Effects of Individualized Theta-tACS on a Working Memory Training at SCD
NCT ID: NCT06501755
Last Updated: 2024-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2024-07-19
2025-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
tDCS-enhanced Working Memory Training in Subjective Cognitive Decline
NCT03236454
Cognitive Ability Training in Seniors
NCT02587338
The Effect of tES on a Cognitive Training
NCT03475446
Patient Centered-Rehabilitation ver111090.1
NCT03034954
Association of Transcranial Alternating Current Stimulation with Digital Cognitive Training for Cognitive Remediation in Older Adults
NCT06733714
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 H2.1 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 H2.2 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 H2.3 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 H2.4 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 H2.5 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 \< 0.05. 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 \> 1/3 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 09/2024.
The study will provide important implications for the usage of multi-session ITF-tACS in the context of healthy aging.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sham tACS
Intensity: 2 mA (peak-to-peak), localisation: F4/P4, phase-shift between the electrodes: 0°,duration: 20s at the begin and the end of the task (adaptive spatial n-back) with additionally each time 15 s fade-in and fade-out, frequency: 6Hz.
transcranial alternating current stimulation (tACS)
Transcrainal alternating current stimulation (tACS) is a non-invasive brain-stimulation where weak sinusoidal electric current with frequencies within the EEG-range is applied over electrodes on the scalp. In the study we use the DC-Stimulator MC, neuroConn, Ilmenau for the stimulation.The device is authorized as medical device for the application on humans in Germany with a CE-Identification. We use two circular (area each = ca. 7.07 cm\^2) and two ring-shaped (area each = 40 cm\^2) rubber electrodes. Impedances are kept \< 15 kOhm.
Individualized Theta-Frequency tACS
Intensity: 2 mA (peak-to-peak), localisation: F4/P4, phase-shift between the electrodes: 0°, duration: 27 min with 15 s fade-in and fade-out, frequency: peak theta-frequency at the baseline measurement during the execution of the spatial 2-, 3-, and 4-back.
transcranial alternating current stimulation (tACS)
Transcrainal alternating current stimulation (tACS) is a non-invasive brain-stimulation where weak sinusoidal electric current with frequencies within the EEG-range is applied over electrodes on the scalp. In the study we use the DC-Stimulator MC, neuroConn, Ilmenau for the stimulation.The device is authorized as medical device for the application on humans in Germany with a CE-Identification. We use two circular (area each = ca. 7.07 cm\^2) and two ring-shaped (area each = 40 cm\^2) rubber electrodes. Impedances are kept \< 15 kOhm.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
transcranial alternating current stimulation (tACS)
Transcrainal alternating current stimulation (tACS) is a non-invasive brain-stimulation where weak sinusoidal electric current with frequencies within the EEG-range is applied over electrodes on the scalp. In the study we use the DC-Stimulator MC, neuroConn, Ilmenau for the stimulation.The device is authorized as medical device for the application on humans in Germany with a CE-Identification. We use two circular (area each = ca. 7.07 cm\^2) and two ring-shaped (area each = 40 cm\^2) rubber electrodes. Impedances are kept \< 15 kOhm.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* subjective cognitive decline with a duration \> 6 month and without a concrete cause
* right-handedness (score \> 48 in the Edinburgh Handedness Inventory (EHI; Oldfield, 1971))
* corrected or sufficient eyesight
* sufficient knowledge in German
* ability to consent
Exclusion Criteria
* score \> 13 in the DemTect (Kalbe et al., 2019)
* score \> 4 in the Geriatric Depression Scale Short Form (GDS-SF; Sheikh \& Yesavage, 1986)
* score \> 16 Geriatric Anxiety Scale German version(GAS-G; Gottschling et al., 2016)
* substance abuse or dependence
* epileptic seizure in medical history
* metall in skalp-area
* pacemaker
* gravidity
* psychiatric medication
* benzodiazepines in a dosage \> 1 mg Lorazepam
* participation in a tACS in history
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital Tuebingen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Prof. Dr. Christian Plewnia
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinik für Psychiatrie und Psychotherapie Tübingen, Tübingen, DE
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universitätsklinik für Psychiatrie und Psychotherapie Tübingen, Neurophysiologie & Interventionelle Neuropsychiatrie, Tübingen, DE
Tübingen, Baden-Wurttemberg, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.
Gottschling, J, Segal, D. L., Häusele C., Spinath, F. M., & Stoll, G. Assessment of Anxiety in Older Adults: Translation and Psychometric Evaluation of the German Version of the Geriatric Anxiety Scale (GAS). Journal of Psychopathology and Behavior Assessment. 2016; 38: 136-148. doi: 10.1007/s10862-015-9504-z
Kalbe, E., Calabrese, P., & Kessler, J. (2019). DemTect® Zur Unterstützung der Demenz-Diagnostik (1. Auflage.). Hogrefe.
Morin, C.M. (1993). Insomnia: Psychological assessment and management. Guilford Press.
Rami L, Mollica MA, Garcia-Sanchez C, Saldana J, Sanchez B, Sala I, Valls-Pedret C, Castellvi M, Olives J, Molinuevo JL. The Subjective Cognitive Decline Questionnaire (SCD-Q): a validation study. J Alzheimers Dis. 2014;41(2):453-66. doi: 10.3233/JAD-132027.
Sheikh, R.L. & Yesavage, J.A. Geriatric Depression Scale (GDS). Clinical Gerontologist. 1986; 5: 165-173.
Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
Booth SJ, Taylor JR, Brown LJE, Pobric G. The effects of transcranial alternating current stimulation on memory performance in healthy adults: A systematic review. Cortex. 2022 Feb;147:112-139. doi: 10.1016/j.cortex.2021.12.001. Epub 2021 Dec 24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
tACOSenior
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.