AgingNCT05680701
Modulating Cortical Dynamics of Dual-task Standing in MCI
A study testing real tACS in people with Aging and Mild Cognitive Impairment, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
The investigators have designed a brain stimulation study to understand its effect on an individual's standing, walking, and thinking abilities in older adults with and without mild cognitive impairments (MCI). Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Mild Cognitive Impairment
- What is being tested?
- real tACS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to Jan 2025
- 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 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy older adults:
- Our target population will be healthy older men and women who are cognitively intact. We will also ensure that participants are not so impaired that they cannot safely participate nor potentially benefit from the intervention.
- Age 65+ without any cognitive impairment (based in MoCA or TICS)
- Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained able and willing to comply with all study requirements informed consent form was signed
- Ability to stand and walk independently
- Understanding of the informed consent form (ICF) will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
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- Older MCI participants:
- Age 65+
- Who have been diagnosed with cognitive impairment (based in MoCA or TICS and Clinical Dementia Rating: CDR 0.5)
- Ability to stand and walk independently
- Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
- Cut off of MOCA score >18 will be applied
- Able and willing to comply with all study requirements informed consent form was signed
- Understanding of the ICF will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
Who cannot join
- Healthy older adults:
- Exclusion Criteria have been selected to ensure safety and optimize compliance while minimizing confounds due to overt disease or conditions that may significantly influence study outcomes.
- Potentially eligible individuals will complete the Montreal Cognitive Assessment (MoCA) - score < 26
- Major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
- Self-reported diagnosis of Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, history of stroke or other neurodegenerative disorder.
- Self-reported active cancer for which chemo-/radiation therapy is being received.
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- Blindness or other disabilities that prevent task performance
- Contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp
- Inability to stand or ambulate unassisted for at least 25 feet
- Hospitalization within the past 3 months due to acute illness or as a result of musculoskeletal injury significantly affecting gait and balance
- Older MCI participants:
- Cut off of MOCA score <18 will be applied
- Major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
- Blindness or other disabilities that prevent task performance
- Self-reported history of stroke or neurodegenerative disorders other than MCI.
- Self-reported active cancer for which chemo-/radiation therapy is being received.
- Contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuro-active drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Marcus Institute for Aging Research
Boston, Massachusetts, 02131
Nicole LaGanke, 617-971-5358, nicolelaganke@hsl.harvard.edu
About this study
Official title: Understanding and Modulating Cortical Dynamics of Dual-task Standing in Older Adults With Mild Cognitive Impairment
The investigators have designed a brain stimulation study to understand its effect on an individual's standing, walking, and thinking abilities in older adults with and without mild cognitive impairments (MCI). The transcranial alternating current stimulation (tACS) technology has been safely and effectively used in hundreds of individuals. The purpose of this study is to test whether a single session of tACS as compared to sham intervention, improves standing, walking, and thinking in older adults with and without mild cognitive impairments (MCI). Approximately 60 people will take part in this study.
Read the detailed description
Mild Cognitive Impairment (MCI) represents a common prodromal phase of dementia1. As compared to older adults who are cognitively-intact, those with MCI tend to exhibit poor "dual-task" standing balance performance; that is, the ability to maintain balance when standing and simultaneously performing an unrelated cognitive task. Moreover, those older adults who have worse dual-task standing balance are more likely to suffer falls and develop dementia. As such, strategies designed to understand and enhance the brain functionality involved in dual-task standing balance hold great promise to improve daily life function, and potentially, reduce the risk of dementia in this population.
Surface electroencephalography (EEG) allows non-invasive assessment of brain activity dynamics over short periods of time, even when standing. It has been demonstrated in younger and older adults that dual-task standing is associated with brain activity fluctuations at specific frequencies. A recent study from our laboratory demonstrated that in older adults, 1) performance of a serial subtraction cognitive task when standing reduces fronto-central alpha power (i.e., fluctuations in the 8-13 Hz band), and 2) those with lower fronto-central alpha power when dual tasking exhibit worse dual task standing balance. Intriguingly, numerous studies have separately linked diminished alpha activity with worse performance on executive function and visuomotor tasks, as well as global cognitive decline in older adults. We therefore contend that therapeutic strategies designed to increase alpha activity hold promise to improve dual-task standing performance, and many other cognitive-motor functions in older adults with and without MCI. To date, however, the effects of enhancing fronto-central alpha activity to improve dual-task balance in older adults with and without MCI have not been studied.
