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The Effect of tDCS on a Motor-cognitive Dual-task Performance of Parkinson's Patients

19 de julio de 2015 actualizado por: michal roll, Tel-Aviv Sourasky Medical Center

The Effect of Transcranial Direct Cortical Stimulation (tDCS) on a Motor-cognitive Dual-task Performance of Parkinson's Patients

The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous every day phenomena. For example, people frequently walk while talking on a cellphone or drive while talking to a passenger. Often, the performance of one or more of these simultaneously performed tasks may deteriorate when another task is carried out at the same time, even in healthy young adults. This reduction in performance is referred to as the DT deficit or DT cost and is typically much higher in patients with Parkinson's disease (PD) than in young adults or age-matched controls. In PD, this DT cost impairs the gait pattern, as manifested, for example, in increased gait variability, exacerbating instability and fall risk.

In the proposed study, would be evaluated the effects of tDCS on dual tasking performance following tDCS.

The researchers expect that stimulation of the Pre Frontal Cortex (PFC) (using tDCS) will increase DT performance and prefrontal activation.

Descripción general del estudio

Estado

Desconocido

Descripción detallada

tDCS intervention: Noninvasive tDCS will be delivered by study personnel uninvolved with any other study procedures. In the study will be used a battery-driven electrical stimulator. Stimulation and sham condition will be performed based on previous studies. Briefly, the anode will be placed over the PFC and the cathode over the right supraorbital region. The real tDCS condition will consist of 20 min of continuous stimulation at target intensity of 1.5 mA. This amount of stimulation is safe for healthy young and older adults and has been shown to induce acute beneficial changes in cortical excitability and cognitive functions. For the sham condition, an inactive stimulation protocol would be followed, as compared with an 'off-target' active protocol, in order to minimize participant risk. After each session, subjects will complete a side effects questionnaire. The efficacy of tDCS blinding will also be assessed after the final session, by asking each subject to judge whether they received real or sham tDCS, as well as their certainty of this judgment. Pre- and post-tDCS assessments will include:

fMRI: All of the MR images will be acquired on a 3.0 T scanner using an 8-channel head coil. T1-weighted brain volume (BRAVO) acquisitions will evaluate gray matter (GM) volume and thickness, markers of brain atrophy. This sequence will measure the ratio of GM within the PFC to overall GM, which will then be used to quantify the level of activation within the PFC. T2* echo planner imaging acquisition will be used for all the DT paradigms including intrinsic functional connectivity. Intrinsic connectivity will be examined while subjects are not engaged in any particular task and are requested to lie still with their eyes open (i.e., resting state). To examine task related changes versus more generalized patterns of DT activations, the type of the cognitive task or the nature of the motor task will be different in each task. The researchers will specifically examine the contribution of a secondary task involving working memory (arithmetic processing vs. attention), conflict monitoring, and motor planning on DT related activations.

fNIRS : fNIRS will be used to investigate the role of the frontal lobe in DT walking and how it is affected by tDCS [Mirelman et al. 2014]. The fNIRS system (Oxymon MKIII; Artinis Medical Systems) consists of flexible circuit board that carries the near-infrared light sources and detectors. The fNIRS sources and detectors pairs will be placed over the left (Fp1) and right (Fp2) frontal cortex regions of the forehead, as previously reported.

Gait assessment: Gait parameters will include both spatial and temporal parameters obtained using body fixed wearable sensors (accelerometers and gyroscopes) [Weiss et al. 2015;Ben et al. 2015]. Parameters will include (but are not limited to) gait speed, stride length and stride time as well as rhythmicity measures such as stride to stride variability and gait regularity.

The UPDRS, fall history and fear of falling will also be assessed (e.g., Falls Efficacy Scale International, FES-I) to further characterize the cohort and explore possible confounds.

Cognitive assessment: A detailed computerized cognitive battery that has been used extensively at TASMC in PD and other cohorts [Dwolatzky et al. 2003;Hausdorff et al. 2006;Springer et al. 2006;Yogev et al. 2005;Aarsland et al. 2003] will quantify several cognitive domains including working memory, executive function, verbal function, problem solving, a global cognitive score, and attention.

