Functional Neurological DisorderNCT03731078
Pilot Study of Cognitive Behavioral Therapy-Informed Physical Therapy Intervention in Functional Neurological Disorders
An observational study of Functional Neurological Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Functional Neurological Disorder (FND/ Conversion Disorder) is a highly prevalent and disabling neuropsychiatric condition. Motor FND symptoms include Functional Movement Disorders (FMD) and Functional Weakness and Psychogenic Nonepileptic Seizures (PNES).Though patients with FND present with a wide variety of… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Functional Neurological Disorder
- What is being tested?
- CBT Informed physical therapy Intervention
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2019to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: motor functional neurological disorder
Who may be able to join
- FND patients will be recruited from the FND clinic and allied neurology and psychiatry clinics at Massachusetts General Hospital, with additional recruitment occurring through the physical therapy department. This study aims to recruit a total of 70 patients with motor FND. FND subjects will meet established clinical diagnostic criteria and patients with functional weakness will be diagnosed by "positive" signs suggestive of functional weakness including but not limited to a positive Hoover's sign. Individuals with PNES who have a concurrent functional limb weakness and/or a functional movement disorder will also be recruited. In addition, all individuals will have a clinical indication for PT (i.e. limb weakness, gait difficulties, abnormal movements).
Who cannot join
- Any significant major neurological disorder resulting in specific MRI abnormalities (i.e. encephalomalacia, severe traumatic brain injury (TBI)), poorly controlled major medical illness with known central nervous system consequences, inability to read English, pregnancy, claustrophobia, or inability to satisfy MRI safety measures. Additionally, patients with isolated PNES will not be considered for this study.
- Note: individuals who are eligible for the study but have an MRI contraindication may be offered study enrollment with MRI data collection for participation in aim 3 of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Functional Neurological Disorder (FND/ Conversion Disorder) is a highly prevalent and disabling neuropsychiatric condition. Motor FND symptoms include Functional Movement Disorders (FMD) and Functional Weakness and Psychogenic Nonepileptic Seizures (PNES).Though patients with FND present with a wide variety of symptoms, FMD, PNES, and functional weakness may be viewed as overlapping conditions lying along a phenotypic spectrum for a single disorder. Patients with FND frequently present with psychiatric symptoms, including depression, anxiety, Borderline Personality Disorder, and Post-Traumatic Stress Disorder, alongside their physical symptoms. To treat these symptoms, patients with FND are frequently enrolled in physical therapy and cognitive behavioral therapy, which are considered usual care for FND at our center. Developing a further understanding of treatment outcome, including biomarkers of clinical improvement and psychometric factors associated with treatment response, could inform future interventions and better tailor treatments to patients with specific FND symptom profiles.
We hypothesize that treatment response will be associated with structural and functional alterations in salience network regions and that more adaptive neuropsychiatric profiles at baseline will predict a positive treatment outcome.
Read the detailed description
Functional Neurological Disorder (FND) (Conversion Disorder) is a poorly understood and prevalent somatoform disorder, making up 16% of outpatient neurology referrals. Patients with motor FND (mFND) are difficult to treat, result in major morbidity, and are costly to the US. An estimated $256 billion is spent annually treating this population. mFND includes Functional Movement Disorders (FMD), Functional Weakness (FW) and Psychogenic Nonepileptic Seizures (PNES).
This project will investigate brain network profiles associated with and predictive of clinical improvement in patients with Functional Neurological Disorder (FND) following a 12-week cognitive behavioral therapy-informed physical therapy treatment program. Integrated physical therapy along with self-guided cognitive behavioral therapy is usual care for patients with FND experiencing motor symptoms at the Massachusetts General Hospital. Patients with motor FND experience significant impairment and often face issues with treatment management. Recent advancements in clinical research, catalyzed by new diagnostic criteria and an updated care model, have emphasized physical therapy and cognitive behavioral therapy as important evidence-based treatments for this population. Additionally, developments in neuroscience have allowed for a more comprehensive understanding of the neurobiology of FND. However, there has been limited investigation of longitudinal biomarkers associated with and predictive of treatment response, highlighting the need for an improved understanding of neurobiological changes underlying prognosis in FND.
We propose acquiring structural and functional brain imaging data in combination with psychometric assessments and patient chart review to examine neurobiological mechanisms of associated with participation in a cognitive behavioral therapy-informed physical therapy treatment program for patients with FND.
