Neurobehavioral Therapy for Conversion Disorder

(NBT for mFND Trial)

Overseen By Deepica Clinical Research Program Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Disqualifiers: Self-injury, Suicidality, Psychosis, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 12-18 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Neurobehavioral Therapy (NBT) to determine its effectiveness for individuals with motor functional neurological disorder (mFND), a condition affecting movement without an obvious physical cause. Researchers aim to discover if NBT can reduce symptoms and enhance daily functioning compared to standard medical care. Participants will either receive 12 weekly sessions of NBT alongside their usual care or continue with their usual care alone. Individuals diagnosed with mFND who have experienced symptoms in the past year may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve future treatments for mFND.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. Participants will continue their standard medical care, so it's likely you can keep taking your current meds.

What prior data suggests that Neurobehavioral Therapy is safe for treating motor functional neurological disorder?

Research has shown that Neurobehavioral Therapy (NBT) is generally safe for treating functional neurological disorders. In previous studies, patients who received this therapy experienced better results without major safety issues. Although these studies focused on clinical outcomes, they did not report significant harmful side effects. This indicates that patients usually tolerate NBT well. However, consulting a healthcare professional is essential to understand what this means personally. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about neurobehavioral therapy for conversion disorder because it offers a new approach that integrates psychological and physical treatment. Unlike standard medical care that primarily focuses on managing symptoms, this therapy empowers patients by using a structured workbook to help them regain control over their movements. The therapy is delivered through weekly virtual sessions complemented by in-person visits, providing a flexible and comprehensive support system. This innovative method aims not only to treat symptoms but also to address the underlying behavioral aspects of conversion disorder, potentially leading to more effective and lasting results.

What evidence suggests that Neurobehavioral Therapy might be an effective treatment for motor functional neurological disorder?

Neurobehavioral Therapy (NBT), which participants in this trial may receive, has shown promise in treating functional neurological disorders. For instance, one study found that therapy reduced seizures in most patients. Another study demonstrated that a structured therapy approach improved outcomes for patients with motor functional neurological disorder (mFND). Additionally, an outpatient therapy program reduced anxiety, depression, and daily challenges in patients with similar conditions. These findings suggest that NBT may alleviate symptoms of mFND and enhance overall well-being. ^{1 2 6 7 8}

Who Is on the Research Team?

W. Curt LaFrance Jr, MD, MPH

Principal Investigator

Brown University Health

Emily Weisbach, MD

Principal Investigator

Brown University Health

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 to 70 with Motor Functional Neurological Disorder (mFND), which includes symptoms like panic attacks and conversion disorder. Participants should be able to attend treatment sessions over several weeks and commit to five in-person clinic visits for assessments.

Inclusion Criteria

I have been diagnosed with Motor Functional Neurological Disorder.

I have experienced at least one symptom of functional neurological disorder in the last year.

Exclusion Criteria

I've been stable for 30 days after treatment for a serious illness.

Current or past year self-injurious behavior

Current suicidality (PHQ-9 question 9 rated as 1 or above)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Neurobehavioral Therapy or Standard Medical Care. Neurobehavioral Therapy involves weekly one-hour sessions over 12 to 18 weeks, while Standard Medical Care involves routine care with clinicians.

12-18 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at Baseline, 6 weeks, 12 weeks, 8 months, and 12 months.

12 months

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Neuro-behavioral Therapy

Trial Overview The study compares Neurobehavioral Therapy (NBT) against Standard Medical Care (SMC) in patients with mFND. It aims to determine if NBT can improve quality of life and reduce symptom severity, measured by SF-36 and PMDRS/S-FMDRS scales, through regular sessions over 12-18 weeks.

How Is the Trial Designed?

Group I: Neuro-Behavioral Therapy Experimental Treatment 1 Intervention

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.

Group II: Standard Medical Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12506205/

Treatment outcomes in functional neurological disorder Seven out of eight studies found seizure frequency reductions following psychotherapy in cohorts with average symptom durations of 3–10 years.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06873698

Pilot Neurobehavioral Therapy for Functional Neurological ... The goal of this Clinical Trial is to investigate the feasibility and efficacy of Neuro-Behavioral Therapy in Individuals aged 18 to 70 diagnosed with Motor ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1059131123000651

Clinician-rated outcomes of patients with functional ... This study reveals improved clinician-rated patient clinical outcomes in motor FND and in FND seizures using manualized therapy.

4. link.springer.com link.springer.com/article/10.1007/s00415-023-12111-4

Routine outcomes and evaluation of an 8-week outpatient ... This outpatient therapy program provided effective treatment for FND. Patients reported reduced anxiety, depression, and functional impairment.

5. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2017.17040450

Treatment for Patients With a Functional Neurological ... Disability in functional neurological disorders is like that of structural disease, and neurological outcome at 8 months is poor, with over 50% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7293766/

Current Concepts in Diagnosis and Treatment of Functional ... Functional neurological disorders are common and disabling but potentially reversible. A positive or inclusionary diagnosis can be made with a high level of ...

7. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1288828/full

Optimizing outcomes when treating functional neurological ... Overall, patients with functional neurological disorder (FND) report decreased quality of life, similar to that of other neurological disorders.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36933399/

Clinician-rated outcomes of patients with functional ... We aimed to examine clinical outcomes in outpatients with FND treated with the Neuro-Behavioral Therapy (NBT) approach.