Modulating Cortical Dynamics of Dual-task Standing in MCI

NCT05680701 | Unknown

• 1 other identifier: Pro00067596
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Aging; Mild Cognitive Impairment

Keywords

aging; mild cognitive impairment; non-invasive brain stimulation

Outcome Measures

Primary Outcomes (2)

• EEG alpha-band power

  EEG oscillations and frequency coupling at 8-13 Hz

  Change from immediately before and after each 20-minute session of tACS

• Postural sway speed

  This metric assesses the ability to control standing posture

  Change from immediately before and after each 20-minute session of tACS

Secondary Outcomes (5)

• Timed Up and Go Test (TUG)

  This outcome will be assessed immediately before and after each 20-minute session of tACS

• Postural sway area

  This outcome will be assessed immediately before and after each 20-minute session of tACS

• Postural sway path

  This outcome will be assessed immediately before and after each 20-minute session of tACS

• EEG theta-band power

  This outcome will be assessed immediately before and after each 20-minute session of tACS

• EEG beta-band power

  This outcome will be assessed immediately before and after each 20-minute session of tACS

Study Arms (2)

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.

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.

Other: sham tACS

Interventions

real tACS OTHER

The participant will receive one session of 10 Hz tACS for 20-minutes

real tACS

sham tACS OTHER

The participant will receive one session of active-sham tACS for 20-minutes

sham tACS

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Healthy older adults:
• 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.
• 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.

Sponsors & Collaborators

• Hebrew SeniorLife: lead

Study Sites (1)

Marcus Institute for Aging Research

Boston, Massachusetts, 02131, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Melike Kahya

  Marcus Institute for Aging Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole LaGanke

CONTACT

617-971-5358; nicolelaganke@hsl.harvard.edu

Kathy Tasker

CONTACT

6179715351; kathytasker@hsl.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 11, 2023
• Study Start: March 13, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 15, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The investigators will make the data and associated documentation available once summary data are published or otherwise made available, starting six months after publication.
• Access Criteria: The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: 1) a commitment to using data only for research purposes and not to identify any particular 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. The availability of data will be advertised over the Internet through websites maintained by Hebrew SeniorLife and Harvard Medical School. All investigators wishing to access the data will submit a brief proposal describing their research project, data needs, regulatory approvals, and mechanisms to assure patient confidentiality. Upon affirmative review by the Principal Investigator and co-investigators of this study, a data-sharing agreement will be signed and the requesting investigators will be given a working data file and appropriate documentation.

Locations

US (1)