Primary Aim and Hypotheses The primary goal of this study is to provide structural and functional biomarkers related to and predictive of treatment response and clinical outcome in patients with motor FND following a 12-week cognitive behavioral therapy-informed physical therapy treatment program (usual care).
Specific Aim 1:
SA1) Identify structural MRI biomarkers linked to and predictive of improvement following cognitive behavioral therapy-informed physical therapy in FND.
Hypotheses: Improvement will correlate with increased volume, cortical thickness, and/or white matter integrity in salience network-related regions post- versus pre- treatment. Pre-treatment (baseline) salience network volume, cortical thickness, and/or white mater integrity will predict clinical outcome of the 12-week treatment program.
Specific Aim 2:
SA2) Identify resting-state functional MRI biomarkers linked to and predictive of improvement following cognitive behavioral therapy-informed physical therapy in FND.
Hypotheses: Improvement will correlate with reduced post- versus pre- treatment salience-somatomotor network resting state functional connectivity, and pre-treatment salience-somatomotor network functional connectivity strength will predict clinical outcome.
SA3) Identify baseline psychometric factors that correlate with clinical improvement (post vs. pre-treatment), including differences among FND sub-populations and baseline predictors of clinical improvement in FND.
Hypotheses: FND patients with more adaptive psychological profiles at baseline will be more responsive to treatment.
- Conditions
- Functional Neurological Disorder
- Being tested
- CBT Informed physical therapy Intervention
- Keywords
- Conversion Disorder, Functional Limb Weakness, Functional Movement 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.
CBT Informed physical therapy InterventionOther
The 12 physical therapy sessions delivered in Massachusetts General Hospital outpatient physical therapy sites sessions include:1) evaluation and education; 2) strategy identification and goal setting; 3) functional strengthening part one; 4) functional strengthening part two; 5) pre-gait activities with distraction; 6) gait training with distraction and use of strategies; 7) minimizing tremor with use of strategies; 8) higher level balance training; 9) functional reintegration part one; 10) functional reintegration part two; 11) identification of strategies to limit recurrence; 12) education for relapse prevention.Patients will also be given and asked to complete the self-guided CBT workbookL Overcoming Functional Neurological Symptoms: A Five Area Approach. They will be asked to complete the first two chapters over the first 4 weeks and the remaining 8 chapters over the following 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Motor Functional Neurological Disorder | The cohort will consist of patients with clinically-established motor functional neurological disorder, which includes individuals with functional movement disorders and functional limb weakness. Individuals with functional movement disorders and/or functional limb weakness who also have psychogenic nonepileptic seizures will be included. Patients will receive CBT informed PT intervention. The physical therapy intervention will be usual care in FND and based on consensus recommendations, clinical trials and good practices. Receives: Other: CBT Informed physical therapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form Health Survery 36 (SF-36)
questionnaire to identify change in health-related quality of life post vs. pre-treatment
Measured: 1-5 years
Secondary outcomes (7)
Screening for Somatoform Symptoms Conversion Disorder subscale (SOMS:CD)
composite score post vs. pre-treatment
Measured: 1-5 years
Patient Health Questionnaire-15 (PHQ-15)
composite score post vs. pre-treatment
Measured: 1-5 years
Clinical Global Impressions (CGI) - clinician rated scale
clinical global impression of improvement as rated by clinician
Measured: 1-5 years
Clinical Global Impressions (CGI) - patient rated
clinical global impression of improvement as rated by patient
Measured: 1-5 years
10meter walk test
change in post vs. pre-treatment speed of walking at preferred pace
Measured: 1-5 years
Five Times Sit to Stand test
change in post vs. pre-treatment time to move from sitting to standing five times
Measured: 1-5 years
Simplified Functional Movement Disorders Rating Scale (S-FMDRS)
clinician rated functional neurological symptom severity scale
Measured: 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start8 Mar 2019
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: Study as designed did not prove feasible with the challenges faced amidst the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neurological DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Lewis Perez, Massachusetts General Hospital
- Investigators
- David L Perez, MD, MMSc, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731078
- Sponsor's protocol ID
- 2018P001674
- Status last verified
- Sep 2021
- First submitted
- 2 Nov 2018
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Cognitive Behavioral Therapy-Informed Physical Therapy Intervention in Functional Neurological Disorders
- ClinicalTrials.gov ID
- NCT03731078
- Acronym / sponsor ID
- 2018P001674
- Conditions
- Functional Neurological Disorder
- Keywords
- Conversion Disorder, Functional Limb Weakness, Functional Movement Disorder
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study as designed did not prove feasible with the challenges faced amidst the COVID-19 pandemic
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 6 Nov 2018 (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.
