Functional Movement DisordersNCT05201521
Chinese FMDs Registry
An observational study of Functional Movement Disorders, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of the Chinese Functional Movement Disorders Registry (FMDs-China) is to develop a database of patients with Functional Movement Disorders (FMDs) in China. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Movement Disorders
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2022to 27 Jan 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: At least 100 patents coming from hospitals or communities in mainland China
Who may be able to join
- Male or female;
- Age 18-80;
- Patients clinically diagnosed with functional movement disorders according to the Fahn-Williams criteria;
- Patients who are willing to provide information such as disease history and cooperate with physical examination and examination;
Who cannot join
- Patients with definite organic dyskinesia;
- There are other causes of dyskinesia such as fatigue, pain, hyperthyroidism, chronic alcoholism, and drug use;
- Those who suffer from serious physical diseases and are unable to cooperate;
- Those who do not cooperate or refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Jintao Wang, 15068171732, jt_wang@sjtu.edu.cn
About this study
Official title: The Chinese Functional Movement Disorders Registry Study
The purpose of the Chinese Functional Movement Disorders Registry (FMDs-China) is to develop a database of patients with Functional Movement Disorders (FMDs) in China.
Read the detailed description
Functional movement disorders (FMDs), also known as psychogenic movement disorders (PMDs), formerly known as "hysteria or hysteria", is a representative functional nervous system disease. It has been reported in Europe and America that FMDs patients account for 3% - 6% of all patients in the outpatient department of motor disorders, but there is no relevant data report in China so far. From the current research, the incidence rate has gradually increased significantly. However, the research about the pathogenesis and diagnosis of such diseases is rare. These studies have the problem of small sample size and still lack large randomized controlled studies to demonstrate the long-term efficacy of different treatments. And in China, there are nearly no reliable research and the lack of basic understanding makes it a "gray area" for the diagnosis and treatment of FMDs.
The purpose of this observational study is to prospectively register the information of patients with FMDs nationwide, establishing a Chinese multicenter FMDs China cohort; understanding the demographic characteristics, clinical characteristics and symptom characteristics, neuropsychological test, electrophysiological and imaging characteristics, drug use, etc. what's more, it lays a foundation for the research on the etiology and treatment in the second stage of this study.
- Conditions
- Functional Movement Disorders
- Medical subject headings
- Conversion Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
The symptom characteristics
Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.
Measured: baseline
The symptom characteristics
Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.
Measured: 0.5 years
The symptom characteristics
Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.
Measured: 1.5 years
The symptom characteristics
Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.
Measured: 2 years
The movement disorder attack video
The video is taken as the protocol below: full body view of the participant sitting in a chair with arm rests (15 seconds); close up of face and neck (15 seconds), the participant was then asked to recite the months of the year; full body view sitting with hands supine resting on thighs (15 seconds); arms extended at shoulder height with hands in pronation (10 seconds); finger-nose test (5 repetitions); thumb and index-finger finger taps (15 seconds); heel taps (15 seconds); moving from sitting to standing; standing with posture uncorrected (10 seconds); standing with feet touching (10 seconds); and finally walking 5 meters, turn and walking back to the starting position (using aids if necessary). All video was filmed in a frontal view.
Measured: baseline
The movement disorder attack video
The video is taken as the protocol below: full body view of the participant sitting in a chair with arm rests (15 seconds); close up of face and neck (15 seconds), the participant was then asked to recite the months of the year; full body view sitting with hands supine resting on thighs (15 seconds); arms extended at shoulder height with hands in pronation (10 seconds); finger-nose test (5 repetitions); thumb and index-finger finger taps (15 seconds); heel taps (15 seconds); moving from sitting to standing; standing with posture uncorrected (10 seconds); standing with feet touching (10 seconds); and finally walking 5 meters, turn and walking back to the starting position (using aids if necessary). All video was filmed in a frontal view.
