Habilidades visoespaciales y afectivas en la enfermedad de Parkinson
Evaluación y rehabilitación de las capacidades visuoespaciales y afectivas en la enfermedad de Parkinson
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Messina
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Messina, Messina, Italia, 98124
- Laura Culicetto
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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. |
|
Experimental: 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. |
|
Comparador falso: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Improve visuospatial skills;
Periodo de tiempo: 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
|
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Modulate alexithymia;
Periodo de tiempo: 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;
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Improve the quality of life with PDQ-39 questionnaire
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Laura Culicetto, IRCCS Centro Neurolesi Bonino Pulejo
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Sinucleinopatías
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Síntomas de comportamiento
- Enfermedades neurodegenerativas
- Trastornos del movimiento
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Comportamiento
- Enfermedad de Parkinson
- Síntomas afectivos
- Fenómenos químicos
- Interacciones hidrofóbicas e hidrofílicas
- Propiedades superficiales
- Humectación
Otros números de identificación del estudio
- PRISM1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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