Functional Neurological Disorder (FND/ Conversion Disorder) is a highly prevalent and disabling neuropsychiatric condition. Motor FND symptoms include Functional Movement Disorders (FMD) and Functional Weakness and Psychogenic Nonepileptic Seizures (PNES).Though patients with FND present with a wide variety of symptoms, FMD, PNES, and functional weakness may be viewed as overlapping conditions lying along a phenotypic spectrum for a single disorder. Patients with FND frequently present with psychiatric symptoms, including depression, anxiety, Borderline Personality Disorder, and Post-Traumatic Stress Disorder, alongside their physical symptoms. To treat these symptoms, patients with FND are frequently enrolled in physical therapy and cognitive behavioral therapy, which are considered usual care for FND at our center. Developing a further understanding of treatment outcome, including biomarkers of clinical improvement and psychometric factors associated with treatment response, could inform future interventions and better tailor treatments to patients with specific FND symptom profiles.
We hypothesize that treatment response will be associated with structural and functional alterations in salience network regions and that more adaptive neuropsychiatric profiles at baseline will predict a positive treatment outcome.
Detailed description
Functional Neurological Disorder (FND) (Conversion Disorder) is a poorly understood and prevalent somatoform disorder, making up 16% of outpatient neurology referrals. Patients with motor FND (mFND) are difficult to treat, result in major morbidity, and are costly to the US. An estimated $256 billion is spent annually treating this population. mFND includes Functional Movement Disorders (FMD), Functional Weakness (FW) and Psychogenic Nonepileptic Seizures (PNES).
This project will investigate brain network profiles associated with and predictive of clinical improvement in patients with Functional Neurological Disorder (FND) following a 12-week cognitive behavioral therapy-informed physical therapy treatment program. Integrated physical therapy along with self-guided cognitive behavioral therapy is usual care for patients with FND experiencing motor symptoms at the Massachusetts General Hospital. Patients with motor FND experience significant impairment and often face issues with treatment management. Recent advancements in clinical research, catalyzed by new diagnostic criteria and an updated care model, have emphasized physical therapy and cognitive behavioral therapy as important evidence-based treatments for this population. Additionally, developments in neuroscience have allowed for a more comprehensive understanding of the neurobiology of FND. However, there has been limited investigation of longitudinal biomarkers associated with and predictive of treatment response, highlighting the need for an improved understanding of neurobiological changes underlying prognosis in FND.
We propose acquiring structural and functional brain imaging data in combination with psychometric assessments and patient chart review to examine neurobiological mechanisms of associated with participation in a cognitive behavioral therapy-informed physical therapy treatment program for patients with FND.
Primary Aim and Hypotheses The primary goal of this study is to provide structural and functional biomarkers related to and predictive of treatment response and clinical outcome in patients with motor FND following a 12-week cognitive behavioral therapy-informed physical therapy treatment program (usual care).
Specific Aim 1:
SA1) Identify structural MRI biomarkers linked to and predictive of improvement following cognitive behavioral therapy-informed physical therapy in FND.
Hypotheses: Improvement will correlate with increased volume, cortical thickness, and/or white matter integrity in salience network-related regions post- versus pre- treatment. Pre-treatment (baseline) salience network volume, cortical thickness, and/or white mater integrity will predict clinical outcome of the 12-week treatment program.
Specific Aim 2:
SA2) Identify resting-state functional MRI biomarkers linked to and predictive of improvement following cognitive behavioral therapy-informed physical therapy in FND.
Hypotheses: Improvement will correlate with reduced post- versus pre- treatment salience-somatomotor network resting state functional connectivity, and pre-treatment salience-somatomotor network functional connectivity strength will predict clinical outcome.
SA3) Identify baseline psychometric factors that correlate with clinical improvement (post vs. pre-treatment), including differences among FND sub-populations and baseline predictors of clinical improvement in FND.