Measured: 0.5 years
The movement disorder attack video
The video is taken as the protocol below: full body view of the participant sitting in a chair with arm rests (15 seconds); close up of face and neck (15 seconds), the participant was then asked to recite the months of the year; full body view sitting with hands supine resting on thighs (15 seconds); arms extended at shoulder height with hands in pronation (10 seconds); finger-nose test (5 repetitions); thumb and index-finger finger taps (15 seconds); heel taps (15 seconds); moving from sitting to standing; standing with posture uncorrected (10 seconds); standing with feet touching (10 seconds); and finally walking 5 meters, turn and walking back to the starting position (using aids if necessary). All video was filmed in a frontal view.
Measured: 1.5 years
The movement disorder attack video
The video is taken as the protocol below: full body view of the participant sitting in a chair with arm rests (15 seconds); close up of face and neck (15 seconds), the participant was then asked to recite the months of the year; full body view sitting with hands supine resting on thighs (15 seconds); arms extended at shoulder height with hands in pronation (10 seconds); finger-nose test (5 repetitions); thumb and index-finger finger taps (15 seconds); heel taps (15 seconds); moving from sitting to standing; standing with posture uncorrected (10 seconds); standing with feet touching (10 seconds); and finally walking 5 meters, turn and walking back to the starting position (using aids if necessary). All video was filmed in a frontal view.
Measured: 2 years
The Simplified Functional Movement Disorders Rating Scale
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) is used to estimate the provide a snapshot symptom severity score and provide information on phenomenology, anatomical distribution, duration, and functional impact of abnormal movement. Symptom severity at 7 body region and 2 functions (gait and speech) are rated from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). A duration score was assigned to each body region and function (estimated amount of time in the video during which symptoms are observed at the body region), rated from 0 to 3 (0 = none; 1 = symptomatic movement spotted at least once or only a few times; 2 = symptom is intermittent but frequent so that there are periods during which it is absent or does not affect purposeful movement; 3 = the symptom is evident continuously). The total score is 54, the minimum is 0, higher scores indicate more severe disease.
Measured: baseline
The Simplified Functional Movement Disorders Rating Scale
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) is used to estimate the provide a snapshot symptom severity score and provide information on phenomenology, anatomical distribution, duration, and functional impact of abnormal movement. Symptom severity at 7 body region and 2 functions (gait and speech) are rated from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). A duration score was assigned to each body region and function (estimated amount of time in the video during which symptoms are observed at the body region), rated from 0 to 3 (0 = none; 1 = symptomatic movement spotted at least once or only a few times; 2 = symptom is intermittent but frequent so that there are periods during which it is absent or does not affect purposeful movement; 3 = the symptom is evident continuously). The total score is 54, the minimum is 0, higher scores indicate more severe disease.
Measured: 0.5 years
The Simplified Functional Movement Disorders Rating Scale
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) is used to estimate the provide a snapshot symptom severity score and provide information on phenomenology, anatomical distribution, duration, and functional impact of abnormal movement. Symptom severity at 7 body region and 2 functions (gait and speech) are rated from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). A duration score was assigned to each body region and function (estimated amount of time in the video during which symptoms are observed at the body region), rated from 0 to 3 (0 = none; 1 = symptomatic movement spotted at least once or only a few times; 2 = symptom is intermittent but frequent so that there are periods during which it is absent or does not affect purposeful movement; 3 = the symptom is evident continuously). The total score is 54, the minimum is 0, higher scores indicate more severe disease.
Measured: 1 years
The Simplified Functional Movement Disorders Rating Scale
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) is used to estimate the provide a snapshot symptom severity score and provide information on phenomenology, anatomical distribution, duration, and functional impact of abnormal movement. A duration score was assigned to each body region and function (estimated amount of time in the video during which symptoms are observed at the body region), rated from 0 to 3 (0 = none; 1 = symptomatic movement spotted at least once or only a few times; 2 = symptom is intermittent but frequent so that there are periods during which it is absent or does not affect purposeful movement; 3 = the symptom is evident continuously). The total score is 54, the minimum is 0, higher scores indicate more severe disease.
Measured: 1.5 years
The Simplified Functional Movement Disorders Rating Scale
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) is used to estimate the provide a snapshot symptom severity score and provide information on phenomenology, anatomical distribution, duration, and functional impact of abnormal movement. A duration score was assigned to each body region and function (estimated amount of time in the video during which symptoms are observed at the body region), rated from 0 to 3 (0 = none; 1 = symptomatic movement spotted at least once or only a few times; 2 = symptom is intermittent but frequent so that there are periods during which it is absent or does not affect purposeful movement; 3 = the symptom is evident continuously). The total score is 54, the minimum is 0, higher scores indicate more severe disease.
