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

Official title

Multifocal Transcranial Current Stimulation for Cognitive and Motor Dysfunction in Dementia

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.

Detailed description

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.

Interventions

• Device Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active)
  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.
• Device Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham)
  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.
• Device Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham)
  Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator. Active tACS to the left angular gyrus and sham tDCS to the prefrontal cortex.
• Device Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (active)
  Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator. Sham tACS to the left angular gyrus and active tDCS to the prefrontal cortex.

Primary outcome measures

• Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall [Time frame: baseline, immediate post-intervention, 3 month follow up , 6 month follow up]
• Change in Dual Task Cost to Gait [Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up]

Secondary outcome measures (10)

• Change in Functional Activity Questionnaire [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 [Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up]
• Average E-field normal component (En) for left angular gyrus and prefrontal cortex [Time frame: immediate post-intervention]
• Change in Adjusted Trail Making Test performance [Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up]
• Change in Stroop test response latency [Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up]
• Change in Gait speed [Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up]
• Change in Stride time variability [Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up]
• Change in Short Physical Performance Battery total score [Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up]
• Change in 12-item Short Form Health Survey (SF-12) [Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up]
• Change in Average daily step count [Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Hinda and Arthur Marcus Institute for Aging Research — Boston

Identifiers

NCT: NCT05661084 · Pro00059707 · 1R01AG076708

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