Functional Neurological DisorderNBT for mFNDNCT06873698
Pilot Neurobehavioral Therapy for Functional Neurological Disorder
A study testing Neuro-behavioral Therapy and Standard Medical Care (SMC) in people with Functional Neurological Disorder, run by Rhode Island Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Functional Neurological Disorder
- What is being tested?
- Neuro-behavioral Therapy and Standard Medical Care (SMC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with Motor Functional Neurological Disorder (mFND)
- Individuals aged 18-100 years
- At least 1 mFND symptom during the year prior to enrollment
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: A Pilot Randomized Controlled Trial (RCT) of Neurobehavioral Therapy (NBT) vs Standard Medical Care (SMC) for Functional Neurological Disorder (FND)
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:
Read more
- 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.
Read the detailed description
The study aims to enroll 40 participants at Rhode Island Hospital. 20 participants with Motor Functional Neurological Disorder (mFND) will be randomized to Neurobehavioral Therapy (Group 1) and 20 participants with mFND to Standard Medical Care (Group 2). Those randomized to neurobehavioral therapy will be asked to complete treatment sessions over the course of 12 to 18 weeks. Those in the standard medical care arm will continue to receive their routine care with their clinicians.
All participants regardless of group assignment, will complete a total of five in-person clinic visits at the following time points: Baseline, 6 weeks, 12 weeks, 8 Months and 12 Months. These visits will include the completion of interview questions and self-report surveys that will assess functional status, quality of life and mFND symptoms.
Please see the "Arms and Interventions" section to see a more detailed description of each group/arm.
The goal of this Clinical Trial is to investigate the feasibility and efficacy of Neuro-Behavioral Therapy in Individuals aged 18 to 100 diagnosed with Motor Functional Neurologic Disorder. The main questions this study aims to answer are:
Aim 1: Examine the feasibility, acceptability, and practicality of manualized Neuro-Behavioral Therapy (NBT) in Functional Neurological Disorder (FND).
Hypothesis 1: Manualized NBT will demonstrate feasibility through acceptability and practicality, defined as ≥80% of participants enrolling in the study will participate in the study measures (acceptability) and complete the entire study protocol (practicality), respectively.
Aim 2: Examine the preliminary effectiveness of manualized NBT in improving health-related quality of life and reducing the severity and disability of mFNDs, as measured by the SF-36 and PMDRS/S-FMDRS (primary outcome), respectively.
Hypothesis 2: NBT will show improvements in SF-36 scores and reductions in PMDRS scores. We will evaluate this by conducting a preliminary examination of the manualized NBT intervention, with a focus on interpreting effect sizes. We will also gather key statistics needed to inform a fully powered clinical trial, such as the standard deviation and pre-post correlation of the SF-36 and PMDRS.
- Conditions
- Functional Neurological Disorder
- Being tested
- Neuro-behavioral Therapy, Standard Medical Care (SMC)
- Keywords
- mFND, Conversion Disorder, Functional Neurologic Disorder, Neurobehavioral Therapy, FND, Psychogenic Movement Disorder, Psychotherapy, motor functional neurological disorder, functional motor disorder
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-behavioral TherapyBehavioural
Also called Taking Control of Your Functional Motor Disorder Workbook
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuro-Behavioral Therapy | Experimental | 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. Receives: Behavioral: Neuro-behavioral Therapy |
| Standard Medical Care | Active comparator | 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. Receives: Other: Standard Medical Care (SMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 6, Week 12, 8 Months and 12 Months
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.
Measured: Baseline, Week 6, Week 12, 8 Months and 12 Months
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.
Measured: Baseline, Week 6, Week 12, 8 Months and 12 Months
Secondary outcomes (12)
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.
Measured: Baseline, Week 6, Week 12, 8 Months and 12 Months
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.
Measured: Baseline, Week 6, Week 12, 8 Months and 12 Months
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.
Measured: Baseline, Week 6, Week 12, 8 Months and 12 Months
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.
Measured: Baseline, Week 6, Week 12, 8 Months and 12 Months
Global Assessment of Functioning (GAF)
This GAF rating scale ranges from 0 (worst) to 100 (best) and is used for evaluating the overall functioning and symptoms of an individual during a specified time period on a continuum from psychological or psychiatric sickness to health.
