tACS Improves Memory in Elders With Subjective Memory Complaints
Primary Purpose
Memory Deficits, tACS
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
active tACS
sham tACS
Sponsored by
About this trial
This is an interventional treatment trial for Memory Deficits focused on measuring Episodic memory, medial Prefrontal Cortex, tACS, SMC
Eligibility Criteria
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
Sites / Locations
- National Brain Mapping Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active tACS
Sham tACS
Arm Description
Participants in this group received 20 minutes of active 6 Hz stimulation over the medial prefrontal cortex.
Participants in this group received 20 minutes of sham stimulation over the medial prefrontal cortex.
Outcomes
Primary Outcome Measures
Change in performance
Rey auditory-verbal learning test (RAVLT)
Secondary Outcome Measures
Change in EEG power in theta frequency band
Spectral analysis measuring power in different frequency bands
Change in phase synchronization connectivity in theta frequency band
Phase relations between neural signals realized by means of phase-locking values (PLV)
Full Information
NCT ID
NCT05569902
First Posted
September 24, 2022
Last Updated
October 5, 2022
Sponsor
University of Tehran
1. Study Identification
Unique Protocol Identification Number
NCT05569902
Brief Title
tACS Improves Memory in Elders With Subjective Memory Complaints
Official Title
Remember NIBS? tACS Improves Memory Performance in Elders With Subjective Memory Complaints
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tehran
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Deficits, tACS
Keywords
Episodic memory, medial Prefrontal Cortex, tACS, SMC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active tACS
Arm Type
Experimental
Arm Description
Participants in this group received 20 minutes of active 6 Hz stimulation over the medial prefrontal cortex.
Arm Title
Sham tACS
Arm Type
Sham Comparator
Arm Description
Participants in this group received 20 minutes of sham stimulation over the medial prefrontal cortex.
Intervention Type
Device
Intervention Name(s)
active tACS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham tACS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in performance
Description
Rey auditory-verbal learning test (RAVLT)
Time Frame
25 minutes i.e., before versus after the stimulation
Secondary Outcome Measure Information:
Title
Change in EEG power in theta frequency band
Description
Spectral analysis measuring power in different frequency bands
Time Frame
30 minutes, i.e., before versus after stimulation
Title
Change in phase synchronization connectivity in theta frequency band
Description
Phase relations between neural signals realized by means of phase-locking values (PLV)
Time Frame
30 minutes, i.e., before versus after stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Rostami, M.D.
Organizational Affiliation
University of Tehran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sahereh Varastegan, MSc
Organizational Affiliation
University of Tehran
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Brain Mapping Lab
City
Tehran
ZIP/Postal Code
1439957131
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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tACS Improves Memory in Elders With Subjective Memory Complaints
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