Estimulación para mejorar la memoria (STIM)
Prueba de estimulación de corriente continua transcraneal de alta definición (HD-tDCS) como tratamiento del deterioro cognitivo leve
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48105
- University Of Michigan
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
- Diagnóstico de Deterioro Cognitivo Leve (DCL) o demencia tipo Alzheimer (DAT)
- Debe ser compatible con IRM, criterios que también se aplican a la estimulación de corriente directa transcraneal de alta definición (HD-tDCS; p. ej., ausencia de implantes metálicos o electrónicos en la parte superior del cuerpo o la cabeza)
- Estable con medicamentos relevantes durante al menos 4 semanas antes de la inscripción en el estudio
Criterio de exclusión:
- Ciertas enfermedades neurológicas
- Ciertas condiciones psiquiátricas
- Deterioro sensorial severo
Plan de estudios
¿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 |
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Comparador falso: Estimulación simulada
Dosis simulada (placebo) del tratamiento HD-tDCS durante 30 minutos, entre 5 y 30 sesiones.
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Los participantes recibirán HD-tDCS simulada (placebo) durante 30 minutos, entre 5 y 30 sesiones.
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Experimental: Estimulación de dosificación de 1 mA
Dosis de 1 miliamperio de tratamiento HD-tDCS durante 30 minutos, entre 5-30 sesiones.
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Los participantes recibirán HD-tDCS a 1 mA durante 30 minutos, entre 5 y 30 sesiones.
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Experimental: Estimulación de dosificación de 2 mA
Dosis de 2 miliamperios de tratamiento HD-tDCS durante 30 minutos, entre 5-30 sesiones.
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Los participantes recibirán HD-tDCS a 2 mA durante 30 minutos, entre 5 y 30 sesiones.
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Experimental: Estimulación de dosificación de 3 mA
Dosis de 3 miliamperios de tratamiento HD-tDCS durante 30 minutos, entre 5-30 sesiones.
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Los participantes recibirán HD-tDCS a 3 mA durante 30 minutos, entre 5 y 30 sesiones.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Lateral Temporal Cortex Connectivity
Periodo de tiempo: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Primary outcome focuses on default mode network (DMN) between-network functional connectivity because the lateral temporal cortex is a core component of the DMN.
Between-network functional connectivity is estimated from fMRI data as strength of temporal coupling between the DMN and other high-level (association) brain networks.
For each participant and time point, correlation-based connectivity (Pearson r; Fisher r-to-z transformed; arbitrary units) computed between DMN regions and other regions of the association cortex defined using standard functional atlas.
Higher values reflect stronger functional connectivity between DMN and other regions.
A Z-score's range is infinite.
Expected value is between -3 to 3. Analyses conducted separately for amyloid negative (A-) and amyloid positive (A+) participants.
Post Intervention data collection was on day 5 of treatment.
Post-Expansion (PE) appointments were not consecutive.
Mean time between enrollment and PE was 10 wks, longest was 43 wks.
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Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Self-Report of Contentment With Memory
Periodo de tiempo: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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The Multifactorial Memory Questionnaire (MMQ) consists of three scales measuring separate aspects of metamemory. Items are rated on a 5-point Likert scale (0-4) based on the test taker's experiences over the previous two weeks. MMQ-Satisfaction (formerly called MMQ-Contentment) scale measures satisfaction, concern, and overall appraisal of one's own memory. Each of 18 statements is rated based on degree of agreement. The score range is 0 to 72, with higher scores indicating a higher degree of satisfaction. Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks. |
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Self-Report of Memory Mistakes
Periodo de tiempo: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Multifactorial Memory Questionnaire (MMQ) Ability Score - This scale measures self-perception of everyday memory ability. Respondents rate how often they experienced each of 20 common memory mistakes over the previous two weeks. The score range is 0 to 80, with higher scores indicating better self-reported memory ability. Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks. |
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Self-Report of Memory Strategies Used
Periodo de tiempo: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Multifactorial Memory Questionnaire (MMQ) Strategies Score - This scale measures the use of practical memory strategies and aids in day-to-day life. Respondents rate how often they used each of 19 memory strategies over the previous two weeks. The score range is 0 to 76, with higher scores indicating greater use of memory strategies. Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks. |
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Change in Memory Functioning
Periodo de tiempo: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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The Repeatable Battery of the Assessment of Neuropsychological Status (RBANS) is a comprehensive neuropsychological battery for the evaluation of global cognition.