Measured: Baseline, Week 6, Week 12, 8 Months and 12 Months
Clinical Global Impressions - Severity (CGI-S)
The CGI-S is the first item of a two-item global rating scale, where each item is on a 7 point scale ranging from normal ("1") to among the most extremely ill patients ("7"). A higher score relates to a higher severity of illness.
Measured: Baseline, Week 6, Week 12, 8 Months and 12 Months
Clinical Global Impressions - Improvement (CGI-I)
The CGI-I is the second item of a two item global rating scale, where each item is on a 7 point scale ranging from very much improved ("1") to very much worse ("7"). A lower score represents a higher improvement.
Measured: Baseline, Week 6, Week 12, 8 Months and 12 Months
World Health Organization: Quality of Life - BREF (WHOQOL-BREF)
This is a 27-item self-report scale to evaluate Quality of Life. The lowest possible score is 0 and the highest possible score is 100, reflecting a better quality of life.
Measured: Baseline, Week 6, Week 12, 8 Months and 12 Months
Patient Reported Outcome Measurement Information System (PROMIS) 29+2 v2.1
The PROMIS 29+2 v.2.1 is a 29 item self-report measure that assesses seven key health domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference.
Measured: Baseline, Week 6, Week 12, 8 Months and 12 Months
Multidimensional Health Locus of Control (MHLC-C)
The MHLC-C is a 18 item self-report measure that assesses how individuals view control over their health when dealing with a specific condition. It looks at three beliefs: (1) whether individuals feel in control of their health (Internal), (2) whether individuals rely on doctors or others (Powerful Others), or (3) whether individuals think health is mostly luck or chance (Chance). This survey helps to understand how these three beliefs may influence how individuals manage their condition.
Measured: Baseline, Week 6, Week 12, 8 Months and 12 Months
Traumatic Life Events Questionnaire (TLEQ)
The TLEQ is a 17-item self-report measure that assesses individuals experiences with potentially traumatic events, such as accidents, natural disasters, or violence. The TLEQ helps to identify whether someone has been exposed to trauma, how often these events have occurred and how impact or distressing these events were on ones well-being.
Measured: Baseline
Montreal Cognitive Assessment (MoCA)
The MoCA is a 30 item assessment tool used to detect mild cognitive impairment by evaluating various cognitive domains like memory, attention, language, visuospatial abilities, executive function, and orientation. The scale has a total possible score of 30 points, where a score of 26 or higher is typically considered normal while a lower score may indicate potential cognitive impairment.
Measured: Baseline, Week 12, and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start25 Sep 2024
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Neurological DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W. Curt LaFrance Jr., MD, MPH, Rhode Island Hospital
- Investigators
- W. Curt LaFrance Jr, MD, MPH, Principal investigator, Brown University HealthEmily Weisbach, MD, Study chair, Brown University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873698
- Sponsor's protocol ID
- 2136841
- Acronym
- NBT for mFND
- Status last verified
- Jul 2026
- First submitted
- 7 Mar 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data used in the current study will be available after termination of the embargo period or upon reasonable request from the authors with regulatory approval.
Publications
LaFrance WC Jr, Tedesco R, Baird GL, Wincze J, Tocco K, Anderson J. Clinician-rated outcomes of patients with functional neurological disorders treated in an outpatient clinic. Seizure. 2023 Apr;107:21-27. doi: 10.1016/j.seizure.2023.03.005. Epub 2023 Mar 12.
PubMed 36933399
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial (RCT) of Neurobehavioral Therapy (NBT) vs Standard Medical Care (SMC) for Functional Neurological Disorder (FND)
- ClinicalTrials.gov ID
- NCT06873698
- Acronym / sponsor ID
- NBT for mFND / 2136841
- Conditions
- Functional Neurological Disorder
- Keywords
- mFND, Conversion Disorder, Functional Neurologic Disorder, Neurobehavioral Therapy, FND, Psychogenic Movement Disorder, Psychotherapy, motor functional neurological disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study aims to enroll 40 participants at Rhode Island Hospital. 20 participants with Motor Functional Neurological Disorder (mFND) will be randomized to Neurobehavioral Therapy (Group 1) and 20 participants with mFND to Standard Medical Care (Group 2). Those randomized to neurobehavioral therapy will be asked to complete treatment sessions over the course of 12 to 18 weeks. Those in the standard medical care arm will continue to receive their routine care with their clinicians.
