6, Week 12, 8 Months and 12 Months
3

Simplified Functional Movement Disorders Rating Scale (S-FMDRS)

The S-FMDRS is a clinical tool used to assess the severity of functional movement disorders (FMDs) by evaluating the presence and intensity of abnormal movements in different body regions, including gait and speech.

Time frame
Baseline, Week 6, Week 12, 8 Months and 12 Months

Secondary outcomes

1

Generalized Anxiety Disorder (GAD-7)

The GAD-7 is a 7 item self-report measure that assesses Anxiety severity from "0" (not at all) to "3" (nearly every day) on each question. The highest possible score is "21", relating to the highest severity of Generalized Anxiety Disorder.

Time frame
Baseline, Week 6, Week 12, 8 Months and 12 Months
2

Patient Health Questionnaire (PHQ-9)

The PHQ-9 is a 9-item self-report measure instrument that assesses the severity of Depression on a scale from "0" (not at all) to "3" (nearly every day). The maximum score is 27.

Time frame
Baseline, Week 6, Week 12, 8 Months and 12 Months
3

Patient Health Questionnaire (PHQ-15)

The PHQ-15 is a 15-item self-report measure instrument that assesses the presence and severity of somatic symptoms on a scale from "0" (not bothered at all) to "2" (bothered a lot). The maximum score is 30.

Time frame
Baseline, Week 6, Week 12, 8 Months and 12 Months
4

Posttraumatic Scale Checklist-5 (PCL-5)

The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms.

Time frame
Baseline, Week 6, Week 12, 8 Months and 12 Months

Other outcomes

1

Abnormal Movement Log

The Abnormal Movements Log is a daily diary to track unusual movements over the course of a week. Each day, individuals will record a series of details in relation to their mFND such as the number, duration, time, body parts affected, type of movement, severity (mild, moderate, severe), triggers, warning signs, what helps, and how it impacts themselves and others. The Principal Investigator will review the movement logs during study visits to better understand ones symptoms and how impactful they are one ones day. It's a simple tool aimed to identify patterns and improve care.

Time frame
Baseline, [Weekly - NBT Arm Only], Week 6, Week 12, 8 Months and 12 Months
2

Status Survey

The Status Survey is a 17 item self report measure that assesses research participants experience with motor Functional Neurological Disorder (FND) through the duration of the trial. The survey asks about current symptoms, emergency room visits, medications (for movement, anxiety, or depression), new therapies, and any new or worsening symptoms. It also includes questions about individuals daily life, such as work, disability status, driving, and overall quality of life over the past four weeks. The goal is to gather updates on how individuals are managing FND and its impact on ones well-being.

Time frame
Baseline, Week 6, Week 12, 8 Months and 12 Months

Sponsors and contacts

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