- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03076307
DAT SPECT and Procedural Motor Skills in Parkinson's Disease
Correlation of Procedural Motor Skills Impairment and 123I-FP-CIT SPECT Uptake in Patients With Early Parkinson's Disease: a Case-control Study
Patients with Parkinson's disease (PD) are known to be affected by subtle cognitive impairment early in the disease course, mostly in the executive field. Procedural motor skills, mainly controlled by the basal ganglia associative loop (in particular dorsal caudate nucleus) (Rodriguez-Oroz et al., 2009), have also been studied in patients with PD (Schnider et al., 1995; Muslimovic et al., 2007; Terpening et al., 2013). However, the correlation of dopaminergic 123I-FP-CIT SPECT imaging and cognitive impairment has not been assessed. One reason is the absence of reference values for striatal uptake until recently. Last year, the investigators established local uptake reference values for DAT imaging based on a large cohort of subjects with non-degenerative conditions (Nicastro et al., 2016) and can therefore use these values to precisely assess uptake loss in patients with PD.
With the present study, the investigators expect to enroll patients with early PD for whom a 123I-FP-CIT SPECT has been previously performed in the center. Subjects will perform a specific motor task based on mirror-drawing of star-shaped figures. This will be done by inverting the direction of horizontal/vertical computer mouse movements on the screen. Speed and error rates will be assessed for patients as well as healthy control subjects. Correlation with striatal SPECT uptake, especially caudate nucleus uptake, will be analyzed for PD patients. In addition, resting-state EEG will be performed for all subjects. General medication and dopaminergic drugs in particular, whenever used, will not be discontinued. For all subjects enrolled in the study, cognitive and neurological examination will be performed.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Geneva, 스위스, 1206
- Division of Neurorehabilitation, Geneva University Hospitals
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria for PD group:
- Age > 18 year-old
- Diagnosis of PD with onset <2 years from enrollment
- Available DAT SPECT performed in Geneva University Hospitals <6 months before inclusion
Inclusion criteria for control group:
Age- and sex-matched control patients
- Age > 18 year-old
- No known neurological condition interfering with motor and cognitive abilities
- No medication interfering with central nervous system (including antidepressants, antipsychotics, hypnotics)
Exclusion criteria for both groups:
- Major depressive state (Hospital Anxiety and Depression scale ≥11 for depression score)
- Cognitive decline (Mini-Mental Score ≤ 22/30)
- Debilitating tremor (Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III - rest, postural and action tremor ≥2/4)
- Significant akinesia (MDS-UPDRS III hand brady-akinesia score ≥2/4)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 대조군
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Evaluation of error rate and speed for completion of a procedural motor task
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실험적: Parkinson's disease
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Evaluation of error rate and speed for completion of a procedural motor task
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Procedural motor performance (error and time) in PD group
기간: 2 days
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Evaluation of error rate and speed for completion of mirror-drawing of star-shaped figures
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2 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Resting state EEG connectivity in PD and control groups
기간: 2 days
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Evaluation of resting state EEG connectivity in both groups
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2 days
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Difference >20% in error rate and speed improvement in control and PD groups
기간: 2 days
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Evaluation of a >20%-difference between PD and control groups in terms of speed and error rate for the successive procedural motor task trials
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2 days
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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