All participants regardless of group assignment, will complete a total of five in-person clinic visits at the following time points: Baseline, 6 weeks, 12 weeks, 8 Months and 12 Months. These visits will include the completion of interview questions and self-report surveys that will assess functional status, quality of life and mFND symptoms.
Please see the "Arms and Interventions" section to see a more detailed description of each group/arm.
The goal of this Clinical Trial is to investigate the feasibility and efficacy of Neuro-Behavioral Therapy in Individuals aged 18 to 100 diagnosed with Motor Functional Neurologic Disorder. The main questions this study aims to answer are:
Aim 1: Examine the feasibility, acceptability, and practicality of manualized Neuro-Behavioral Therapy (NBT) in Functional Neurological Disorder (FND).
Hypothesis 1: Manualized NBT will demonstrate feasibility through acceptability and practicality, defined as ≥80% of participants enrolling in the study will participate in the study measures (acceptability) and complete the entire study protocol (practicality), respectively.
Aim 2: Examine the preliminary effectiveness of manualized NBT in improving health-related quality of life and reducing the severity and disability of mFNDs, as measured by the SF-36 and PMDRS/S-FMDRS (primary outcome), respectively.
Hypothesis 2: NBT will show improvements in SF-36 scores and reductions in PMDRS scores. We will evaluate this by conducting a preliminary examination of the manualized NBT intervention, with a focus on interpreting effect sizes. We will also gather key statistics needed to inform a fully powered clinical trial, such as the standard deviation and pre-post correlation of the SF-36 and PMDRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuro-Behavioral Therapy | Experimental | Behavioral: Neuro-behavioral TherapyParticipants 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. |
| Standard Medical Care | Active comparator | Other: Standard Medical Care (SMC)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 may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals diagnosed with Motor Functional Neurological Disorder (mFND)
- Individuals aged 18-100 years
- At least 1 mFND symptom during the year prior to enrollment
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuro-behavioral TherapyAlso: Taking Control of Your Functional Motor Disorder WorkbookNeuro-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). | Behavioural | Neuro-Behavioral Therapy |
| 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. | Other | Standard Medical Care |
Primary outcome
SF-36 Health Survey (SF-36)
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
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.
Psychogenic Movement Disorders Rating Scale (PMDRS)
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
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.
Simplified Functional Movement Disorders Rating Scale (S-FMDRS)
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
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.
12 secondary outcomes
Generalized Anxiety Disorder (GAD-7)
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Patient Health Questionnaire (PHQ-15)
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Posttraumatic Scale Checklist-5 (PCL-5)
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Global Assessment of Functioning (GAF)
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Clinical Global Impressions - Severity (CGI-S)
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Clinical Global Impressions - Improvement (CGI-I)
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
World Health Organization: Quality of Life - BREF (WHOQOL-BREF)
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Patient Reported Outcome Measurement Information System (PROMIS) 29+2 v2.1
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Multidimensional Health Locus of Control (MHLC-C)
Time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months
Traumatic Life Events Questionnaire (TLEQ)
Time frame: Baseline
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, Week 12, and 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 36933399LaFrance WC Jr, Tedesco R, Baird GL, Wincze J, Tocco K, Anderson J. Clinician-rated outcomes of patients with functional neurological disorders treated in an outpatient clinic. Seizure. 2023 Apr;107:21-27. doi: 10.1016/j.seizure.2023.03.005. Epub 2023 Mar 12.
- Individual participant dataSharing planned: Yes. Anonymized data used in the current study will be available after termination of the embargo period or upon reasonable request from the authors with regulatory approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
W. Curt LaFrance Jr, MD, MPH principal investigator
Brown University Health
Emily Weisbach, MD study chair
Brown University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-behavioral Therapy and Standard Medical Care (SMC) in people with Functional Neurological Disorder, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis Sr. Clinical Research Assistant (401-606-4651, ademarco@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 Health Survey (SF-36) (time frame: Baseline, Week 6, Week 12, 8 Months and 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06873698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.