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Brain Stimulation
Brain Stimulation for Mild Cognitive Impairment
N/A
Recruiting
Led By Melike Kahya
Research Sponsored by Hebrew SeniorLife
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from immediately before and after each 20-minute session of tacs
Awards & highlights
Study Summary
This trial will test if a single session of brain stimulation can improve standing, walking, and thinking in older people with or without mild cognitive impairments. 60 people are taking part.
Who is the study for?
This trial is for adults aged 65 and older, both with and without mild cognitive impairments (MCI), who can stand and walk on their own. Participants must have a MOCA score above 18, be able to understand the study's consent form, and agree to all requirements. Those with major psychiatric disorders, active cancer under treatment, recent severe illness or injury affecting mobility, neurodegenerative diseases other than MCI, or contraindications to brain stimulation are excluded.Check my eligibility
What is being tested?
The study is examining the effects of transcranial alternating current stimulation (tACS) on standing balance, walking ability, and cognitive function in older adults. It compares real tACS against a sham (placebo-like) intervention in about 60 participants to see if it improves these functions in those with or without MCI.See study design
What are the potential side effects?
While tACS has been used safely in many individuals before this trial does not explicitly list potential side effects; however common ones from similar studies may include mild headache or discomfort at the electrode sites during application.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from immediately before and after each 20-minute session of tacs
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from immediately before and after each 20-minute session of tacs
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
EEG alpha-band power
Postural sway speed
Secondary outcome measures
EEG beta-band power
EEG theta-band power
Postural sway area
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: real tACSActive Control1 Intervention
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.
Group II: sham tACSPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Hebrew SeniorLifeLead Sponsor
45 Previous Clinical Trials
270,496 Total Patients Enrolled
14 Trials studying Aging
3,816 Patients Enrolled for Aging
Melike KahyaPrincipal InvestigatorMarcus Institute for Aging Research
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can stand and walk on my own.I am currently receiving chemotherapy or radiation for my cancer.I understand the study, can consent to it, and will follow all its requirements.My MOCA score is 18 or higher.I do not have major depression, schizophrenia, or psychosis.I am willing and able to follow all study requirements.I cannot walk 25 feet without help.I am an older adult and have been diagnosed with specific health conditions.I understand the study and agree to participate.I do not have major depression, schizophrenia, or psychosis.I am over 65 and do not have any cognitive issues.I am an older adult without specific disabilities or conditions that prevent tACS.I am an older adult currently receiving treatment for my active cancer.I can stand and walk on my own.I have had a stroke or a brain disorder other than mild cognitive impairment.I have conditions that prevent me from undergoing tACS due to my age.I was hospitalized recently due to an illness or injury that has made it hard for me to walk or keep my balance.My MOCA score is above 18.I am 65 or older with a mild cognitive impairment diagnosis.
Research Study Groups:
This trial has the following groups:- Group 1: real tACS
- Group 2: sham tACS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study open to octogenarians?
"The current recruitment drive is targeting elderly individuals aged 65 and up to 95."
Answered by AI
What is the cohort size of this clinical research trial?
"Affirmative. Clinicaltrials.gov indicates that recruitment is underway for this experiment, which was initially uploaded on March 13th 2023 and last modified on the same date. This trial requires 60 participants from a single medical facility."
Answered by AI
Is enrollment for this scientific research still open?
"This clinical trial, listed on clinicaltrials.gov since March 13th 2023, is actively recruiting participants for the study. It was most recently updated on that same date."
Answered by AI
What are the underlying aims of this clinical investigation?
"The primary outcome assessed during this trial, which involves the administration of tACS over 20 minute intervals, is postural sway speed. Secondary metrics are also evaluated including postural sway area and path along with EEG-derived theta band power."
Answered by AI
Is enrollment in this research study still open?
"This trial is open to elderly individuals aged 65 or older who have been diagnosed with cognitive impairment. To qualify for participation, patients must be healthy, mentally competent, and able to walk independently; as well as understand the informed consent form (ICF). Applicants will additionally be assessed based on their score in a Montreal Cognitive Assessment Test (MoCA) which should exceed 18 points. Finally, those wishing to take part need to agree and comply with all study requirements stated in the ICF."
Answered by AI
Who else is applying?
What state do they live in?
Kansas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
How responsive is this trial?
Typically responds via
Phone Call
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