Chinese DENOVO PD Registry

Condition(s) studied

Study summary

The main objective of this longitudinal, multi-center study is to explore the clinical characteristics of PD and confirm biomarkers for PD evolution or progression.

Eligibility

Primary outcome measure(s)

• The Unified Parkinson's Disease Rating Scale for evaluating motor subtypes — from baseline to 10 years
  The UPDRS is made up of four parts, 55 items in total. Total score varies from 0 to 199. Part I: evaluation of behavior and mood, which consists of 4 items, score varies from 0-16; Part II: self-evaluation of the activities of daily life, which consists of 13 items,score varies from 0-52; Part III: motor evaluation, which consists of 27 items, score varies from 0-108; Part IV: complications of therapy, which consists of 11 items,score varies from 0-23. All the patients are evaluated in "OFF" state. The ratio of the mean tremor score (scores of item-16, item-20, and item-21 will be added: ) to the mean postural instability/gait disorder (PIGD) score (scores of item-13, item-14, item-15, item-29, item-30 will be added: ) was used to classify motor subtype. Patients with a ratio value \< 1.0 were defined as PIGD, and those with values from 1.0 to 1.5 were categorized as intermediate, while those with values ≥1.5 were classified as tremor dominant.
• The clinical stage of PD is assessed by Hoehn and Yahr scale — from baseline to 10 years
  The H-Y scale ranges from 1 to 5. Early PD is defined as H-Y stage 1 to 2.5, advanced PD is defined as H-Y stage 3-5.
• The non-motor symptoms are evaluated by Non-motor Symptom Scale — from baseline to 10 years
  This scale includes 30 items which is divided into 9 domains. Total score varies from 0-360. Higher score indicates severer symptoms. Domain 1 evaluates cardiovascular system symptoms. Score of domain 1 varies from 0-24. Domain 2 evaluates sleep condition. Score of domain 2 varies from 0-48. Domain 3 evaluates cognitive function. Score of domain 3 varies from 0-72. Domain 4 evaluates illusion. Score of domain 4 varies from 0-36. Domain 5 evaluates attention and memory. Score of domain 5 varies from 0-36. Domain 6 evaluates gastrointestinal symptoms. Score of domain 6 varies from 0-36. Domain 7 evaluates urinary symptoms. Score of domain 7 varies from 0-36. Domain 8 evaluate sensory symptoms. Score of domain 8 varies from 0-24. Domain 9 evaluates other non-motor symptoms. Score of domain 9 varies from 0-48.
• Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome III — from baseline to 10 years
  The diagnostic criteria must include two or more of the following 1. Straining during at least 25% of defecations 2. Lumpy or hard stools in at least 25% of defecations 3. Sensation of incomplete evacuation for at least 25% of defecations 4. Sensation of anorectal obstruction/blockage for at least 25% of defecations 5. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)f. Fewer than three defecations per week 2. Loose stools are rarely present without the use of laxatives 3. Insufficient criteria for irritable bowel syndrome \* Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
• The PDQ-39 was used to assess the quality of life — from baseline to 10 years
  This scale includes 39 items assessing the following regions: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communications (3 items) and bodily discomfort (3 items). Alternatively, the sum of the scores can assess the overall health-related quality of life profile of the individual questioned. Scores in each region should be added. The score of the answers ranges from 0 to 4 for each item and the total score ranges from 0 to 116, where higher scores reflect worse life quality
• Sleep quality is evaluated by Parkinson's Disease Sleep Scale — from baseline to 10 years
  This scale includes 15 items that address eight aspects of sleep disturbances in PD, including overall quality of night's sleep (item 1)), score of item 1 less than 6 is defined as sleep disorder. Score of all the questions will be summed. The score of the answers ranges from 0 to 10 for each item and the total score ranges from 0 to 150, where higher scores reflect better sleep condition.
• Epworth Sleepiness Scale evaluates excessive sleepiness — from baseline to 10 years