Transcranial alternating stimulation (tACS) is a safe, non-invasive brain stimulation technique that utilizes low-amplitude alternating currents to modulate brain activity and entrain specific cortical rhythms depending on the applied stimulation frequency. Targeting alpha band (10 Hz) in the frontal region has been shown to improve cognitive functioning in healthy older adults. However, no studies have investigated the effect of 10 Hz fronto-central stimulation on EEG alpha activity and postural sway outcomes during dual-task standing in older adults with and without MCI. We thus propose to conduct a within-subject cross-over, sham-controlled study in 30 older adults without an overt disease and 30 older adults with MCI. Participants will undergo dual-task standing and cognitive assessments immediately before and after single sessions of 10 Hz tACS (fronto-central alpha stimulation), and active-sham to understand the effect of different stimulation parameters on dual-task standing performance in older adults. We hypothesize that (1) older adults with MCI will demonstrate decreased EEG alpha power during dual-task standing compared to healthy controls, and decreased alpha power will be associated with worse balance outcomes during dual-task standing, and (2) compared to the pre-stimulation condition, participants will exhibit a greater increase in alpha power during the dual-task standing condition following tACS as compared to sham stimulation, and the increase in alpha power from pre-to-post tACS will correlate with a decrease in dual-task postural sway speed from pre-to-post tACS in older adults with and without MCI.
- Conditions
- Aging, Mild Cognitive Impairment
- Being tested
- real tACS, sham tACS
- Keywords
- aging, mild cognitive impairment, non-invasive brain 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.
real tACSOther
The participant will receive one session of 10 Hz tACS for 20-minutes
sham tACSOther
The participant will receive one session of active-sham tACS for 20-minutes
| Study group | Role | What they receive |
|---|---|---|
| real tACS | Active comparator | The investigators will administer the transcranial alternating current stimulation (tACS) intervention at 10 Hz to the participants. This intervention will utilize 6 electrodes; electrode placement and current parameters for each electrode have been optimized using a standard brain to generate an average electric field of 0.25 V/m. To ensure adherence to current safety recommendations for tACS, optimizations will be constrained to a maximum of total injected current 4.0 mA and a max. current per electrode of 2.0 mA. Stimulation will start and end with a 60 s ramp up/down to maximize comfort. This standard approach is both well-tolerated and safe in older adults. In a separate visit, we will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. Receives: Other: real tACS |
| sham tACS | Sham comparator | The investigators will administer the sham tACS intervention to the participants. They will use an active sham in which very low-level alternating currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. Receives: Other: sham tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG alpha-band power
EEG oscillations and frequency coupling at 8-13 Hz
Measured: Change from immediately before and after each 20-minute session of tACS
Postural sway speed
This metric assesses the ability to control standing posture
Measured: Change from immediately before and after each 20-minute session of tACS
Secondary outcomes (5)
Timed Up and Go Test (TUG)
A common field test of mobility
Measured: This outcome will be assessed immediately before and after each 20-minute session of tACS
Postural sway area
This metric assesses the ability to control standing posture
Measured: This outcome will be assessed immediately before and after each 20-minute session of tACS
Postural sway path
This metric assesses the ability to control standing posture
Measured: This outcome will be assessed immediately before and after each 20-minute session of tACS
EEG theta-band power
EEG oscillations and frequency coupling at 4-7 Hz
Measured: This outcome will be assessed immediately before and after each 20-minute session of tACS
EEG beta-band power
EEG oscillations and frequency coupling at 13-30 Hz
Measured: This outcome will be assessed immediately before and after each 20-minute session of tACS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start13 Mar 2023
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Kahya, Hebrew SeniorLife
- Investigators
- Melike Kahya, Principal investigator, Marcus Institute for Aging Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680701
- Sponsor's protocol ID
- Pro00067596
- Status last verified
- Jan 2023
- First submitted
- 19 Dec 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The HSL Marcus Institute for Aging Research will promote the development of new research and new investigators by making the data available to outside investigators. The database will include demographic, clinical, functional, and neurophysiologic data from all participants. All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Modulating Cortical Dynamics of Dual-task Standing in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05680701
- Acronym / sponsor ID
- Pro00067596
- Conditions
- Aging, Mild Cognitive Impairment
- Keywords
- aging, mild cognitive impairment, non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 11 Jan 2023 (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.
The investigators have designed a brain stimulation study to understand its effect on an individual's standing, walking, and thinking abilities in older adults with and without mild cognitive impairments (MCI). The transcranial alternating current stimulation (tACS) technology has been safely and effectively used in hundreds of individuals. The purpose of this study is to test whether a single session of tACS as compared to sham intervention, improves standing, walking, and thinking in older adults with and without mild cognitive impairments (MCI). Approximately 60 people will take part in this study.
Detailed description
Mild Cognitive Impairment (MCI) represents a common prodromal phase of dementia1. As compared to older adults who are cognitively-intact, those with MCI tend to exhibit poor "dual-task" standing balance performance; that is, the ability to maintain balance when standing and simultaneously performing an unrelated cognitive task. Moreover, those older adults who have worse dual-task standing balance are more likely to suffer falls and develop dementia. As such, strategies designed to understand and enhance the brain functionality involved in dual-task standing balance hold great promise to improve daily life function, and potentially, reduce the risk of dementia in this population.
