tDCS and Cognitive Training for Mild Cognitive Impairment and Alzheimer's Dementia

NCT04507815 | Unknown FDA Device

• 1 other identifier: VAM-20-00623
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

There are currently no disease-modifying treatments for cognitive and behavioral symptoms associated with early clinical Alzheimer's disease (AD), and only minimally effective symptomatic treatments are available. In this application, we propose a transcranial direct current stimulation (tDCS) augmented executive functioning training intervention. This intervention will target cognition and brain circuits that are impaired in patients with mild cognitive impairment (MCI) and early AD. The goal is to improve cognitive performance and functional outcomes in patients with MCI and early AD.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Change in Brief Test of Adult Cognition by Telephone (BTACT)

  Differences in magnitude of change in BTACT scores between active tDCS and sham groups from baseline to follow-up sessions. BTACT covers five cognitive domains: episodic verbal memory (list learning), working memory span (digits backwards), executive functioning (verbal fluency), inductive reasoning (number series completion), and processing speed (backwards counting). Higher total score on the BTACT indicates better cognitive performance.

  Change between baseline and 3 week follow-up; 3 and 6 months following study baseline

Study Arms (2)

Active tDCS

EXPERIMENTAL

Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes).

Device: Active Transcranial Direct Current Stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This ramp up/down method is done at the end of the stimulation period, as well. This method mimics the physical sensation of stimulation typically encountered at the very beginning and end of the intervention period.

Device: Sham Transcranial Direct Current Stimulation (tDCS)

Interventions

Active Transcranial Direct Current Stimulation (tDCS) DEVICE

Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.

Active tDCS

Sham Transcranial Direct Current Stimulation (tDCS) DEVICE

Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).

Sham tDCS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be included in the study if they:
• are a Veteran receiving services from the MVAHCS GRECC clinic
• have a clinical diagnosis of AD, MCI, or Mild Neurocognitive Disorder presenting as early AD type (predominantly amnestic and dysexecutive)
• are age 60 or older
• are stable on any medications for at least 1 month at the baseline visit
• demonstrate capacity to provide informed consent
• have WiFi access in their home
• have a family member or friend willing to serve as a care partner (care partner needs to have a minimum of 10 hours per week that they see the participant, if they don't live with them).

You may not qualify if:

• Persons will be excluded from this study if they have:
• any significant medical disorder based on the Principal Investigator's judgment that would impact risk
• other psychiatric or neurological conditions that impact cognition
• metallic cranial plates/screws or implanted devices above the clavicle
• eczema on scalp or other scalp lesions or skin disorders that may become irritated by stimulation

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead

Study Sites (1)

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• John R McCarten, MD

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John R McCarten, MD

CONTACT

612-467-3314; Riley.McCarten@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 11, 2020
• Study Start: September 24, 2020
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)