Stymulacja poprawiająca pamięć (STIM)
Testowanie przezczaszkowej bezpośredniej stymulacji prądem o wysokiej rozdzielczości (HD-tDCS) jako leczenia łagodnych zaburzeń poznawczych
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48105
- University of Michigan
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Opis
Kryteria przyjęcia:
- Diagnoza łagodnych zaburzeń poznawczych (MCI) lub otępienia typu Alzheimera (DAT)
- Musi być kompatybilny z MRI, kryteria, które dotyczą również przezczaszkowej stymulacji prądem stałym w wysokiej rozdzielczości (HD-tDCS; np. brak metalowych lub elektronicznych implantów w górnej części ciała lub głowie)
- Stabilny na odpowiednich lekach przez co najmniej 4 tygodnie przed włączeniem do badania
Kryteria wyłączenia:
- Niektóre choroby neurologiczne
- Niektóre stany psychiczne
- Ciężkie upośledzenie czucia
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Pozorny komparator: Pozorowana stymulacja
Pozorowana (placebo) dawka leczenia HD-tDCS przez 30 minut, przez 5-30 sesji.
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Uczestnicy otrzymają pozorowaną (placebo) HD-tDCS przez 30 minut, przez 5-30 sesji.
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Eksperymentalny: Stymulacja dawki 1 mA
Dawka 1 miliampera HD-tDCS przez 30 minut, przez 5-30 sesji.
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Uczestnicy otrzymają HD-tDCS przy 1 mA przez 30 minut, przez 5-30 sesji.
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Eksperymentalny: Stymulacja dawki 2 mA
Dawka 2 miliamperów HD-tDCS przez 30 minut, przez 5-30 sesji.
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Uczestnicy otrzymają HD-tDCS przy 2 mA przez 30 minut, przez 5-30 sesji.
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Eksperymentalny: Stymulacja dawki 3 mA
Dawka 3 miliamperów HD-tDCS przez 30 minut, przez 5-30 sesji.
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Uczestnicy otrzymają HD-tDCS przy 3 mA przez 30 minut, przez 5-30 sesji.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Lateral Temporal Cortex Connectivity
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Self-Report of Contentment With Memory
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
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Zmiana zdolności hamowania
Ramy czasowe: Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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A priori zamiar pomiaru poprzez zmianę w NIH Toolbox Flanker Inhibitory Control and Attention Test Test Score
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Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Zmiana zdolności konceptualizacji
Ramy czasowe: Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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A priori zamiar pomiaru poprzez zmianę wyniku testu sortowania kart zmiany wymiarów NIH Toolbox
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Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Zmiana pamięci sekwencji obrazów
Ramy czasowe: Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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A priori zamiar pomiaru poprzez zmianę wyniku testu pamięci sekwencji obrazów zestawu narzędzi NIH
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Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Zmiana zdolności pamięci roboczej
Ramy czasowe: Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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A priori zamiar pomiaru poprzez zmianę wyniku testu pamięci roboczej sortowania listy narzędzi NIH
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Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Zmiana szybkości przetwarzania
Ramy czasowe: Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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A priori zamiar pomiaru poprzez zmianę wyniku testu szybkości przetwarzania porównania wzorców NIH Toolbox
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Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Zmiana w funkcjonowaniu wzrokowo-przestrzennym
Ramy czasowe: Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Mierzone na podstawie zmiany wyniku wskaźnika wzrokowo-przestrzennego RBANS
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Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Zmiana w funkcjonowaniu języka
Ramy czasowe: Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Mierzona poprzez zmianę wyniku RBANS Language Index
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Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Zmiana w Uwaga
Ramy czasowe: Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Mierzona poprzez zmianę wyniku RBANS Attention Index
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Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Zmiana w funkcjonowaniu pamięci
Ramy czasowe: Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Mierzona poprzez zmianę wyniku Indeksu pamięci bezpośredniej RBANS
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Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Zmiana w funkcjonowaniu poznawczym
Ramy czasowe: Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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A priori zamiar pomiaru poprzez zmiany w wynikach podtestów RBANS
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Stan wyjściowy i po interwencji (po sesjach tDCS 5 i 30)
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Benjamin Hampstead, PhD, Associate Professor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HUM00146180
- 1R01AG058724 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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