Non-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia

Hebrew SeniorLife144 enrolled

Overview

This project aims to examine the efficacy of remote, caregiver-led tES/brain stimulation intervention targeted to improve memory, mobility, and executive functioning among older adults with mild cognitive impairment or mild dementia.

This is a randomized controlled trial to test the efficacy of a home-based brain stimulation intervention of tACS (for angular gyrus) and tDCS (for the prefrontal cortex) to improve memory, mobility, and executive function. It will include 144 older adults with mild dementia or mild cognitive impairment and their caregiver/administrator who will be trained to lead the remote, home-based brain stimulation. Participants will be randomized into one of four conditions, a) active combination of tACS + tDCS, b) combination of active tACS + sham tDCS, c) combination of sham tACS + active tDCS, and d) combination of sham tACS + sham tDCS. Participants will engage in a set of pre-intervention assessments, the brain stimulation intervention--consisting of 20, once-daily 30-min stimulation sessions administered over a 4-week period, and a set of post-intervention assessments (immediately following brain stimulation, 3 months post-brain stimulation, and 6 months post-brain stimulation). This project is expected to demonstrate that tACS and tDCS can be combined to optimize the functional impact of a home-based tES intervention for older adults with mild dementia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

144

Conditions

Dementia Memory Loss Alzheimer Disease Executive Dysfunction Mobility Limitation

Interventions

Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active)DEVICE

Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator to the left angular gyrus and prefrontal cortex.

Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham)DEVICE

A sham transcranial electrical stimulation (tES) will be administered to the participant in their home by their caregiver administrator to the left angular gyrus and prefrontal cortex. It will physically mimic active stimulation.

Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham)

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: Participants (Ps) * 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 * an informed consent form was signed * able to read, write, and communicate in English Caregiver/Administrators (As) * at least 18 years of age * able to read, write, and communicate in English * self-reported computer proficiency and willingness to learn how to use tES as defined by "yes" answers to the questions "Do you feel comfortable using a computer?" and "Are you willing to be the primary caregiver for a participant and learn how to administer tES?" * stated availability during weekdays throughout the study period to administer tES to the Ps Exclusion Criteria: Participants (Ps) * major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis * blindness or other disabilities that prevent task performance * contraindications to tES, 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, etc.) * the presence of any active dermatological condition, such as eczema, on the scalp a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen * an inability to understand study procedures following review of the Informed Consent form * Understanding 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 Caregiver/Administrators (As) * mild cognitive impairment defined by a MoCA score ≤26 during the in-person screen * insufficient understanding of study procedures following review of the Informed Consent form * Understanding 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. * poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tES

Locations (1)

Hinda and Arthur Marcus Institute for Aging Research

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall

This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time. Total recall is measured by the total number of words out of 15 the participant is able to recall. Scores range from 0 to 15.

Time frame: baseline, immediate post-intervention, 3 month follow up , 6 month follow up

Change in Dual Task Cost to Gait

This measure is captured by Mobility Lab™ (APDM Inc) software while the participant is walking with sensors at a) normal speed (speed for single task) and b) walking while counting backwards by 3's or 1's (speed dual task). The formula for cost of the dual task to gait is: (speedsingletask-speeddualtask)/speedsingletask)\*100). Range for dual task cost is as follows: High Risk for falls \> 0.2, Moderate Risk for falls \<= 0.2, Low Risk \< 0.1.

Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up

Secondary Outcomes

Change in Functional Activity Questionnaire

This is a 10-item scale to measure functional status via independent activities of daily living. Each item is a functional activity, and the caregiver/informant rates the participant's ability using the following scoring system: * Dependent = 3 * Requires assistance = 2 * Has difficulty but does by self = 1 * Normal = 0 * Never did \[the activity\] but could do now = 0 * Never did and would have difficulty now = 1 The scores are summed (range 0-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. This test will be used to track functional status over the course of the intervention and follow-up.

Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up

Change in Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores

The Montreal Cognitive Assessment (MoCA) is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains. The total possible score is 30 points; a score of 26 or above is considered normal. Severity of impairment can be determined with the following scores: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment. The maximum total score is 30 and the minimum total score is 0 points. The memory and executive subscales are each on a range of 0 to 5 points.

Central Contacts

HomeStim Study

CONTACT

617-971-5416 homestim@hsl.harvard.edu

Data from ClinicalTrials.gov

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