Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501755
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-27
Brief Title:
Effects of Individualized Theta-tACS on a Working Memory Training at SCD
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Effects and Mechanisms of Action of an Individualized Theta Frequency Transcranial Alternating Current Stimulation ITF-tACS on a Working Memory Training at Healthy Older Adults With Subjective Cognitive Decline SCD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
tACOSenior
Brief 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
Detailed Description:
This study uses a randomized double-blind two-armed sham-controlled between-subjects design It is conducted at the University Hospital for Psychiatry and Psychotherapy Tübingen Germany Participants older than 60 years and with subjective cognitive decline SCD will be included Other inclusion and exclusion criteria are displayed under Eligibility Participants are recruited via email-newsletters at the University of Tübingen flyers and newspaper advertisement Participants will receive financial compensation A stratified block randomization is applied after the inclusion of the participants and before the baseline-session The person generating the randomization list is not involved with data collection Operators do not have access to the randomization list during the data collection
Sample size is N 36 with n 18 participants in each group As a phase 2 study the aim of this study is the determination of effect sizes which can be used for further investigations Thus due to a lack of comparable studies no power analysis could be conducted The group size is therefore based on the most frequently found group size n 18 observed in a systematic review regarding the effects of tACS targeting the memory in healthy adults
The study includes seven time points screening-session baseline-session in the end of the first week of data-collection three training sessions within the second week of data-collection each session two days apart post-session 10-12 days after the baseline-session in the beginning of the third week of data-collection and follow-up session one month after the post-session Online tACS is applied during the training sessions while the participants will conduct an adaptive spatial n-back task online stimulation Resting-state EEG as well as EEGs during the spatial 2- 3- 4-back at the baseline- and the post-session are conducted Two groups are compared one group with individualized theta-tACS ITF-tACS and one with sham-tACS
Hypothesis H1 contains the effect on the trained task spatial 2- 3- 4-back at the post-session The investigators expect a higher performance in the group with ITF-tACS compared to sham-tACS To test this hypothesis two ANCOVAs dependent variable performance at post-session Reaction time and d prime Covariate performance at baseline-session will be conducted
Hypothesis H21 contains the effect on the trained task in the training sessions concurrent to the tACS The investigators expect a higher performance in the group with ITF-tACS compared to sham-tACS in all sessions To test the hypothesis a linear mixed model will be conducted
Hypothesis H22 contains the long-term effect on the trained task at the follow-up session The investigators expect a higher performance in the group with ITF-tACS compared to sham-tACS To test the hypothesis two ANCOVAs will be conducted
Hypothesis H23 contains the transfer effects on the verbal working memory digit span task at the post-session The investigators expect a higher performance in the group with ITF-tACS compared to sham-tACS To test the hypothesis three ANCOVAs will be conducted
Hypothesis H24 contains the effect of the training on the subjective cognitive decline 10-point Likert-scale at the post-session The investigators expect a lower scoring in the group with ITF-tACS compared to sham-tACS To test the hypothesis an ANCOVA will be conducted
Hypothesis H25 contains the effect of neurophysiological measures of the spatial working memory EEG The investigators expect a higher theta-power and fronto-parietal connectivity in the group with ITF-tACS compared to sham-tACS
Exploratively measures for the accuracy in the trained task transfer effect at follow-up session for the transfer task subjective cognitive decline subjective cognitive decline questionnaire quality of live WHO-5 side effects and for sleep Karolinska sleepiness scale Insomnia Severity Index are evaluated
For all analyses the alpha level for significance is set to p 005 Because reaction times 150 ms are regarded as unintended and mean reaction time 3 SD per participant are regarded as additionally including different processes than only working memory reaction times 150 ms and mean reaction time 3 SD per participant per session are excluded from the analyses Participants who did not complete the post-session or will miss 13 of the training sessions are excluded from analyses We test model assumptions in all analyses and control for multiple testing in the primary analyses An interim analysis is conducted in 092024
The study will provide important implications for the usage of multi-session ITF-tACS in the context of healthy aging
Sample size is N 36 with n 18 participants in each group As a phase 2 study the aim of this study is the determination of effect sizes which can be used for further investigations Thus due to a lack of comparable studies no power analysis could be conducted The group size is therefore based on the most frequently found group size n 18 observed in a systematic review regarding the effects of tACS targeting the memory in healthy adults
The study includes seven time points screening-session baseline-session in the end of the first week of data-collection three training sessions within the second week of data-collection each session two days apart post-session 10-12 days after the baseline-session in the beginning of the third week of data-collection and follow-up session one month after the post-session Online tACS is applied during the training sessions while the participants will conduct an adaptive spatial n-back task online stimulation Resting-state EEG as well as EEGs during the spatial 2- 3- 4-back at the baseline- and the post-session are conducted Two groups are compared one group with individualized theta-tACS ITF-tACS and one with sham-tACS
Hypothesis H1 contains the effect on the trained task spatial 2- 3- 4-back at the post-session The investigators expect a higher performance in the group with ITF-tACS compared to sham-tACS To test this hypothesis two ANCOVAs dependent variable performance at post-session Reaction time and d prime Covariate performance at baseline-session will be conducted
Hypothesis H21 contains the effect on the trained task in the training sessions concurrent to the tACS The investigators expect a higher performance in the group with ITF-tACS compared to sham-tACS in all sessions To test the hypothesis a linear mixed model will be conducted
Hypothesis H22 contains the long-term effect on the trained task at the follow-up session The investigators expect a higher performance in the group with ITF-tACS compared to sham-tACS To test the hypothesis two ANCOVAs will be conducted
Hypothesis H23 contains the transfer effects on the verbal working memory digit span task at the post-session The investigators expect a higher performance in the group with ITF-tACS compared to sham-tACS To test the hypothesis three ANCOVAs will be conducted
Hypothesis H24 contains the effect of the training on the subjective cognitive decline 10-point Likert-scale at the post-session The investigators expect a lower scoring in the group with ITF-tACS compared to sham-tACS To test the hypothesis an ANCOVA will be conducted
Hypothesis H25 contains the effect of neurophysiological measures of the spatial working memory EEG The investigators expect a higher theta-power and fronto-parietal connectivity in the group with ITF-tACS compared to sham-tACS
Exploratively measures for the accuracy in the trained task transfer effect at follow-up session for the transfer task subjective cognitive decline subjective cognitive decline questionnaire quality of live WHO-5 side effects and for sleep Karolinska sleepiness scale Insomnia Severity Index are evaluated
For all analyses the alpha level for significance is set to p 005 Because reaction times 150 ms are regarded as unintended and mean reaction time 3 SD per participant are regarded as additionally including different processes than only working memory reaction times 150 ms and mean reaction time 3 SD per participant per session are excluded from the analyses Participants who did not complete the post-session or will miss 13 of the training sessions are excluded from analyses We test model assumptions in all analyses and control for multiple testing in the primary analyses An interim analysis is conducted in 092024
The study will provide important implications for the usage of multi-session ITF-tACS in the context of healthy aging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None