Hypotheses: FND patients with more adaptive psychological profiles at baseline will be more responsive to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motor Functional Neurological Disorder | – | Other: CBT Informed physical therapy InterventionThe cohort will consist of patients with clinically-established motor functional neurological disorder, which includes individuals with functional movement disorders and functional limb weakness. Individuals with functional movement disorders and/or functional limb weakness who also have psychogenic nonepileptic seizures will be included. Patients will receive CBT informed PT intervention. The physical therapy intervention will be usual care in FND and based on consensus recommendations, clinical trials and good practices. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- motor functional neurological disorder
Key inclusion criteria (1 listed)
- FND patients will be recruited from the FND clinic and allied neurology and psychiatry clinics at Massachusetts General Hospital, with additional recruitment occurring through the physical therapy department. This study aims to recruit a total of 70 patients with motor FND. FND subjects will meet established clinical diagnostic criteria and patients with functional weakness will be diagnosed by "positive" signs suggestive of functional weakness including but not limited to a positive Hoover's sign. Individuals with PNES who have a concurrent functional limb weakness and/or a functional movement disorder will also be recruited. In addition, all individuals will have a clinical indication for PT (i.e. limb weakness, gait difficulties, abnormal movements).
Key exclusion criteria (2 listed)
- Any significant major neurological disorder resulting in specific MRI abnormalities (i.e. encephalomalacia, severe traumatic brain injury (TBI)), poorly controlled major medical illness with known central nervous system consequences, inability to read English, pregnancy, claustrophobia, or inability to satisfy MRI safety measures. Additionally, patients with isolated PNES will not be considered for this study.
- Note: individuals who are eligible for the study but have an MRI contraindication may be offered study enrollment with MRI data collection for participation in aim 3 of this 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 |
|---|---|---|
| CBT Informed physical therapy InterventionThe 12 physical therapy sessions delivered in Massachusetts General Hospital outpatient physical therapy sites sessions include:1) evaluation and education; 2) strategy identification and goal setting; 3) functional strengthening part one; 4) functional strengthening part two; 5) pre-gait activities with distraction; 6) gait training with distraction and use of strategies; 7) minimizing tremor with use of strategies; 8) higher level balance training; 9) functional reintegration part one; 10) functional reintegration part two; 11) identification of strategies to limit recurrence; 12) education for relapse prevention.Patients will also be given and asked to complete the self-guided CBT workbookL Overcoming Functional Neurological Symptoms: A Five Area Approach. They will be asked to complete the first two chapters over the first 4 weeks and the remaining 8 chapters over the following 8 weeks. | Other | Motor Functional Neurological Disorder |
Primary outcome
Short Form Health Survery 36 (SF-36)
Time frame: 1-5 years
questionnaire to identify change in health-related quality of life post vs. pre-treatment
7 secondary outcomes
Screening for Somatoform Symptoms Conversion Disorder subscale (SOMS:CD)
Time frame: 1-5 years
Patient Health Questionnaire-15 (PHQ-15)
Time frame: 1-5 years
Clinical Global Impressions (CGI) - clinician rated scale
Time frame: 1-5 years
Clinical Global Impressions (CGI) - patient rated
Time frame: 1-5 years
10meter walk test
Time frame: 1-5 years
Five Times Sit to Stand test
Time frame: 1-5 years
Simplified Functional Movement Disorders Rating Scale (S-FMDRS)
Time frame: 1-5 years
Results and safety
The study was stopped early (reason given: Study as designed did not prove feasible with the challenges faced amidst the COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Functional Neurological Disorder
RecruitingPhase 4
ASsessing The REAl-world Safety & Effectiveness of Spinal Muscular Atrophy Participants Treated With Intrathecal Onasemnogene Abeparvovec-brve (OAV101B) (ITVISMA®): A U.S. Pragmatic Multicenter Study (STREAM)
Spinal Muscular Atrophy
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
RecruitingObservational study
Long-Term Follow-Up of Survivors of Pediatric Cushing Disease
Cushing Disease
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. This study is not recruiting at the moment.
David L Perez, MD, MMSc principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Neurological Disorder, run by Massachusetts General 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 9 Sep 2021. 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?
The study was stopped early (reason given: Study as designed did not prove feasible with the challenges faced amidst the COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form Health Survery 36 (SF-36) (time frame: 1-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2021.