Measured: 2 years
Secondary outcomes (25)
Hamilton Depression Scale
Hamilton Depression Scale (HAMD) was designed to measure frequency and intensity of depressive symptoms in individuals with major depressive disorder. Scores between 0 and 6 do not indicate the presence of depression' scores between 7 and 17 indicate mild depression' scores between 18 and 24 indicate moderate depression' and scores over 24 indicate severe depression.
Measured: baseline
Hamilton Depression Scale
Hamilton Depression Scale (HAMD) was designed to measure frequency and intensity of depressive symptoms in individuals with major depressive disorder. Scores between 0 and 6 do not indicate the presence of depression' scores between 7 and 17 indicate mild depression' scores between 18 and 24 indicate moderate depression' and scores over 24 indicate severe depression.
Measured: 0.5 years
Hamilton Depression Scale
Hamilton Depression Scale (HAMD) was designed to measure frequency and intensity of depressive symptoms in individuals with major depressive disorder. Scores between 0 and 6 do not indicate the presence of depression' scores between 7 and 17 indicate mild depression' scores between 18 and 24 indicate moderate depression' and scores over 24 indicate severe depression.
Measured: 1 years
Hamilton Depression Scale
Hamilton Depression Scale (HAMD) was designed to measure frequency and intensity of depressive symptoms in individuals with major depressive disorder. Scores between 0 and 6 do not indicate the presence of depression' scores between 7 and 17 indicate mild depression' scores between 18 and 24 indicate moderate depression' and scores over 24 indicate severe depression.
Measured: 1.5 years
Hamilton Depression Scale
Hamilton Depression Scale (HAMD) was designed to measure frequency and intensity of depressive symptoms in individuals with major depressive disorder. Scores between 0 and 6 do not indicate the presence of depression' scores between 7 and 17 indicate mild depression' scores between 18 and 24 indicate moderate depression' and scores over 24 indicate severe depression.
Measured: 2 years
Beck Anxiety Inventory
Beck Anxiety Inventory (BAI) is a self-report measure of anxiety.The total score is calculated by finding the sum of the 21 items.Score of 0 - 21 = low anxiety;Score of 22 - 35 = moderate anxiety;Score of 36 and above = potentially concerning levels of anxiety
Measured: baseline
Beck Anxiety Inventory
Beck Anxiety Inventory (BAI) is a self-report measure of anxiety.The total score is calculated by finding the sum of the 21 items.Score of 0 - 21 = low anxiety;Score of 22 - 35 = moderate anxiety;Score of 36 and above = potentially concerning levels of anxiety
Measured: 0.5 years
Beck Anxiety Inventory
Beck Anxiety Inventory (BAI) is a self-report measure of anxiety.The total score is calculated by finding the sum of the 21 items.Score of 0 - 21 = low anxiety;Score of 22 - 35 = moderate anxiety;Score of 36 and above = potentially concerning levels of anxiety
Measured: 1 years
Beck Anxiety Inventory
Beck Anxiety Inventory (BAI) is a self-report measure of anxiety.The total score is calculated by finding the sum of the 21 items.Score of 0 - 21 = low anxiety;Score of 22 - 35 = moderate anxiety;Score of 36 and above = potentially concerning levels of anxiety
Measured: 1.5 years
Beck Anxiety Inventory
Beck Anxiety Inventory (BAI) is a self-report measure of anxiety.The total score is calculated by finding the sum of the 21 items.Score of 0 - 21 = low anxiety;Score of 22 - 35 = moderate anxiety;Score of 36 and above = potentially concerning levels of anxiety
Measured: 2 years
symptom check list-90
symptom check list-90 (SLC-90) is a 90-item self-report symptom inventory to measure psychological symptoms and psychological distress including Somatization, Obsessive-Compulsive, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Positive items refer to items with a single item score ≥ 2. According to the China national norm results, if the total score exceeds 160 points, or the number of positive items exceeds 43, the screening should be considered positive and further examination is required. The score of the total symptom index is between 1 and 1.5, indicating that the subject feels no symptoms; between 1.5 and 2.5, it indicates that the subject feels a little symptom, but it occurs infrequently; between 2.5 and 3.5, the severity was mild to moderate; between 3.5 and 4.5, the severity was moderate to severe; between 4.5 and 5, the frequency and intensity of symptoms are severe.
