Neurobehavioral Therapy for treating Functional Neurological Disorder
A Pilot Randomized Controlled Trial (RCT) of Neurobehavioral Therapy (NBT) Vs Standard Medical Care (SMC) for Functional Neurological Disorder (FND)
This study is testing whether Neurobehavioral Therapy can help adults with motor functional neurological disorder feel better when combined with regular medical care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Rhode Island Hospital Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06873698 on ClinicalTrials.gov |
What this trial studies
This pilot randomized clinical trial aims to evaluate the effectiveness of Neurobehavioral Therapy (NBT) in treating motor functional neurological disorder (mFND). Participants will be randomly assigned to receive either 12 weekly sessions of NBT alongside standard medical care or continue with standard medical care alone. The study will assess the impact of NBT on mFND symptoms and co-occurring issues through self-report surveys and in-clinic visits over a 12-month period. A total of 40 participants aged 18 to 70 will be enrolled at Rhode Island Hospital.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 70 diagnosed with motor functional neurological disorder who have experienced at least one symptom in the past year.
Not a fit: Patients with current suicidality, serious mental health issues, or those currently enrolled in similar therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce symptoms of mFND and improve overall functioning for patients.
How similar studies have performed: While this approach is novel, similar interventions have shown promise in treating functional neurological disorders, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals diagnosed with Motor Functional Neurological Disorder (mFND) * Individuals aged 18-70 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
Where this trial is running
Providence, Rhode Island
- Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: W. Curt LaFrance Jr, MD, MPH — Brown University Health
- Study coordinator: Alexis Sr. Clinical Research Assistant
- Email: ademarco@brownhealth.org
- Phone: 401-606-4651
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.