The Short-term Effects of Noninvasive Electrical Brain Stimulation on Dual Tasking in Older Adults
14 de marzo de 2022 actualizado por: Brad Manor, Hebrew SeniorLife
Optimization of Transcranial Direct Current Stimulation (tDCS) for Dual Task Performance in Older Adults With and Without a History of Falls
The tDCS & Dual Tasking study will compare the effects of transcranial Direct Current Stimulation (tDCS) targeting three different cortical regions (as well as sham stimulation) on dual task standing and walking in older adults with and without a recent history of recurrent falls.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The ability to stand and walk safely, especially while performing additional cognitive tasks like talking, reading or decision making, is critical to the preservation of functional independence into old age.
Such "dual tasking" often impairs balance, even in healthy older adults and those with greater dual task "costs" are more likely to suffer future falls.
Transcranial direct current stimulation (tDCS) is a safe, noninvasive and inexpensive means of modulating activity across cortical networks.
A single, 20-minute session of tDCS facilitates brain activity for up to 24 hours.
Through Dr. Manor's previous research in healthy older adults, he has discovered that just 20 minutes of tDCS targeting the left dorsolateral prefrontal cortex (dlPFC)-a region involved in both cognitive and motor function-immediately reduces the dual task costs to balance when standing and walking, and improves performance in the timed up-and-go (TUG) test of mobility.
However, there are several brain networks with known involvement in balance control and dual tasking, and the optimal brain region to target to improve dual task capacity has not been established.
The proposed study will be a double-blinded, sham-controlled study in which older adults both with and without a history of falling undergo dual task assessments immediately before and after single, 20-minute sessions of tDCS designed to target several different brain regions with known involvement in dual tasking and the maintenance of balance.
Tipo de estudio
Intervencionista
Inscripción (Actual)
61
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.
Ubicaciones de estudio
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Massachusetts
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Roslindale, Massachusetts, Estados Unidos, 02131
- Hebrew Rehabilitation Center
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Tel Aviv, Israel, 64239
- Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center
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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
65 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
"Faller" group
- Aged 65 years and older
- Able to read, write and communicate in English
- Self-report of 2 or more falls within the past 6 months
"Non-Faller" Group
- Aged 65 years and older
- Able to read, write, and communicate in English
- Self-report of 1 or no (zero) falls within the past 6 months
Exclusion Criteria:
- Self-reported diagnosis of Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, history of stroke or other neurodegenerative disorder.
- Self-reported active cancer for which chemo-/radiation therapy is being received.
- Hospitalization within the past 3 months due to acute illness or as a result of a musculoskeletal injury significantly affecting gait and balance.
- Montreal Cognitive Assessment score <18, or insufficient understanding of study procedures following review of the Informed Consent Form. Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
- Inability to stand or ambulate unassisted for at least 25 feet.
- Contraindications to tDCS, including a reported seizure within the past two years, use of neuro-active drugs, the risk of metal objects in the brain, skull, or head, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant), or the presence of any active dermatological condition, such as eczema, on the scalp (see appendix for standardized tDCS screening questionnaire).
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador falso: Sham Stimulation
The Sham stimulation intervention will consist of one, twenty-minute session of transcranial direct current stimulation (tDCS) that does not target a cortical area but instead, provides just enough current to create tingling sensations across the scalp to mimic the feeling of receiving the real stimulation.
The sham stimulation will use the same number and placement of electrodes as the real stimulation but with a much smaller total current intensity of 0.5 milliamps (mA).
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There will be three different tDCS targets as well as a sham stimulation condition.
The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
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Experimental: M1 Stimulation
The M1 stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the primary motor cortex at a total current intensity of 1.5 mA.
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There will be three different tDCS targets as well as a sham stimulation condition.
The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
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Experimental: DLPFC Stimulation
The DLPFC stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex at a total current intensity of 1.5 mA.
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There will be three different tDCS targets as well as a sham stimulation condition.
The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
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Experimental: M1+DLPFC Stimulation
The M1+DLPFC stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the primary motor cortex and the dorsolateral prefrontal cortex simultaneously at a total current intensity of 3.0 mA.
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There will be three different tDCS targets as well as a sham stimulation condition.
The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Dual task cost to standing postural sway speed
Periodo de tiempo: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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The dual task cost to standing postural sway speed will be calculated from trials of standing with and without simultaneous performance of a serial subtraction cognitive task.
The dual task cost will be calculated as the percent change in sway speed from single- to dual-task conditions.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Dual task cost to gait speed when walking
Periodo de tiempo: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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The dual task cost to gait speed when walking will be calculated from trials of walking with and without simultaneous performance of a serial subtraction cognitive task.
The dual task cost will be calculated as the percent change in gait speed from single- to dual-task conditions.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Dual task cost to postural sway area
Periodo de tiempo: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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The dual task cost to standing postural sway area will be calculated from trials of standing with and without simultaneous performance of a serial subtraction cognitive task.
The dual task cost will be calculated as the percent change in postural sway area from single- to dual-task conditions.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Dual task cost to gait variability when walking
Periodo de tiempo: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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The dual task cost to gait variability when walking will be calculated from trials of walking with and without simultaneous performance of a serial subtraction cognitive task.
Gait variability will be defined as the coefficient of variation about the average stride time (stride times defined by the time between consecutive heel strides of the same leg).
The dual task cost will be calculated as the percent change in gait variability from single- to dual-task conditions.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task postural sway speed
Periodo de tiempo: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task postural sway speed will be calculated from trials of standing without simultaneous performance of a serial subtraction cognitive task.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task postural sway area
Periodo de tiempo: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task postural sway area will be calculated from trials of standing without simultaneous performance of a serial subtraction cognitive task.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task gait speed variability when walking
Periodo de tiempo: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task gait variability when walking will be calculated from trials of walking without simultaneous performance of a serial subtraction cognitive task.
Gait variability will be defined as the coefficient of variation about the average stride time (stride times defined by the time between consecutive heel strides of the same leg).
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task gait speed when walking
Periodo de tiempo: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task gait speed when walking will be calculated from trials of walking without simultaneous performance of a serial subtraction cognitive task.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Mobility
Periodo de tiempo: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Mobility will be assessed using the Timed Up-and-Go test in which the amount of time it takes for the participant to stand up from a chair, walk three meters, turn around a cone, walk back, and sit down is recorded.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Executive function
Periodo de tiempo: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Executive function will be assessed using the Stroop test.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Cognitive processing speed
Periodo de tiempo: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Cognitive processing speed will be assessed using the Symbol Digit Modalities Test (SDMT).
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Attention
Periodo de tiempo: This outcome will be assessed immediately before and after each 20-minute session of tDCS
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Attention will be assessed using the Visual Search and Attention Test (VSAT).
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This outcome will be assessed immediately before and after each 20-minute session of tDCS
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Brad Manor, Institute for Aging Research, Hebrew SeniorLife
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 (Actual)
26 de mayo de 2017
Finalización primaria (Actual)
26 de noviembre de 2019
Finalización del estudio (Actual)
26 de mayo de 2021
Fechas de registro del estudio
Enviado por primera vez
15 de junio de 2017
Primero enviado que cumplió con los criterios de control de calidad
15 de junio de 2017
Publicado por primera vez (Actual)
19 de junio de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
14 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2016-26
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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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