Measured: baseline
symptom check list-90
symptom check list-90 (SLC-90) is a 90-item self-report symptom inventory to measure psychological symptoms and psychological distress including Somatization, Obsessive-Compulsive, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Positive items refer to items with a single item score ≥ 2. According to the China national norm results, if the total score exceeds 160 points, or the number of positive items exceeds 43, the screening should be considered positive and further examination is required. The score of the total symptom index is between 1 and 1.5, indicating that the subject feels no symptoms; between 1.5 and 2.5, it indicates that the subject feels a little symptom, but it occurs infrequently; between 2.5 and 3.5, the severity was mild to moderate; between 3.5 and 4.5, the severity was moderate to severe; between 4.5 and 5, the frequency and intensity of symptoms are severe.
Measured: 0.5 years
symptom check list-90
symptom check list-90 (SLC-90) is a 90-item self-report symptom inventory to measure psychological symptoms and psychological distress including Somatization, Obsessive-Compulsive, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Positive items refer to items with a single item score ≥ 2. According to the China national norm results, if the total score exceeds 160 points, or the number of positive items exceeds 43, the screening should be considered positive and further examination is required. The score of the total symptom index is between 1 and 1.5, indicating that the subject feels no symptoms; between 1.5 and 2.5, it indicates that the subject feels a little symptom, but it occurs infrequently; between 2.5 and 3.5, the severity was mild to moderate; between 3.5 and 4.5, the severity was moderate to severe; between 4.5 and 5, the frequency and intensity of symptoms are severe.
Measured: 1 years
symptom check list-90
symptom check list-90 (SLC-90) is a 90-item self-report symptom inventory to measure psychological symptoms and psychological distress including Somatization, Obsessive-Compulsive, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Positive items refer to items with a single item score ≥ 2. According to the China national norm results, if the total score exceeds 160 points, or the number of positive items exceeds 43, the screening should be considered positive and further examination is required. The score of the total symptom index is between 1 and 1.5, indicating that the subject feels no symptoms; between 1.5 and 2.5, it indicates that the subject feels a little symptom, but it occurs infrequently; between 2.5 and 3.5, the severity was mild to moderate; between 3.5 and 4.5, the severity was moderate to severe; between 4.5 and 5, the frequency and intensity of symptoms are severe.
Measured: 1.5 years
symptom check list-90
symptom check list-90 (SLC-90) is a 90-item self-report symptom inventory to measure psychological symptoms and psychological distress including Somatization, Obsessive-Compulsive, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Positive items refer to items with a single item score ≥ 2. According to the China national norm results, if the total score exceeds 160 points, or the number of positive items exceeds 43, the screening should be considered positive and further examination is required. The score of the total symptom index is between 1 and 1.5, indicating that the subject feels no symptoms; between 1.5 and 2.5, it indicates that the subject feels a little symptom, but it occurs infrequently; between 2.5 and 3.5, the severity was mild to moderate; between 3.5 and 4.5, the severity was moderate to severe; between 4.5 and 5, the frequency and intensity of symptoms are severe.
