RECRUITING

Modulating Cortical Dynamics of Dual-task Standing in MCI

Conditions

Aging Mild Cognitive Impairment non-invasive brain stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Understanding and Modulating Cortical Dynamics of Dual-task Standing in Older Adults With Mild Cognitive Impairment

Quick Facts

Study Start:2023-03-13

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05680701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 95 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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.	* 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 * 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.

Inclusion Criteria

Exclusion Criteria

* 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.
* 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.

* 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
* 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.

Contacts and Locations

Study Contact

Nicole LaGanke

CONTACT

617-971-5358

nicolelaganke@hsl.harvard.edu

Kathy Tasker

CONTACT

6179715351

kathytasker@hsl.harvard.edu

Principal Investigator

Melike Kahya

PRINCIPAL_INVESTIGATOR

Marcus Institute for Aging Research

Study Locations (Sites)

Marcus Institute for Aging Research

Boston, Massachusetts, 02131

United States

Collaborators and Investigators

Sponsor: Hebrew SeniorLife

Melike Kahya, PRINCIPAL_INVESTIGATOR, Marcus Institute for Aging Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-13

Study Completion Date2025-01

Study Record Updates

Study Start Date2023-03-13

Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

aging
mild cognitive impairment
non-invasive brain stimulation

Additional Relevant MeSH Terms

Aging
Mild Cognitive Impairment