Recruiting

tDCS & Cognitive Training

Sponsor:

Minneapolis Veterans Affairs Medical Center

Code:

NCT04507815

Conditions

Alzheimer Disease

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Active Transcranial Direct Current Stimulation (tDCS)

Sham Transcranial Direct Current Stimulation (tDCS)

Study Details

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

Study ID

NCT04507815

Start date

Sep 24, 2020

Status verified date

Mar, 2023

Completion date

Sep, 2024

Anticipated

Primary completion date

Mar, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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).

Exclusion Criteria:

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active tDCS

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).

sham comparator: Sham tDCS

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.

Interventions

Active Transcranial Direct Current Stimulation (tDCS)

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

Sham Transcranial Direct Current Stimulation (tDCS)

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

Primary outcome measure

  • Change in Brief Test of Adult Cognition by Telephone (BTACT) [ Time Frame: Change between baseline and 3 week follow-up; 3 and 6 months following study baseline ]

Central Contacts and Locations

Central contacts

John R McCarten, MD

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

Locations

Minneapolis VA Health Care System

Recruiting

Minneapolis, Minnesota, United States, 55417

More Information

Sponsor

Minneapolis Veterans Affairs Medical Center

Last update posted

Mar 14, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Veterans Affairs Medical Center on 2023-03-14.