Measured: 2 years
clinical global impression severity scale
clinical global impression severity scale (CGI-S) is used to estimate the overall measure of severity of a patient's illness. CGI-S (categories: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = extremely ill
Measured: baseline
clinical global impression severity scale
clinical global impression severity scale (CGI-S) is used to estimate the overall measure of severity of a patient's illness. CGI-S (categories: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = extremely ill
Measured: 0.5 years
clinical global impression severity scale
clinical global impression severity scale (CGI-S) is used to estimate the overall measure of severity of a patient's illness. CGI-S (categories: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = extremely ill
Measured: 1 years
clinical global impression severity scale
clinical global impression severity scale (CGI-S) is used to estimate the overall measure of severity of a patient's illness. CGI-S (categories: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = extremely ill
Measured: 1.5 years
clinical global impression severity scale
clinical global impression severity scale (CGI-S) is used to estimate the overall measure of severity of a patient's illness. CGI-S (categories: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = extremely ill
Measured: 2 years
Clinical global improvement scale
Clinical Global Impression Scale-improvement scale (CGI-I) has been widely utilized as an efficacy measure in clinical drug trials in different mental disorders.0: Very much; 1: improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; 7: Very much worse
Measured: baseline
Clinical global improvement scale
Clinical Global Impression Scale-improvement scale (CGI-I) has been widely utilized as an efficacy measure in clinical drug trials in different mental disorders.0: Very much; 1: improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; 7: Very much worse
Measured: 0.5 years
Clinical global improvement scale
Clinical Global Impression Scale-improvement scale (CGI-I) has been widely utilized as an efficacy measure in clinical drug trials in different mental disorders.0: Very much; 1: improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; 7: Very much worse
Measured: 1 year
Clinical global improvement scale
Clinical Global Impression Scale-improvement scale (CGI-I) has been widely utilized as an efficacy measure in clinical drug trials in different mental disorders.0: Very much; 1: improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; 7: Very much worse
Measured: 1.5 years
Clinical global improvement scale
Clinical Global Impression Scale-improvement scale (CGI-I) has been widely utilized as an efficacy measure in clinical drug trials in different mental disorders.0: Very much; 1: improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; 7: Very much worse
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start27 Jan 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion27 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Movement DisordersStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Wang, MD,PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201521
- Sponsor's protocol ID
- SN-01
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chinese Functional Movement Disorders Registry Study
- ClinicalTrials.gov ID
- NCT05201521
- Acronym / sponsor ID
- SN-01
- Conditions
- Functional Movement Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 27 Jan 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 27 Jan 2024 (estimated)
- First posted
- 21 Jan 2022 (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 purpose of the Chinese Functional Movement Disorders Registry (FMDs-China) is to develop a database of patients with Functional Movement Disorders (FMDs) in China.
Detailed description
Functional movement disorders (FMDs), also known as psychogenic movement disorders (PMDs), formerly known as "hysteria or hysteria", is a representative functional nervous system disease. It has been reported in Europe and America that FMDs patients account for 3% - 6% of all patients in the outpatient department of motor disorders, but there is no relevant data report in China so far. From the current research, the incidence rate has gradually increased significantly. However, the research about the pathogenesis and diagnosis of such diseases is rare. These studies have the problem of small sample size and still lack large randomized controlled studies to demonstrate the long-term efficacy of different treatments. And in China, there are nearly no reliable research and the lack of basic understanding makes it a "gray area" for the diagnosis and treatment of FMDs.
The purpose of this observational study is to prospectively register the information of patients with FMDs nationwide, establishing a Chinese multicenter FMDs China cohort; understanding the demographic characteristics, clinical characteristics and symptom characteristics, neuropsychological test, electrophysiological and imaging characteristics, drug use, etc. what's more, it lays a foundation for the research on the etiology and treatment in the second stage of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At least 100 patents coming from hospitals or communities in mainland China
Key inclusion criteria (4 listed)
- Male or female;
- Age 18-80;
- Patients clinically diagnosed with functional movement disorders according to the Fahn-Williams criteria;
- Patients who are willing to provide information such as disease history and cooperate with physical examination and examination;
Key exclusion criteria (4 listed)
- Patients with definite organic dyskinesia;
- There are other causes of dyskinesia such as fatigue, pain, hyperthyroidism, chronic alcoholism, and drug use;
- Those who suffer from serious physical diseases and are unable to cooperate;
- Those who do not cooperate or refuse to sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The symptom characteristics
Time frame: baseline
Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.
The symptom characteristics
Time frame: 0.5 years
Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.
The symptom characteristics
Time frame: 1.5 years
Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.
The symptom characteristics
Time frame: 2 years
Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.
