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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05569902
Other study ID # tACS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date August 1, 2022

Study information

Verified date October 2022
Source University of Tehran
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Subjective memory complaints (SMC), the main cognitive component of which is event memory, is a predictor of Alzheimer's disease in elderly people. The purpose of this study was to investigate the effect of transcranial alternating current stimulation (tACS) with theta frequency (6 Hz) on the medial prefrontal cortex in the improvement of episodic memory in individuals with SMC in a double blind, randomized, and sham-controlled parallel study. Sixteen participants with SMC received either active or sham theta tACS on the medial prefrontal cortex (mPFC). EEG was recorded and Rey Auditory Verbal Learning Test (RAVLT) was administered. The aim of the current study was to see if theta tACS over the mPFC can improve event memory in individuals with SMC and thus can be considered a potential therapeutic intervention for this population or not.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date August 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Being 50 or older, - Mini Mental State Examination (MMSE) grade from 27 to 30 - Total score of 58 or more on the Everyday Memory Questionnaire (EMQ) - no indications of depression and anxiety measured by Geriatric Depression Scale (GDS) and State-Trait Anxiety Inventory (STAI) - No sign of dementia based on Diagnostic and statistical manual of mental disorder, 5th edition (DSM-V) criteria Exclusion Criteria: - History of a major psychological or neurological condition - History of head trauma leading to unconsciousness, - Presence of metal in the head - History of seizures - Serious cardiovascular disease - Use of medications with an impact on cognitive functions - Recent use of alcohol or substance abuse

Study Design


Related Conditions & MeSH terms


Intervention

Device:
active tACS
transcranial alternating current stimulation is a non-invasive method of entraining specific frequency bands in the brain by applying weak intensities of electric current in a desired shape and phase to the desired brain regions.
sham tACS
transcranial alternating current stimulation is a non-invasive method of entraining specific frequency bands in the brain by applying weak intensities of electric current in a desired shape and phase to the desired brain regions.

Locations

Country Name City State
Iran, Islamic Republic of National Brain Mapping Lab Tehran

Sponsors (1)

Lead Sponsor Collaborator
University of Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in performance Rey auditory-verbal learning test (RAVLT) 25 minutes i.e., before versus after the stimulation
Secondary Change in EEG power in theta frequency band Spectral analysis measuring power in different frequency bands 30 minutes, i.e., before versus after stimulation
Secondary Change in phase synchronization connectivity in theta frequency band Phase relations between neural signals realized by means of phase-locking values (PLV) 30 minutes, i.e., before versus after stimulation
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