Surface electroencephalography (EEG) allows non-invasive assessment of brain activity dynamics over short periods of time, even when standing. It has been demonstrated in younger and older adults that dual-task standing is associated with brain activity fluctuations at specific frequencies. A recent study from our laboratory demonstrated that in older adults, 1) performance of a serial subtraction cognitive task when standing reduces fronto-central alpha power (i.e., fluctuations in the 8-13 Hz band), and 2) those with lower fronto-central alpha power when dual tasking exhibit worse dual task standing balance. Intriguingly, numerous studies have separately linked diminished alpha activity with worse performance on executive function and visuomotor tasks, as well as global cognitive decline in older adults. We therefore contend that therapeutic strategies designed to increase alpha activity hold promise to improve dual-task standing performance, and many other cognitive-motor functions in older adults with and without MCI. To date, however, the effects of enhancing fronto-central alpha activity to improve dual-task balance in older adults with and without MCI have not been studied.
Transcranial alternating stimulation (tACS) is a safe, non-invasive brain stimulation technique that utilizes low-amplitude alternating currents to modulate brain activity and entrain specific cortical rhythms depending on the applied stimulation frequency. Targeting alpha band (10 Hz) in the frontal region has been shown to improve cognitive functioning in healthy older adults. However, no studies have investigated the effect of 10 Hz fronto-central stimulation on EEG alpha activity and postural sway outcomes during dual-task standing in older adults with and without MCI. We thus propose to conduct a within-subject cross-over, sham-controlled study in 30 older adults without an overt disease and 30 older adults with MCI. Participants will undergo dual-task standing and cognitive assessments immediately before and after single sessions of 10 Hz tACS (fronto-central alpha stimulation), and active-sham to understand the effect of different stimulation parameters on dual-task standing performance in older adults. We hypothesize that (1) older adults with MCI will demonstrate decreased EEG alpha power during dual-task standing compared to healthy controls, and decreased alpha power will be associated with worse balance outcomes during dual-task standing, and (2) compared to the pre-stimulation condition, participants will exhibit a greater increase in alpha power during the dual-task standing condition following tACS as compared to sham stimulation, and the increase in alpha power from pre-to-post tACS will correlate with a decrease in dual-task postural sway speed from pre-to-post tACS in older adults with and without MCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tACS | Active comparator | Other: real tACSThe investigators will administer the transcranial alternating current stimulation (tACS) intervention at 10 Hz to the participants. This intervention will utilize 6 electrodes; electrode placement and current parameters for each electrode have been optimized using a standard brain to generate an average electric field of 0.25 V/m. To ensure adherence to current safety recommendations for tACS, optimizations will be constrained to a maximum of total injected current 4.0 mA and a max. current per electrode of 2.0 mA. Stimulation will start and end with a 60 s ramp up/down to maximize comfort. This standard approach is both well-tolerated and safe in older adults. In a separate visit, we will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. |
| sham tACS | Sham comparator | Other: sham tACSThe investigators will administer the sham tACS intervention to the participants. They will use an active sham in which very low-level alternating currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- Our target population will be healthy older men and women who are cognitively intact. We will also ensure that participants are not so impaired that they cannot safely participate nor potentially benefit from the intervention.
- Age 65+ without any cognitive impairment (based in MoCA or TICS)
- Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained able and willing to comply with all study requirements informed consent form was signed
- Ability to stand and walk independently
- Understanding of the informed consent form (ICF) will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
Key exclusion criteria (17 listed)
- Exclusion Criteria have been selected to ensure safety and optimize compliance while minimizing confounds due to overt disease or conditions that may significantly influence study outcomes.
- Potentially eligible individuals will complete the Montreal Cognitive Assessment (MoCA) - score < 26
- Major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
- Self-reported diagnosis of Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, history of stroke or other neurodegenerative disorder.
- Self-reported active cancer for which chemo-/radiation therapy is being received.
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 |
|---|---|---|
| real tACSThe participant will receive one session of 10 Hz tACS for 20-minutes | Other | real tACS |
| sham tACSThe participant will receive one session of active-sham tACS for 20-minutes | Other | sham tACS |
Primary outcome
EEG alpha-band power
Time frame: Change from immediately before and after each 20-minute session of tACS
EEG oscillations and frequency coupling at 8-13 Hz
Postural sway speed
Time frame: Change from immediately before and after each 20-minute session of tACS
This metric assesses the ability to control standing posture
5 secondary outcomes
Timed Up and Go Test (TUG)
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tACS
Postural sway area
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tACS
Postural sway path
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tACS
EEG theta-band power
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tACS
EEG beta-band power
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tACS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: Yes. The HSL Marcus Institute for Aging Research will promote the development of new research and new investigators by making the data available to outside investigators. The database will include demographic, clinical, functional, and neurophysiologic data from all participants. All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.
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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.
Melike Kahya principal investigator
Marcus Institute for Aging Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real tACS in people with Aging and Mild Cognitive Impairment, run by Hebrew SeniorLife 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 14 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 15 Mar 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole LaGanke (617-971-5358, nicolelaganke@hsl.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG alpha-band power (time frame: Change from immediately before and after each 20-minute session of tACS). The study lists 2 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 15 Mar 2023.