The movement disorder attack video
Time frame: baseline
The video is taken as the protocol below: full body view of the participant sitting in a chair with arm rests (15 seconds); close up of face and neck (15 seconds), the participant was then asked to recite the months of the year; full body view sitting with hands supine resting on thighs (15 seconds); arms extended at shoulder height with hands in pronation (10 seconds); finger-nose test (5 repetitions); thumb and index-finger finger taps (15 seconds); heel taps (15 seconds); moving from sitting to standing; standing with posture uncorrected (10 seconds); standing with feet touching (10 seconds); and finally walking 5 meters, turn and walking back to the starting position (using aids if necessary). All video was filmed in a frontal view.
The movement disorder attack video
Time frame: 0.5 years
The video is taken as the protocol below: full body view of the participant sitting in a chair with arm rests (15 seconds); close up of face and neck (15 seconds), the participant was then asked to recite the months of the year; full body view sitting with hands supine resting on thighs (15 seconds); arms extended at shoulder height with hands in pronation (10 seconds); finger-nose test (5 repetitions); thumb and index-finger finger taps (15 seconds); heel taps (15 seconds); moving from sitting to standing; standing with posture uncorrected (10 seconds); standing with feet touching (10 seconds); and finally walking 5 meters, turn and walking back to the starting position (using aids if necessary). All video was filmed in a frontal view.
The movement disorder attack video
Time frame: 1.5 years
The video is taken as the protocol below: full body view of the participant sitting in a chair with arm rests (15 seconds); close up of face and neck (15 seconds), the participant was then asked to recite the months of the year; full body view sitting with hands supine resting on thighs (15 seconds); arms extended at shoulder height with hands in pronation (10 seconds); finger-nose test (5 repetitions); thumb and index-finger finger taps (15 seconds); heel taps (15 seconds); moving from sitting to standing; standing with posture uncorrected (10 seconds); standing with feet touching (10 seconds); and finally walking 5 meters, turn and walking back to the starting position (using aids if necessary). All video was filmed in a frontal view.
The movement disorder attack video
Time frame: 2 years
The video is taken as the protocol below: full body view of the participant sitting in a chair with arm rests (15 seconds); close up of face and neck (15 seconds), the participant was then asked to recite the months of the year; full body view sitting with hands supine resting on thighs (15 seconds); arms extended at shoulder height with hands in pronation (10 seconds); finger-nose test (5 repetitions); thumb and index-finger finger taps (15 seconds); heel taps (15 seconds); moving from sitting to standing; standing with posture uncorrected (10 seconds); standing with feet touching (10 seconds); and finally walking 5 meters, turn and walking back to the starting position (using aids if necessary). All video was filmed in a frontal view.
The Simplified Functional Movement Disorders Rating Scale
Time frame: baseline
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) is used to estimate the provide a snapshot symptom severity score and provide information on phenomenology, anatomical distribution, duration, and functional impact of abnormal movement. Symptom severity at 7 body region and 2 functions (gait and speech) are rated from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). A duration score was assigned to each body region and function (estimated amount of time in the video during which symptoms are observed at the body region), rated from 0 to 3 (0 = none; 1 = symptomatic movement spotted at least once or only a few times; 2 = symptom is intermittent but frequent so that there are periods during which it is absent or does not affect purposeful movement; 3 = the symptom is evident continuously). The total score is 54, the minimum is 0, higher scores indicate more severe disease.
The Simplified Functional Movement Disorders Rating Scale
Time frame: 0.5 years
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) is used to estimate the provide a snapshot symptom severity score and provide information on phenomenology, anatomical distribution, duration, and functional impact of abnormal movement. Symptom severity at 7 body region and 2 functions (gait and speech) are rated from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). A duration score was assigned to each body region and function (estimated amount of time in the video during which symptoms are observed at the body region), rated from 0 to 3 (0 = none; 1 = symptomatic movement spotted at least once or only a few times; 2 = symptom is intermittent but frequent so that there are periods during which it is absent or does not affect purposeful movement; 3 = the symptom is evident continuously). The total score is 54, the minimum is 0, higher scores indicate more severe disease.
