NCT05569902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

September 24, 2022

Last Update Submit

October 5, 2022

Conditions

Keywords

Episodic memorymedial Prefrontal CortextACSSMC

Outcome Measures

Primary Outcomes (1)

  • Change in performance

    Rey auditory-verbal learning test (RAVLT)

    25 minutes i.e., before versus after the stimulation

Secondary Outcomes (2)

  • Change in EEG power in theta frequency band

    30 minutes, i.e., before versus after stimulation

  • Change in phase synchronization connectivity in theta frequency band

    30 minutes, i.e., before versus after stimulation

Study Arms (2)

Active tACS

EXPERIMENTAL

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

Device: active tACS

Sham tACS

SHAM COMPARATOR

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

Device: sham tACS

Interventions

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.

Active tACS
sham tACSDEVICE

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

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Brain Mapping Lab

Tehran, 1439957131, Iran

Location

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Reza Rostami, M.D.

    University of Tehran

    STUDY DIRECTOR
  • Sahereh Varastegan, MSc

    University of Tehran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 24, 2022

First Posted

October 6, 2022

Study Start

October 1, 2021

Primary Completion

June 1, 2022

Study Completion

August 1, 2022

Last Updated

October 10, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations