파킨슨병의 시공간 및 정서적 능력
파킨슨병의 시공간 및 정서 능력 평가 및 재활
The aim of the study is to investigate whether prismatic adaptation (PA) and virtual prismatic adaptation (VPA), a non-invasive neuromodulation technique, that involves the use of lenses that deviate the visual field, can modulate alexithyima and performance in visuospatial tasks in patients with Parkinson disease. Furthermore, brain activity during the prismatic adaptation and post-adaptation phases will be recorded using functional near-infrared spectroscopy (fNIRS) and high-density electroencephalography (HD-EEG). Based on these premises, the present project aims to investigate the deficits of the affective, motor and visuospatial abilities in Parkinson's patients and the modulation of disorders through prismatic adaptation (PA) and virtual prism adaptation (VPA). Finally, we would like to evaluate production of the tear film and correlate their quantity with the severity of PD as it could be proposed as a new, non-invasive biomarker.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
Messina
-
Messina, Messina, 이탈리아, 98124
- Laura Culicetto
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Over 18 years old;
- Right-handed;
- Diagnosis of idiopathic Parkinson's disease according to the UK Brain Bank criteria (Lyon and Pahwa, 2011);
- Hoehn and Yahr Stadium (Hoehn and Yahr, 1996) <2,5;
- Stable pharmacological treatment (dopaminergic therapy: dopamine agonists and Levo-dopa) in the last 6 weeks.
Exclusion Criteria:
- - Sensory-motor deficits that can hinder neuropsychological assessment;
- Visual system disorders (blindness, glaucoma);
- Atypical parkinsonisms;
- PD with dementia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Right prismatic adaptation, right virtual primastic adaptation
Participants will undergo either right prismatic adaptation or right virtual prism adaptation, along with cognitive and motor assessments. |
Participants will fit with prismatic goggles that deviate their visual field by 13° either leftward or rightward. They will seat in front of a white horizontal board on which three target dots (5 mm diameter) were positioned at 0, -10 and +10° from their body midline at a distance of 57 cm from their eyes. They will perform a total of 150 verbally instructed pointing movements with their right index finger towards the right (+10°) and left (-10°) targets in a pseudorandom order. Tear film will be collected from the right and left eyes. |
|
실험적: Left prismatic adaptation, left virtual prismatic adaptation
Participants will undergo either left prismatic adaptation or left virtual prism adaptation, along with cognitive and motor assessments. |
Participants will fit with prismatic goggles that deviate their visual field by 13° either leftward or rightward. They will seat in front of a white horizontal board on which three target dots (5 mm diameter) were positioned at 0, -10 and +10° from their body midline at a distance of 57 cm from their eyes. They will perform a total of 150 verbally instructed pointing movements with their right index finger towards the right (+10°) and left (-10°) targets in a pseudorandom order. Tear film will be collected from the right and left eyes. |
|
가짜 비교기: Neutral prismatic adaptation, neutral virtual prismatic adaptation
Participants will undergo neutral prism adaptation or neutral virtual prism adaptation, along with cognitive and motor assessments. |
Participants will fit with prismatic goggles that deviate their visual field by 13° either leftward or rightward. They will seat in front of a white horizontal board on which three target dots (5 mm diameter) were positioned at 0, -10 and +10° from their body midline at a distance of 57 cm from their eyes. They will perform a total of 150 verbally instructed pointing movements with their right index finger towards the right (+10°) and left (-10°) targets in a pseudorandom order. Tear film will be collected from the right and left eyes. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Improve visuospatial skills;
기간: 2 years
|
Better performance in tests that evaluate visuospatial skills like line bisection test. The minimun value is 0 and the maximum is 3. Higher scores mean a worse outcome |
2 years
|
|
Modulate alexithymia;
기간: 2 years
|
improvement in tests evaluating alexithymia such as TAS-20. The TAS 20 has scores that have a minimum of 20 and a maximum of 100. Scores greater than or equal to 61indicate high levels of alexithymia |
2 years
|
|
Investigation of brain activity;
기간: 2 years
|
investigate the brain areas involved in the tasks with High Density Electroencephalography (EEG HD) and functional near infrared spectroscopy (fNIRS). The most active areas will be listed in a table |
2 years
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Improve the quality of life with PDQ-39 questionnaire
기간: 2 years
|
Promote rewarding experiences that improve self-esteem, the perceived sense of self-efficacy, the quality of life measured with the Parkinson's disease questionnaire (PDQ-39).The minimum score is 0 which indicates the best quality of life A maximum score is 100 which indicates the worst quality of life. |
2 years
|
|
Non invasive biomarker
기간: Until the end of the study
|
we would like to evaluate production of the tear film and correlate their quantity with the severity of PD as it could be proposed as a new, non-invasive biomarker. |
Until the end of the study
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Laura Culicetto, IRCCS Centro Neurolesi Bonino Pulejo
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- PRISM1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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