tACS Improves Memory in Elders With Subjective Memory Complaints

Sponsor

University of Tehran (Other)

Overall Status

Completed

CT.gov ID

NCT05569902

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Memory Deficits tACS	Device: active tACS Device: sham tACS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Remember NIBS? tACS Improves Memory Performance in Elders With Subjective Memory Complaints

Actual Study Start Date :

Oct 1, 2021

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active tACS Participants in this group received 20 minutes of active 6 Hz stimulation over the medial prefrontal cortex.	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 Comparator: Sham tACS Participants in this group received 20 minutes of sham stimulation over the medial prefrontal cortex.	Device: 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.

Arm

Intervention/Treatment

Experimental: Active tACS

Participants in this group received 20 minutes of active 6 Hz stimulation over the medial prefrontal cortex.

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 Comparator: Sham tACS

Participants in this group received 20 minutes of sham stimulation over the medial prefrontal cortex.

Device: sham tACS

Outcome Measures

Primary Outcome Measures

Change in performance [25 minutes i.e., before versus after the stimulation]
Rey auditory-verbal learning test (RAVLT)

Secondary Outcome Measures

Change in EEG power in theta frequency band [30 minutes, i.e., before versus after stimulation]
Spectral analysis measuring power in different frequency bands
Change in phase synchronization connectivity in theta frequency band [30 minutes, i.e., before versus after stimulation]
Phase relations between neural signals realized by means of phase-locking values (PLV)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Brain Mapping Lab	Tehran		Iran, Islamic Republic of	1439957131

Sponsors and Collaborators

University of Tehran

Investigators

Study Director: Reza Rostami, M.D., University of Tehran
Principal Investigator: Sahereh Varastegan, MSc, University of Tehran

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

reza kazemi, Assistant professor, University of Tehran

ClinicalTrials.gov Identifier:

NCT05569902

Other Study ID Numbers:

tACS

First Posted:

Oct 6, 2022

Last Update Posted:

Oct 10, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by reza kazemi, Assistant professor, University of Tehran

Episodic memory

medial Prefrontal Cortex

tACS

SMC

Additional relevant MeSH terms:

Memory Disorders

Study Results

No Results Posted as of Oct 10, 2022