Chinese FMDs Registry

NCT05201521 | Unknown DMC

• 1 other identifier: SN-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Movement Disorders

Outcome Measures

Primary Outcomes (13)

• The symptom characteristics

  Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.

  baseline

• The symptom characteristics

  Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.

  0.5 years

• The symptom characteristics

  Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.

  1.5 years

• The symptom characteristics

  Symptom characteristics such as tremor, type of dystonia, Parkinson's like symptoms, myoclonus, etc.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  2 years

Secondary Outcomes (25)

• Hamilton Depression Scale

  baseline

• Hamilton Depression Scale

  0.5 years

• Hamilton Depression Scale

  1 years

• Hamilton Depression Scale

  1.5 years

• Hamilton Depression Scale

  2 years

Other Outcomes (1)

• The symptom characteristics

  1 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

At least 100 patents coming from hospitals or communities in mainland China

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Gang Wang, MD,PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Wang, MD,PhD

CONTACT

086-021-64370045; wg11424@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 21, 2022
• Study Start: January 27, 2022
• Primary Completion: August 31, 2023
• Study Completion: January 27, 2024
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)