Chinese FMDs Registry

Functional Movement Disorders Clinical Trial

Official title:

The Chinese Functional Movement Disorders Registry Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05201521
• Other study ID #: SN-01
• Status: Not yet recruiting
• Start date: January 27, 2022
• Est. completion date: January 27, 2024

Study information

• Verified date: January 2022
• Source: Ruijin Hospital
• Contact: Gang Wang, MD,PhD
• Phone: 086-021-64370045
• Email: wg11424[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 27, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Functional Movement Disorders
• Movement Disorders

Locations

Country	Name	City	State
China	Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The symptom characteristics	Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.	1 years
Primary	The symptom characteristics	Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.	baseline
Primary	The symptom characteristics	Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.	0.5 years
Primary	The symptom characteristics	Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.	1.5 years
Primary	The symptom characteristics	Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.	2 years
Primary	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); ?nger-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 ?nally walking 5 meters, turn and walking back to the starting position (using aids if necessary). All video was ?lmed in a frontal view.	baseline
Primary	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); ?nger-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 ?nally walking 5 meters, turn and walking back to the starting position (using aids if necessary). All video was ?lmed in a frontal view.	0.5 years
Primary	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); ?nger-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 ?nally walking 5 meters, turn and walking back to the starting position (using aids if necessary). All video was ?lmed in a frontal view.	1.5 years
Primary	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); ?nger-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 ?nally walking 5 meters, turn and walking back to the starting position (using aids if necessary). All video was ?lmed in a frontal view.	2 years
Primary	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.	baseline
Primary	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.	0.5 years
Primary	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.	1 years
Primary	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.	1.5 years
Primary	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.	2 years
Secondary	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.	baseline
Secondary	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.	0.5 years
Secondary	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.	1 years
Secondary	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.	1.5 years
Secondary	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.	2 years
Secondary	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	baseline
Secondary	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	0.5 years
Secondary	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	1 years
Secondary	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	1.5 years
Secondary	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	2 years
Secondary	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.	baseline
Secondary	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.	0.5 years
Secondary	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.	1 years
Secondary	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.	1.5 years
Secondary	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.	2 years
Secondary	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	baseline
Secondary	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	0.5 years
Secondary	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	1 years
Secondary	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	1.5 years
Secondary	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	2 years
Secondary	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	baseline
Secondary	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	0.5 years
Secondary	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	1 year
Secondary	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	1.5 years
Secondary	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	2 years