Effects of Individualized Theta-tACS on a Working Memory Training at SCD

NCT06501755 | Not Yet Recruiting

• 1 other identifier: tACOSenior
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Subjective Cognitive Decline

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Reaction time in the adaptive spatial n-back during the trainingssessions

  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

  Follow-up session (1 month after the post-session)

• d prime in the spatial 2-, 3-, 4-back 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 post-session

  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)

Other Outcomes (9)

• 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

  Follow-up session

• Score in the WHO-5 (Topp et al., 2015) in the post-session

  Post-session (10-12 days after the baseline-session)

Study Arms (2)

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.

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.

Device: transcranial alternating current stimulation (tACS)

Interventions

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.

Individualized Theta-Frequency tACS; Sham tACS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• metall in skalp-area
• pacemaker
• gravidity
• psychiatric medication
• benzodiazepines in a dosage \> 1 mg Lorazepam
• participation in a tACS in history

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Universitätsklinik für Psychiatrie und Psychotherapie Tübingen, Neurophysiologie & Interventionelle Neuropsychiatrie, Tübingen, DE

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (8)

• 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.

  PMID: 2265922 BACKGROUND

• 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

  BACKGROUND

• Kalbe, E., Calabrese, P., & Kessler, J. (2019). DemTect® Zur Unterstützung der Demenz-Diagnostik (1. Auflage.). Hogrefe.

  BACKGROUND

• Morin, C.M. (1993). Insomnia: Psychological assessment and management. Guilford Press.

  BACKGROUND

• 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.

  PMID: 24625794 BACKGROUND

• Sheikh, R.L. & Yesavage, J.A. Geriatric Depression Scale (GDS). Clinical Gerontologist. 1986; 5: 165-173.

  BACKGROUND

• 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.

  PMID: 25831962 BACKGROUND

• 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.

  PMID: 35032750 BACKGROUND

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Prof. Dr. Christian Plewnia

  Universitätsklinik für Psychiatrie und Psychotherapie Tübingen, Tübingen, DE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M.Sc. Selina Galefskii

CONTACT

004917655188703; selina.galefski@gmail.com

Dr. Tobias Schwippel

CONTACT

004917684090293; schwippel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 15, 2024
• Study Start: July 19, 2024
• Primary Completion: May 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-04

Locations

DE (1)