Effects of Individualized Theta-tACS on a Working Memory Training at SCD
NCT Number: NCT06501755
Acronym: tACOSenior
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Subjective Cognitive Decline
Interventions: DEVICE: transcranial alternating current stimulation (tACS)
Sponsor: University Hospital Tuebingen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-19
Completion Date: 2025-07-31
Locations: Universitätsklinik für Psychiatrie und Psychotherapie Tübingen, Neurophysiologie & Interventionelle Neuropsychiatrie, Tübingen, DE, Tübingen, Baden Württemberg, 72076, Germany

Summary:
The aim of the study is to investigate the effects and mechanisms of action of an individualized transcranial alternating current stimulation in the theta-range (ITF-tACS) on a three day spatial working memory training in healthy older adults with subjective cognitive decline (SCD).

Primary Outcome Measures: Reaction time in the spatial 2-, 3-, 4-back at the post-session, Reaction times \< 150ms and \> M + 3 SD after visual inspection via histogram and box plot per participant will be excluded from the analysis, Post-session (10-12 days after the baseline-session)|d prime in the spatial 2-, 3-, 4-back at the post-session, d prime = z(Hits) - z(False Alarms), Post-session (10-12 days after the baseline-session)
Secondary Outcome Measures: Reaction time in the adaptive spatial n-back during the trainingssessions, Reaction times \< 150ms and \> M + 3 SD after visual inspection via histogram and box plot per participant will be excluded from the analysisfrom the analysis, Trainingssessions (conducted in the week after the baseline-session with each 2 days apart)|Reaction time in the spatial 2-, 3-, 4-back at the follow-up session, Reaction times \< 150ms and \> M + 3 SD after visual inspection via histogram and box plot per participant will be excluded from the analysis, Follow-up session (1 month after the post-session)|d prime in the spatial 2-, 3-, 4-back at the follow-up session, d prime = z(Hits) - z(False Alarms), Follow-up session (1 month after the post-session)|Score on a 10-point likert scale about the worries on cognitive abilities at the post-session, The task of the participant is to rate the extend of worries about their cognitive abilities on a ten-stage scale from "no worries" to "very strong worries". With higher scores indicating stronger worries., Post-session (10-12 days after the baseline-session)|Sumscores in the digit span task at the post-session, Post-session (10-12 days after the baseline-session)|Theta-power in the EEG at the post-session, Post-session (10-12 days after the baseline-session)|Connectivity of the front-parietal network in the EEG at the post-session, Post-session (10-12 days after the baseline-session)
Other Outcome Measures: Sumscores in the digit span task at the follow-up session, Follow-up session (1 month after the post-session)|Score on a 10-point likert scale about the worries on cognitive abilities at the follow-up session, The task of the participant is to rate the extend of worries about their cognitive abilities on a ten-stage scale from "no worries" to "very strong worries". With higher scores indicating stronger worries., Follow-up session|Score in the WHO-5 (Topp et al., 2015) in the post-session, The task of the participants is to rate 5 items on a six-stage scale from "all of the time" to "at non time". With higher scores indicating a higher quality of life., Post-session (10-12 days after the baseline-session)|Score in the WHO-5 (Topp et al., 2015) in the follow-up session, The task of the participants is to rate 5 items on a six-stage scale from "all of the time" to "at non time". With higher scores indicating a higher quality of life., Follow-up session (1 month after the post-session)|Score in the Insomnia Severity Index (Morin, 1993) in the post-session, The task of the participants is to rate 7 items on a five-stage scale from "not at all" to "very strong" for items 1 to 3, on a scale from "very satisfied" to "very dissatisfied" for item 4 and on a scale from "not at all" to "very strong" for items 5 to 7. With higher scores indicating a stronger impairment in the sleep., post-session (10-12 days after the baseline-session)|Score in the Insomnia Severity Index (Morin, 1993) in the follow-up session, The task of the participants is to rate 7 items on a five-stage scale from "not at all" to "very strong" for items 1 to 3, on a scale from "very satisfied" to "very dissatisfied" for item 4 and on a scale from "not at all" to "very strong" for items 5 to 7. With higher scores indicating a stronger impairment in the sleep., Follow-up session (1 month after the post-session)|Score in the Subjective Cognitive Decline Questionnaire (Rami et al., 2014) in the post-session, The task of the participants is to either to agree ("yes") or disagree ("no") to 24 items regarding their self-perceived cognitive decline over the last two years (MyCog). With higher scores indicating a stronger self-perceived cognitive decline., Post-session (10-12 days after the baseline-session)|Score in the Subjective Cognitive Decline Questionnaire (Rami et al., 2014) in the follow-up session, The task of the participants is to either to agree ("yes") or disagree ("no") to 24 items regarding their self-perceived cognitive decline over the last two years (MyCog). With higher scores indicating a stronger self-perceived cognitive decline., Follow-up session (1 month after the post-session)|Score in the Karolinska Sleepiness Scale (Akerstadt & Gillberg, 1990) after the trainingssessions, The task of the participants is to rate 5 items on a ninge-stage scale from "extremely awake" to "Very sleepy, can only stay awake with great difficulty; fight against sleep". With higher scores indicating a higher degree of sleepiness., Trainingssessions (conducted in the week after the baseline-session with each 2 days apart)