Mild Cognitive ImpairmentNCT04647032
Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation
A study testing Transcranial alternating current stimulation in people with Mild Cognitive Impairment, run by University of California, San Francisco at 1 site in United States.
Trial summary
The overall goal of this project is to improve cognitive control abilities in adults with mild cognitive impairment (MCI) through a form of non-invasive brain stimulation, transcranial alternating current stimulation (tACS). Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Transcranial alternating current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- Grade 12 or more education
- Normal or corrected to normal vision and hearing
- Ability to complete cognitive tasks
- Ability to cooperate and comply with all study procedures
- Ability to tolerate tACS
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- Montreal Cognitive Assessment score: 17-28
- -1 z-score on immediate memory, delayed memory, fluency, processing speed, or task switch
- Self-reported memory complaint
Who cannot join
- Neurological or psychiatric disorders other than mild cognitive impairment
- Receiving investigational medications or have participated in a trial with investigational medications within last 30 days
- Family history of epilepsy
- Implanted electronic devices (e.g., pacemaker)
- Prior head trauma
- Pregnant
Show all 15Show fewer
- IQ < 80
- Taking cholinesterase inhibitory, memantine, or psychotropic medication
- Taking anti-depressants or anti-anxiety medication
- Color blind
- Substance abuse
- Glaucoma
- Macular degeneration
- Amblyopia (lazy eye)
- Strabismus (crossed eyes)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
The overall goal of this project is to improve cognitive control abilities in adults with mild cognitive impairment (MCI) through a form of non-invasive brain stimulation, transcranial alternating current stimulation (tACS).
Read the detailed description
30 older adults aged 60-80 years with md-aMCI were randomized to 8 sessions of transcranial alternating current stimulation (tACS) with simultaneous cognitive control training (CCT). The intervention took place within the participant's home without direct researcher assistance. Half of the participants received prefrontal theta tACS during CCT and the other half received control tACS. Outcomes were assessed pre and post intervention.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Transcranial alternating current stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial alternating current stimulationDevice
Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4
| Study group | Role | What they receive |
|---|---|---|
| Theta Stimulation Group | Experimental | This group will receive 6 Hz (theta) stimulation Receives: Device: Transcranial alternating current stimulation |
| Delta Stimulation Group | Active comparator | This group will receive 1 Hz (delta) stimulation Receives: Device: Transcranial alternating current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Divided Attention Performance
Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.
Measured: Post-tACS (1-day follow-up), approximately 1 week after baseline
Divided Attention Performance
Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.
Measured: Post-tACS (1-month follow-up), approximately 1 month after baseline
Sustained Attention Performance
Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.
Measured: Post-tACS (1-day follow-up), approximately 1 week after baseline
Sustained Attention Performance
Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.
Measured: Post-tACS (1-month follow-up), approximately 1 month after baseline
Working Memory Performance
Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares.
Measured: Post-tACS (1-day follow-up), approximately 1 week after baseline
Working Memory Performance
Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares
Measured: Post-tACS (1-month follow-up), approximately 1 month after baseline
Secondary outcomes (2)
Instrumental Activities of Daily Living (IADL)
Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4).
Measured: Post-tACS (1-day follow-up), approximately 1 week after baseline
Instrumental Activities of Daily Living (IADL)
Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4).
Measured: Post-tACS (1-month follow-up), approximately 1 month after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start11 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Theodore Zanto, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647032
- Sponsor's protocol ID
- 132026a
- Other IDs
- R21AG062395
- Status last verified
- Apr 2023
- First submitted
- 10 Nov 2020
- Last updated
- 11 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The dataset includes self-reported information, behavioral and electrophysiological data. The final dataset will be stripped of identifiers prior to release for sharing, thereby anonymizing the data. We will make the anonymized data available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to attempt to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. This will be in accordance with human subject regulations.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation
- ClinicalTrials.gov ID
- NCT04647032
- Acronym / sponsor ID
- 132026a
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Posted 11 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this project is to improve cognitive control abilities in adults with mild cognitive impairment (MCI) through a form of non-invasive brain stimulation, transcranial alternating current stimulation (tACS).
Detailed description
30 older adults aged 60-80 years with md-aMCI were randomized to 8 sessions of transcranial alternating current stimulation (tACS) with simultaneous cognitive control training (CCT). The intervention took place within the participant's home without direct researcher assistance. Half of the participants received prefrontal theta tACS during CCT and the other half received control tACS. Outcomes were assessed pre and post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theta Stimulation Group | Experimental | Device: Transcranial alternating current stimulationThis group will receive 6 Hz (theta) stimulation |
| Delta Stimulation Group | Active comparator | Device: Transcranial alternating current stimulationThis group will receive 1 Hz (delta) stimulation |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- English speaking
- Grade 12 or more education
- Normal or corrected to normal vision and hearing
- Ability to complete cognitive tasks
- Ability to cooperate and comply with all study procedures
Key exclusion criteria (15 listed)
- Neurological or psychiatric disorders other than mild cognitive impairment
- Receiving investigational medications or have participated in a trial with investigational medications within last 30 days
- Family history of epilepsy
- Implanted electronic devices (e.g., pacemaker)
- Prior head trauma
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 |
|---|---|---|
| Transcranial alternating current stimulationTranscranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4 | Device | Delta Stimulation Group, Theta Stimulation Group |
Primary outcome
Divided Attention Performance
Time frame: Post-tACS (1-day follow-up), approximately 1 week after baseline
Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.
Divided Attention Performance
Time frame: Post-tACS (1-month follow-up), approximately 1 month after baseline
Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.
Sustained Attention Performance
Time frame: Post-tACS (1-day follow-up), approximately 1 week after baseline
Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.
Sustained Attention Performance
Time frame: Post-tACS (1-month follow-up), approximately 1 month after baseline
Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.
Working Memory Performance
Time frame: Post-tACS (1-day follow-up), approximately 1 week after baseline
Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares.
Working Memory Performance
Time frame: Post-tACS (1-month follow-up), approximately 1 month after baseline
Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares
2 secondary outcomes
Instrumental Activities of Daily Living (IADL)
Time frame: Post-tACS (1-day follow-up), approximately 1 week after baseline
Instrumental Activities of Daily Living (IADL)
Time frame: Post-tACS (1-month follow-up), approximately 1 month after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The dataset includes self-reported information, behavioral and electrophysiological data. The final dataset will be stripped of identifiers prior to release for sharing, thereby anonymizing the data. We will make the anonymized data available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to attempt to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. This will be in accordance with human subject regulations.
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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.
Theodore Zanto, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial alternating current stimulation in people with Mild Cognitive Impairment, run by University of California, San Francisco at 1 site in United States.
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 9 inclusion and 15 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 11 May 2023. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 11 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Divided Attention Performance (time frame: Post-tACS (1-day follow-up), approximately 1 week after baseline). The study lists 6 primary outcomes in all. 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 11 May 2023.