Sample size: Based on the effects of tDCS on DT walking outcomes in other cohorts [Leite et al. 2014;Zhou et al. 2014], the research group consider a conservative change of 15% in HbO2 levels after tDCS, as compared to sham, 18 subjects per group will provide >80% power. In order to allow for potential inter-subject variability and to address secondary questions (e.g., effect of disease severity), would be to assess 30 participants in each group.

Data collection:

A research assistant will assist participants filling in the electronic questionnaires and will conduct the non electronic ones (these would be later transcribed to excel sheets by research assistants).

A post-doc fellow and a PhD student will run the MRI scans and the tDCS sessions together with one-two research assistants. The participants will receive a reminder (by phone and or email) one day prior to each session. Participation will be monitored by the research assistants.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Anat Mirelman, PhD
  • Número de teléfono: 972-3-6974958
  • Correo electrónico: anatmi@tlvmc.gov.il

Copia de seguridad de contactos de estudio

  • Nombre: Jeffery M Hausdorff, PhD
  • Número de teléfono: 972-3-6974958
  • Correo electrónico: jhausdor@tlvmc.gov.il

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Diagnosis of idiopathic PD (defined by the UK Brain Bank criteria)
  2. Hoehn and Yahr score between 1.5-3
  3. Taking anti-parkinsonian medications.

Exclusion Criteria:

  1. Mini Mental State Exam (MMSE) score =< 24
  2. Brain surgery in the past including implanted DBS
  3. Major depression (DSM-IV Criteria)
  4. Cerebral Infarction with Residual Deficits Diagnosis
  5. Neurological diseases (except from PD)
  6. Orthopaedic or cardiovascular diseases that may affect walking and cognitive abilities.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Active tDCS
The active tDCS condition will consist of 20 min of continuous stimulation. This amount of stimulation is safe for healthy young and older adults and has been shown to induce acute beneficial changes in cortical excitability and cognitive functions.
In this group subjects will receive 20 min of treatment.
Otros nombres:
  • Estimulación de corriente continua transcraneal
Comparador falso: Sham tDCS
The Sham tDCS - an inactive stimulation.
In this group subjects will receive 20 min of sham stimulation.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cambios en la frecuencia y severidad del fenómeno de congelamiento de la marcha
Periodo de tiempo: Una semana después de la intervención
La nueva versión del cuestionario Freezing of Gait se utilizará para cuantificar la frecuencia y gravedad de este síntoma. La puntuación se comparará con la línea de base.
Una semana después de la intervención

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
fMRI scans - changes in gray matter (GM) volume
Periodo de tiempo: One week post intervention
All of the MR images will evaluate gray matter (GM) volume, markers of brain atrophy.
One week post intervention
fNIRS related frontal lobe activation - changes in tissue oxygenation
Periodo de tiempo: One week post intervention
fNIRS will be used to investigate the role of the frontal lobe in DT walking and how it is affected by tDCS.The fNIR system provides with real-time monitoring of tissue oxygenation in the brain as subjects take different tests.
One week post intervention
Changes in cognitive performance
Periodo de tiempo: One week post intervention
The NeuroTrax software uses tests of cognitive performance that measure similar cognitive functions to traditional paper-based tests.
One week post intervention
Immediate change in gait speed
Periodo de tiempo: One week post intervention
Gait speed will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.
One week post intervention
Immediate change in gait variability
Periodo de tiempo: One week post intervention
Gait variability will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.
One week post intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Investigador principal: Nir Giladi, M.D, Tel Aviv Sourasky medical Center, Tel Aviv, Israel. Phone: 972-3-6974790

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2015

Finalización primaria (Anticipado)

1 de julio de 2018

Finalización del estudio (Anticipado)

1 de octubre de 2018

Fechas de registro del estudio

Enviado por primera vez

9 de julio de 2015

Primero enviado que cumplió con los criterios de control de calidad

19 de julio de 2015

Publicado por primera vez (Estimar)

21 de julio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

21 de julio de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

19 de julio de 2015

Última verificación

1 de julio de 2015

Más información

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. .

Ensayos clínicos sobre Enfermedad de Parkinson

Ensayos clínicos sobre Active tDCS

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