- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03441152
The Effects of Transcranial Direct Current Stimulation in Mild Cognitive Impairment
The Neural Effects of Multisession Transcranial Direct Current Stimulation in Older Adults at Risk for Mild Cognitive Impairment and Its Impact in Cognitive Functions and Everyday Memory: A Randomized Controlled Trial
Objectives: 1) To examine whether the real transcranial direct current stimulation (tDCS) group would perform better in the cognitive training (CT) intervention than the sham tDCS group and the CT group; 2) To determine if, as a consequence of the stimulation generated by the use of tDCS, there would be a transfer effect to other cognitive domains and to cognitive tasks in activities of daily living; 3) To investigate the time and spatial responses of tDCS on the brain cortex during and after tDCS application.
Hypothesis to be tested: By applying anodal tDCS with the combination of a CT delivered via the use of tablet PCs in older adults at risk of MCI, it will enhance their cognitive task performance in CT and subsequently generalize to other cognitive domains as well, involving a transferability to cognitive tasks in activities of daily living.
Design and subjects: A multi-centered single-blinded randomized controlled trial (RCT) with three groups (CT alone/Sham tDCS with the combination of a CT/ Real tDCS coupling with CT) The participants who will take part of this study will be older adults at risk of MCI Study instruments: tDCS, Ipad, Neuron Up CT Apps, EEG. Interventions: The intervention will last for 9 sessions (3 sessions per week for 3 weeks). Sham tDCS and real tDCS, will be combined with the same CT which is used in the CT group. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT.
Main outcome measures: Cognitive assessments, CT performance, EEG. In addition, delta and theta frequency suppression and alpha increment power under the anode electrode will be observed.
Descripción general del estudio
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Pablo Cruz Gonzalez
- Número de teléfono: +852 62382024
- Correo electrónico: pablo.cruzgonzalez@connect.polyu.hk
Copia de seguridad de contactos de estudio
- Nombre: Kenneth Fong
- Número de teléfono: +852 2766 6716
- Correo electrónico: rsnkfong@polyu.edu.hk
Ubicaciones de estudio
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Hong Kong, Hong Kong, Hung Hom
- Reclutamiento
- The Hong Kong Polytechnic University
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Contacto:
- Pablo Cruz Gonzalez
- Número de teléfono: +85262382024
- Correo electrónico: pablo.cruzgonzalez@connect.polyu.hk
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Contacto:
- Kenneth Fong
- Número de teléfono: +85227666716
- Correo electrónico: rsnkfong@polyu.edu.hk
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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:
The inclusion criteria will follow the modified Petersen's criteria:
- Aged between 60 and 85 years old;
- Obtaining a score on the Montreal Cognitive Assessment Test (MoCA) between 19 and 26;
- Achieving a score on the Clinical Dementia Rating (CDR) of 0.5 or below ;
- Self-reported cognitive decline by the participants themselves and
Being independent in daily living activities.
Additional criteria in this study include:
- Having completed three or more years of primary education;
- Ability to participate in a therapy session lasting at least 30 minutes;
- Community ambulant with or without aids; and
- Ability to perform a proper range of motion with hands in order to use a tablet PC.
Exclusion Criteria:
- 1) Individuals presenting with a diagnosis of dementia or any other neurological disease; (2) Individuals with depression determined by a score on Geriatric Depression Scale of >5, (3) History of drug or alcohol abuse or dependence in the last 3 months; and (4) Participants who had metallic fixtures around the cephalic area or skin lesions in the areas at where the electrodes were going to be attached were excluded from the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: tDCS+CT
application of tDCS in combination with CT
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Estimulación transcraneal de corriente continua
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Comparador falso: Sham tDCS
application of sham tDCS in combination with CT
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Estimulación transcraneal de corriente continua
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Comparador activo: CT
application of CT
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Estimulación transcraneal de corriente continua
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: 10 minutes
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It is a 30-point test about several cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) and a screening tool used of MCI and dementia.
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10 minutes
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Digit Span Test
Periodo de tiempo: 10 minutes
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The test measures short term memory in such a way that sequences of digits are presented and have to be recalled in forward and reverse order.
Testing ends when the maximal list length is reached or when subjects fail to recall the trial at one sequence length.
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10 minutes
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Trial Making Test (TMT)
Periodo de tiempo: 5 minutes
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TMT encompasses visual attention and processing speed, it consists of 2 parts in which a set of 25 dots in the first part and 24 dots in the second part have to be accurately connected.
Time performance is measured as the main outcome
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5 minutes
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Riverhead Behavioral Memory Test (3rd edition) (RBMT-3)
Periodo de tiempo: 40 minutes
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It includes 14 subtests assessing aspects of visual, verbal, recall, recognition, immediate and delayed everyday memory.
Additionally prospective memory skills and the ability to learn new information are measured as well
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40 minutes
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cognitive training activities ( Neuronup cognitive training)
Periodo de tiempo: 30 minutes each session ( 9 sessions in total)
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Performance of the cognitive training activities conducted every session
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30 minutes each session ( 9 sessions in total)
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EEG
Periodo de tiempo: 15 minutes
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time and spatial responses of tDCS on the brain cortex before and after tDCS application
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15 minutes
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HongKongPUPabloRS
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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