Clinician-rated outcomes of patients with functional neurological disorders treated in an outpatient clinic.
W Curt LaFrance, Roberta Tedesco, Grayson L Baird...
https://pubmed.ncbi.nlm.nih.gov/36933399Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06873698
A Pilot Randomized Controlled Trial of Neurobehavioral Therapy vs Standard Medical Care for Functional Neurological Disorder
Led by Rhode Island Hospital · Updated on 2025-04-01
40
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Neurobehavioral Therapy (NBT) to see if it helps treat motor functional neurological disorder (mFND), a condition also called functional motor disorder. This pilot randomized clinical trial aims to find out if NBT can reduce mFND symptoms, improve common co-occurring symptoms, and enhance overall functioning compared to standard medical care (SMC). Participants will be randomly assigned to one of two groups. One group will receive 12 weekly individual sessions of NBT, delivered virtually over 12 to 18 weeks, using a structured workbook with pre-session worksheets. The other group will continue with their usual standard medical care provided by their clinicians without the additional therapy. All participants will attend five in-person clinic visits at baseline, 6 weeks, 12 weeks, 8 months, and 12 months. During these visits, participants will complete interviews and self-report surveys assessing functional status, quality of life, and mFND symptoms. Researchers will measure outcomes using tools like the SF-36 Health Survey and movement disorder rating scales at multiple time points. The study also includes monitoring anxiety, depression, trauma symptoms, cognitive function, and overall health. The total study duration for participants is 12 months, with ongoing assessments to track changes over time.
CONDITIONS
Brief Title
Pilot Neurobehavioral Therapy for Functional Neurological Disorder
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Individuals diagnosed with Motor Functional Neurological Disorder (mFND)
- Individuals aged 18-70 years
- At least 1 mFND symptom during the year prior to enrollment
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 to 18 weeks
Participants randomized to Neuro-behavioral Therapy will complete weekly one-hour individual therapy sessions over 12 to 18 weeks. Participants randomized to Standard Medical Care will continue their routine care with their clinicians without study intervention.
Weekly therapy sessions for Neuro-behavioral Therapy participants; Standard Medical Care participants continue routine care
Outpatient Treatment
Duration - 12 months
All participants will attend in-person clinic visits to complete interviews and self-report surveys assessing functional status, quality of life, and symptoms at multiple time points throughout the study.
5 in-person clinic visits at Baseline, 6 weeks, 12 weeks, 8 months, and 12 months
Trial Site Locations
Total: 1 location
1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
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Research Team
A
Alexis Sr. Clinical Research Assistant
D
Deepica Clinical Research Program Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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