Subjective Cognitive DeclinetACOSeniorNCT06501755
Effects of Individualized Theta-tACS on a Working Memory Training at SCD
A study testing transcranial alternating current stimulation (tACS) in people with Subjective Cognitive Decline, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subjective Cognitive Decline
- What is being tested?
- transcranial alternating current stimulation (tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jul 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >/= 60 years
- 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
Who cannot join
- neuropsychiatric diagnose
- 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
Show all 12Show fewer
- metall in skalp-area
- pacemaker
- gravidity
- psychiatric medication
- benzodiazepines in a dosage > 1 mg Lorazepam
- participation in a tACS in history
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinik für Psychiatrie und Psychotherapie Tübingen, Neurophysiologie & Interventionelle Neuropsychiatrie, Tübingen, DE
Tübingen, Baden-Wurttemberg, 72076
About this study
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)
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).
Read the 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 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
- Subjective Cognitive Decline
- Being tested
- transcranial alternating current stimulation (tACS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial alternating current stimulation (tACS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham tACS | Sham comparator | 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. Receives: Device: transcranial alternating current stimulation (tACS) |
| Individualized Theta-Frequency tACS | Experimental | 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. Receives: Device: transcranial alternating current stimulation (tACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Post-session (10-12 days after the baseline-session)
Secondary outcomes (7)
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
Measured: 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
Measured: 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)
Measured: 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.
Measured: Post-session (10-12 days after the baseline-session)
Sumscores in the digit span task at the post-session
Measured: Post-session (10-12 days after the baseline-session)
Theta-power in the EEG at the post-session
Measured: Post-session (10-12 days after the baseline-session)
Connectivity of the front-parietal network in the EEG at the post-session
Measured: Post-session (10-12 days after the baseline-session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start19 Jul 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Christian Plewnia, Principal investigator, Universitätsklinik für Psychiatrie und Psychotherapie Tübingen, Tübingen, DE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501755
- Sponsor's protocol ID
- tACOSenior
- Acronym
- tACOSenior
- Status last verified
- Apr 2024
- First submitted
- 27 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 2265922Gottschling, 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.
PubMed 24625794Sheikh, 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.
PubMed 25831962Booth 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.
PubMed 35032750
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06501755
- Acronym / sponsor ID
- tACOSenior / tACOSenior
- Conditions
- Subjective Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 19 Jul 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tACS | Sham comparator | Device: transcranial alternating current stimulation (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. |
| Individualized Theta-Frequency tACS | Experimental | Device: transcranial alternating current stimulation (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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age >/= 60 years
- 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
Key exclusion criteria (12 listed)
- neuropsychiatric diagnose
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Individualized Theta-Frequency tACS, Sham tACS |
Primary outcome
Reaction time in the spatial 2-, 3-, 4-back at the post-session
Time frame: Post-session (10-12 days after the baseline-session)
Reaction times < 150ms and > M + 3 SD after visual inspection via histogram and box plot per participant will be excluded from the analysis
d prime in the spatial 2-, 3-, 4-back at the post-session
Time frame: Post-session (10-12 days after the baseline-session)
d prime = z(Hits) - z(False Alarms)
7 secondary outcomes
Reaction time in the adaptive spatial n-back during the trainingssessions
Time frame: 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
Time frame: Follow-up session (1 month after the post-session)
d prime in the spatial 2-, 3-, 4-back at the follow-up session
Time frame: 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
Time frame: Post-session (10-12 days after the baseline-session)
Sumscores in the digit span task at the post-session
Time frame: Post-session (10-12 days after the baseline-session)
Theta-power in the EEG at the post-session
Time frame: Post-session (10-12 days after the baseline-session)
Connectivity of the front-parietal network in the EEG at the post-session
Time frame: Post-session (10-12 days after the baseline-session)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Background: PubMed 2265922Akerstedt 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.
- BackgroundGottschling, 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
- BackgroundKalbe, E., Calabrese, P., & Kessler, J. (2019). DemTect® Zur Unterstützung der Demenz-Diagnostik (1. Auflage.). Hogrefe.
- BackgroundMorin, C.M. (1993). Insomnia: Psychological assessment and management. Guilford Press.
- Background: PubMed 24625794Rami 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.
- BackgroundSheikh, R.L. & Yesavage, J.A. Geriatric Depression Scale (GDS). Clinical Gerontologist. 1986; 5: 165-173.
- Background: PubMed 25831962Topp 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.
- Background: PubMed 35032750Booth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. Christian Plewnia principal investigator
Universitätsklinik für Psychiatrie und Psychotherapie Tübingen, Tübingen, DE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial alternating current stimulation (tACS) in people with Subjective Cognitive Decline, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M.Sc. Selina Galefskii (004917655188703, selina.galefski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time in the spatial 2-, 3-, 4-back at the post-session (time frame: Post-session (10-12 days after the baseline-session)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06501755, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.