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

March 13, 2023 updated by: Casey Gilmore, PhD, Minneapolis Veterans Affairs Medical Center

Combined tDCS and Cognitive Training for Mild Cognitive Impairment (MCI) and Early Clinical Alzheimer's Type Dementia (CATD)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives 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.

Research Plan and Methods This study will recruit 50 Veterans with MCI or very early AD who are receiving outpatient services at the Minneapolis VA Health Care System (MVAHCS) Geriatric Research, Education, and Clinical Center (GRECC) Memory Loss Clinic. This study will be a double-blind, randomized, placebo (sham) controlled study. Participants will be randomly assigned to receive either active or sham tDCS, both paired with cognitive training tasks. Ten sessions of training/tDCS sessions (20 minutes of 2mA current stimulation with 45 minutes of cognitive training tasks) will occur over 2-3 weeks, performed at the participant's home. Participants will attend an in-person enrollment and training session prior to study intervention. Follow-up sessions will occur via phone or video conference at 3 and 6 months after study initiation.

Clinical Relevance Executive cognitive impairments in patients with MCI or early AD have been associated with poor decision-making ability and lack of insight, potentially leading to compromised job performance, financial mismanagement, increased personal safety risk, relationship stress, and poor medical treatment adherence. While disproportionate memory impairment is a hallmark of both conditions, there are compensatory strategies available to reduce disability associated with very early stage memory impairment in those who are otherwise cognitively intact. Compensatory strategies are much less effective for executive dysfunction, as the disability itself impairs one's ability to recognize when such strategies are needed and successfully employ them. Novel, well-tolerated, neuroplasticity-based interventions that can reduce executive impairment by targeting both cognitive control (an executive ability) and its underlying neural dysfunction are needed to improve cognitive outcomes, safety, and quality of life for patients with MCI or early AD. Knowledge gained from this study can inform the future development of clinical treatment approaches aimed at reducing risk and delaying out-of-home placement in Veterans with cognitive impairment.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Recruiting
        • Minneapolis VA Health Care System

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.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Device: 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 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.
Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minneapolis Veterans Affairs Medical Center

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 Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 7, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAM-20-00623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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