The Simplified Functional Movement Disorders Rating Scale
Time frame: 1 years
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) is used to estimate the provide a snapshot symptom severity score and provide information on phenomenology, anatomical distribution, duration, and functional impact of abnormal movement. Symptom severity at 7 body region and 2 functions (gait and speech) are rated from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). A duration score was assigned to each body region and function (estimated amount of time in the video during which symptoms are observed at the body region), rated from 0 to 3 (0 = none; 1 = symptomatic movement spotted at least once or only a few times; 2 = symptom is intermittent but frequent so that there are periods during which it is absent or does not affect purposeful movement; 3 = the symptom is evident continuously). The total score is 54, the minimum is 0, higher scores indicate more severe disease.
The Simplified Functional Movement Disorders Rating Scale
Time frame: 1.5 years
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) is used to estimate the provide a snapshot symptom severity score and provide information on phenomenology, anatomical distribution, duration, and functional impact of abnormal movement. A duration score was assigned to each body region and function (estimated amount of time in the video during which symptoms are observed at the body region), rated from 0 to 3 (0 = none; 1 = symptomatic movement spotted at least once or only a few times; 2 = symptom is intermittent but frequent so that there are periods during which it is absent or does not affect purposeful movement; 3 = the symptom is evident continuously). The total score is 54, the minimum is 0, higher scores indicate more severe disease.
The Simplified Functional Movement Disorders Rating Scale
Time frame: 2 years
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) is used to estimate the provide a snapshot symptom severity score and provide information on phenomenology, anatomical distribution, duration, and functional impact of abnormal movement. A duration score was assigned to each body region and function (estimated amount of time in the video during which symptoms are observed at the body region), rated from 0 to 3 (0 = none; 1 = symptomatic movement spotted at least once or only a few times; 2 = symptom is intermittent but frequent so that there are periods during which it is absent or does not affect purposeful movement; 3 = the symptom is evident continuously). The total score is 54, the minimum is 0, higher scores indicate more severe disease.
25 secondary outcomes
Hamilton Depression Scale
Time frame: baseline
Hamilton Depression Scale
Time frame: 0.5 years
Hamilton Depression Scale
Time frame: 1 years
Hamilton Depression Scale
Time frame: 1.5 years
Hamilton Depression Scale
Time frame: 2 years
Beck Anxiety Inventory
Time frame: baseline
Beck Anxiety Inventory
Time frame: 0.5 years
Beck Anxiety Inventory
Time frame: 1 years
Beck Anxiety Inventory
Time frame: 1.5 years
Beck Anxiety Inventory
Time frame: 2 years
symptom check list-90
Time frame: baseline
symptom check list-90
Time frame: 0.5 years
symptom check list-90
Time frame: 1 years
symptom check list-90
Time frame: 1.5 years
symptom check list-90
Time frame: 2 years
clinical global impression severity scale
Time frame: baseline
clinical global impression severity scale
Time frame: 0.5 years
clinical global impression severity scale
Time frame: 1 years
clinical global impression severity scale
Time frame: 1.5 years
clinical global impression severity scale
Time frame: 2 years
Clinical global improvement scale
Time frame: baseline
Clinical global improvement scale
Time frame: 0.5 years
Clinical global improvement scale
Time frame: 1 year
Clinical global improvement scale
Time frame: 1.5 years
Clinical global improvement scale
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Individual participant dataSharing planned: Yes
Related trials for Functional Movement Disorders
Enrolling by invitation
Effect of Hand Rehabilitation on Cognitive Function in Patients With PD
PARKINSON DISEASE (Disorder)
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
Active, not recruitingObservational study
Feasibility of Vision-Language Models for Detecting Physical Assistance as an Observable Criterion Defining GMFCS Levels in Children Aged 2 to 6 Years With Cerebral Palsy
Cerebral Palsy
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
Recruiting
Dual Tasking Training to Enhance Self-Efficacy in Individuals With Parkinson's Disease
Parkinson´s 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.
Gang Wang, MD,PhD principal investigator
Ruijin 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 Movement Disorders, run by Ruijin Hospital at 1 site in China.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Jan 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Wang, MD,PhD (086-021-64370045, wg11424@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The symptom characteristics (time frame: baseline). The study lists 13 primary outcomes in all. 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 21 Jan 2022.