Memory DeficitsNCT05569902
tACS Improves Memory in Elders With Subjective Memory Complaints
A study testing active tACS in people with Memory Deficits and tACS, run by University of Tehran at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Memory Deficits, tACS
- What is being tested?
- active tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteIran
- Study dates
- 1 Oct 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remember NIBS? tACS Improves Memory Performance in Elders With Subjective Memory Complaints
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.
- Conditions
- Memory Deficits, tACS
- Being tested
- active tACS, sham tACS
- Keywords
- Episodic memory, medial Prefrontal Cortex, tACS, SMC
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Active tACS | Experimental | Participants in this group received 20 minutes of active 6 Hz stimulation over the medial prefrontal cortex. Receives: Device: active tACS |
| Sham tACS | Sham comparator | Participants in this group received 20 minutes of sham stimulation over the medial prefrontal cortex. Receives: Device: sham tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance
Rey auditory-verbal learning test (RAVLT)
Measured: 25 minutes i.e., before versus after the stimulation
Secondary outcomes (2)
Change in EEG power in theta frequency band
Spectral analysis measuring power in different frequency bands
Measured: 30 minutes, i.e., before versus after stimulation
Change in phase synchronization connectivity in theta frequency band
Phase relations between neural signals realized by means of phase-locking values (PLV)
Measured: 30 minutes, i.e., before versus after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Oct 2021
- Primary completion1 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory DeficitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tehran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, reza kazemi, University of Tehran
- Investigators
- Reza Rostami, M.D., Study director, University of TehranSahereh Varastegan, MSc, Principal investigator, University of Tehran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569902
- Sponsor's protocol ID
- tACS
- Status last verified
- Oct 2022
- First submitted
- 24 Sep 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remember NIBS? tACS Improves Memory Performance in Elders With Subjective Memory Complaints
- ClinicalTrials.gov ID
- NCT05569902
- Acronym / sponsor ID
- tACS
- Conditions
- Memory Deficits, tACS
- Keywords
- Episodic memory, medial Prefrontal Cortex, tACS, SMC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of TehranUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tACS | Experimental | Device: active tACSParticipants in this group received 20 minutes of active 6 Hz stimulation over the medial prefrontal cortex. |
| Sham tACS | Sham comparator | Device: sham tACSParticipants in this group received 20 minutes of sham stimulation over the medial prefrontal cortex. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active tACStranscranial 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. | Device | Active tACS |
| sham tACStranscranial 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. | Device | Sham tACS |
Primary outcome
Change in performance
Time frame: 25 minutes i.e., before versus after the stimulation
Rey auditory-verbal learning test (RAVLT)
2 secondary outcomes
Change in EEG power in theta frequency band
Time frame: 30 minutes, i.e., before versus after stimulation
Change in phase synchronization connectivity in theta frequency band
Time frame: 30 minutes, i.e., before versus after stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Rostami, M.D. study director
University of Tehran
Sahereh Varastegan, MSc principal investigator
University of Tehran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tACS in people with Memory Deficits and tACS, run by University of Tehran at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in performance (time frame: 25 minutes i.e., before versus after the stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.