The delayed memory section is a measure of delayed recall and recognition for verbal and visual information.
It includes the subtests List Recall, List Recognition, Story Memory, and Figure Recall.
Low scores on this index indicate difficulties with recognition and retrieval of information from long-term memory stores This index is composed of both auditory and visual measures; therefore, a severe deficit in language, auditory processing, or visual functioning may impact one of the measures more than the other.
Analysis included the sum of the raw scores for each of the delayed memory subtests, with possible scores ranging from 0 to 62. Post Intervention data collection was on day 5 of treatment.
Post-Expansion (PE) appointments were not consecutive.
Mean time between enrollment and PE was 10 wks, longest was 43 wks.
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Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Change in Overall Fluid Cognitive Abilities
Periodo de tiempo: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Cognitive function was determined using the NIH Toolbox-Cognition Battery computerized tests, specifically the Fluid composite score. It is derived by averaging the subtests in the Fluid domain to achieve an overall standard score. Fully Corrected T-scores are adjusted for for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in the NIH Toolbox nationally representative normative sampling. The T-score has a mean of 50 in the general population and a SD of 10. Scores higher than the mean indicate better performance. Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks. |
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Cumulative Working Memory Effects of HD-tDCS Across Treatment Sessions
Periodo de tiempo: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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The n-back test is a working memory task where participants identify stimulus that matches stimulus experienced "n" steps back. Participants performed a 2-back test, in which they were asked to remember and press a button when shown a stimulus that appeared 2 steps before the current one (e.g. square, circle, square). The number of correct and incorrect identifications are normalized (z-score). Total score is the z-score of correct button presses minus the z-score of incorrect button presses. A higher score (d') reflects better working memory performance. Possible scores range from -4.85 to 4.85. Positive change (increase) in 2-back score across treatment sessions indicates improvement in working memory performance. Data is shown as the mean slope calculation of participants across first 5 days of treatment and across all treatments, x=days of treatment, y=n-back score. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks. |
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Cumulative Memory Accuracy Effects of HD-tDCS Across Treatment Sessions
Periodo de tiempo: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Paired Associates task is a verbal memory task that asks participants to learn a list of word pairs. After a delay, participants are shown correct and mismatched word pairs one at a time and asked to identify if the displayed word pair was from the list they were asked to learn or not. Total accuracy is a proportion (total correct responses divided by total trials completed) ranging from 0 to 1 that measures the accuracy of a participant's responses to both correct and mismatched word pairs. Higher scores indicate better verbal memory performance, and positive changes over time indicate an improvement in verbal memory performance, measured after baseline (Session 1) and every intervention session (Sessions 2-5) Data is shown as the mean slope calculation of participants across first 5 days of treatment and across all treatments, x=days of treatment, y= total accuracy. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks. |
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Cumulative Memory Sensitivity Effects of HD-tDCS Across Daily Sessions
Periodo de tiempo: Baseline
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Verbal memory performance for computerized Paired Associates task, summarized with a computational model (linear ballistic accumulator decision model).
The model uses each participant's accuracy and reaction times across trials to estimate how efficiently they accumulate information to distinguish previously studied (target) word pairs from new (lure) pairs.
Reported outcome is the average memory sensitivity score at baseline, expressed as unitless model values (scores on a scale) where higher scores indicate better discrimination, scores near zero indicate chance-level performance, and negative scores (if present) indicate performance worse than chance.
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Baseline
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Tolerability of HD-tDCS
Periodo de tiempo: Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks); values represent mean symptom burden averaged across all post-stimulation assessments
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Tolerability was assessed using the HD-tDCS Safety Questionnaire, an 11-item symptom checklist.
The questionnaire assesses the presence (yes/no) of 10 specific self-reported symptoms (Itching, Burning, Tingling, Scalp Pain, Trouble Concentrating, Sleep problems, Headache, Mood Change, Neck Pain, and Other symptoms) and 1 oberserved symptom, Skin Redness.
Skin Redness was excluded from this analysis as it is not related to the participant's perception of tolerability.
The total score (symptom burden) was calculated by summing the number of symptoms present across the 10 items for each session.
Score range: 0 to 10 symptoms, where 0 = no symptoms present and 10 = all symptoms present.
Higher scores indicate worse tolerability (more symptoms experienced).