  This scale includes 8 items. Score of all the questions will be summed. All items were rated on a 4-point scale (0- 3), with a minimal score of 0, and maximum total score of 24. A higher score demonstrates more severe excessive daytime sleepiness. Participants were classified as showing excessive daytime sleepiness if their total score ≥10 .
• Probable rapid eye movement sleep behavior disorder was diagnosed by Probable rapid eye movement sleep behavior disorder Questionnaire -Hongkong — from baseline to 10 years
  This scale includes 13 items. Score of all the questions will be summed. Total score of the answers ranges from 0 to 100, where higher scores reflect severer rapid eye movement sleep behavior disorder.The optimal cutoff value for the overall scale is 17; subjects were classified as showing RBD when they reached the above score.
• Olfaction test was measured by Hyposmia Rating Scale — from baseline to 10 years
  This scale includes 6 items. Score of all the questions will be summed. All items were rated on a 4-point scale (1-4), with a minimal score of 6, and maximum total score of 24. A higher score demonstrates more worse sense of olfaction. The cutoff value HRS is 22.5.
• Cognitive condition is assessed by Mini Mental State Examination — from baseline to 10 years
  This scale includes 30 items. Score of all the questions will be summed. All items were rated on a 2-point scale (0- 1), with a minimal score of 0, and maximum total score of 30. A higher score demonstrates more better cognitive condition. The definition of cognitive disorder differs in education level. For illiteracy, presence of cognitive impairment is defined as MMSE score. For those only receive elementary education, the cut-off value is 20. For other patients, presence of cognitive impairment was defined as MMSE scores less than 25.
• Depression was diagnosed by Hamilton and Montgomery-Asberg Depression Scale — from baseline to 10 years
  This scale includes 17 items. Score of all the questions will be summed. Total score ranges from0-53. A higher score demonstrates more severer depression. The study participants were defined to be not depressed (scores 0-6) , to have minor depression(scores 7-14), or to have major depression (scores above 14) at the different visits during follow-up.
• Autonomic symptoms are evaluated by The Scale for outcomes in Parkinson disease for Autonomic Symptoms — from baseline to 10 years
  This scale includes 25 items assessing the following regions: gastrointestinal (7 items), urinary (6 items), cardiovascular (3 items), thermoregulatory (4 items), pupillomotor (1 items), and sexual dysfunction(2 items for men and 2 items for women). Scores in each region should be added. The score of the answers ranges from 0 to 3 for each item and the total score ranges from 0 to 69, where higher scores reflect worse autonomic functioning.
• Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire — from baseline to 10 years
  1. have, or have you had, recurrent uncomfortable feelings or sensations in your legs while you are sitting or lying down 2. have, or have you had, a recurrent need or urge to move your legs while you were sitting or lying down 3. more likely to have these feelings when you are resting 4. If you get up or move around when you have these feelings, these feelings get better 5. these feelings in your legs most likely to occur at mid-day or afternoon or evening or night 6. Simply changing leg position by itself once without continuing to move usually relieve these feelings usually don't relieves 7. These feelings are not or not always due to muscle cramps
• Symptom of fatigue was measured by PD fatigue severity scale — from baseline to 10 years
  This scale includes 9 items. Score of all the questions will be summed. All items were rated on a 7-point scale (1-7). Total score ranges from0-63. A higher score demonstrates more severer fatigue.
• Freezing gait by new freezing gait questionnaire scores — from baseline to 10 years
  Parts II and III provides a total summed score between 0 and 28. Part II (items 2-6, scoring range 0-19) rated the severity of FOG based on its duration and frequency in its most common manifestation. Total score will be calculated for comparison.
• Dyskinesia was evaluated by UPDRS part III — from baseline to 10 years
  The presence of dyskinesia is evaluated by the doctor and recordsed.

Trial sites (1)

More Xiangya Hospital of Central South University trials in China

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