Values represent the mean number of symptoms per session, calculated by averaging symptom burden scores across all post-stimulation assessments within each treatment group.
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Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks); values represent mean symptom burden averaged across all post-stimulation assessments
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Effectiveness of Blinding of HD-tDCS
Periodo de tiempo: Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks)
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Participant's perception of treatment assignment assessed after each stimulation session using a 3-category ordinal scale.
Participants guessed whether they received: (0) Sham stimulation, (1) Don't Know, or (2) Active stimulation.
The scale is ordinal with Sham < Don't Know < Active.
Effective blinding is indicated by no significant difference in the distribution of perceived assignment between active and sham groups (i.e., participants in active groups cannot reliably distinguish their treatment from sham).
Higher proportional odds ratios would indicate active group participants were more likely to guess "active"; lower ratios would indicate sham participants were more likely to guess "active" (paradoxical pattern suggesting convincing sham condition).
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Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks)
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Change in Default Mode Network Connectivity
Periodo de tiempo: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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The outcome focuses on default mode network (DMN) within-network functional connectivity. Within-network functional connectivity is estimated from fMRI data as strength of temporal coupling within DMN regions (nodes). For each participant and time point, correlation-based connectivity (Pearson r; Fisher r-to-z transformed; arbitrary units) was computed between DMN regions defined using a standard functional atlas. Higher values reflect stronger functional connectivity within DMN. A Z-score's range is infinite. Expected value is around -3 to 3. Analyses are conducted separately for amyloid negative (A-) and amyloid positive (A+) participants. Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks. |
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Cumulative Cognitive Change Across Daily Consecutive Sessions
Periodo de tiempo: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Measured through change in Cogstate or other comparable computerized cognitive testing scores across consecutive daily sessions.
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Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Change in Global Cognition
Periodo de tiempo: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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The Repeatable Battery of the Assessment of Neuropsychological Status (RBANS) is a comprehensive neuropsychological battery for the evaluation of global cognition and has been validated in subjects with mild cognitive impairment, moderate to severe traumatic brain injuries, vascular dementias, and Alzheimer's disease. Data was analyzed using the sum of the subtest raw scores, which is an indicator of the general cognitive functioning of the examinee. Low scores suggest general cognitive impairment even when some individual subtest scores may be within normal limits. Individuals with low scores on this measure exhibit problems with attention, memory, language, and construction skills. Possible scores range from 0 to 321. Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks. |
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cambio en la capacidad de inhibición
Periodo de tiempo: Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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La intención a priori de medir a través del cambio en el NIH Toolbox Flanker Control inhibitorio y puntuación de la prueba de atención
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Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Cambio en la capacidad de conceptualización
Periodo de tiempo: Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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La intención a priori de medir a través del cambio en el NIH Toolbox Dimensional Change Card Sort Test Score
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Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Cambio en la memoria de secuencia de imágenes
Periodo de tiempo: Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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La intención a priori de medir a través del cambio en la puntuación de la prueba de memoria de secuencia de imágenes de la caja de herramientas de NIH
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Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Cambio en la capacidad de la memoria de trabajo
Periodo de tiempo: Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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La intención a priori de medir a través del cambio en la lista de la caja de herramientas de los NIH Ordenar la puntuación de la prueba de memoria de trabajo
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Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Cambio en la velocidad de procesamiento
Periodo de tiempo: Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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La intención a priori de medir a través del cambio en el NIH Toolbox Pattern Comparison Processing Speed Test Score
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Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Cambio en el funcionamiento visuoespacial
Periodo de tiempo: Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Medido a través del cambio en la puntuación del índice visuoespacial RBANS
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Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Cambio en el funcionamiento del lenguaje
Periodo de tiempo: Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Medido a través del cambio en la puntuación del índice de idioma RBANS
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Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Cambio en la atención
Periodo de tiempo: Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Medido a través del cambio en la puntuación del índice de atención de RBANS
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Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Cambio en el funcionamiento de la memoria
Periodo de tiempo: Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Medido a través del cambio en la puntuación del índice de memoria inmediata de RBANS
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Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Cambio en el funcionamiento cognitivo
Periodo de tiempo: Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Intención a priori de medir a través de cambios en las puntuaciones de las subpruebas RBANS
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Línea de base y post-intervención (después de las sesiones 5 y 30 de tDCS)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Benjamin Hampstead, PhD, Associate professor
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- HUM00146180
- 1R01AG058724 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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