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Completed

NCT Number: NCT05564715

Cognitive Outcomes of Brain Stimulation As a Later-in-Life Treatment

This is a pilot study being done to attempt to improve episodic memory problems in persons with mild cognitive impairment (MCI). The pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (dACC) have been shown to play a role in episodic memory and language retrieval. Prior studies have suggested that neurostimulation targeting this region can improve episodic memory and word recall. The purpose of this study is to examine the efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/dACC region and its influence on word retrieval and other cognitive functions in patients with MCI. Entraining the preSMA/dACC circuit with 10 sessions of HD-tDCS will allow us to study whether neurostimulation may be an effective treatment.

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Key information

Conditions

Mild Cognitive Impairment Amnestic Mild Cognitive Impairment - aMCI Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

The research objective of this study is to examine the efficacy of HD-tDCS to the preSMa/DaCC region and its influence on word retrieval and other cognitive functions in patients with MCI after 10 sessions of HD-tDCS. There will be two treatment arms: active HD-tDCS (1 mA) and a sham group. For Phase 1, participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) or sham across 2 weeks. Word retrieval and other cognitive tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up. For Phase 2, participants randomized into the sham group will have the opportunity to return after 2 months and receive the active treatment while being unblinded to their treatment condition. Following 10 active treatment sessions, word retrieval and other cognitive tasks will again be completed immediately following the last HD-tDCS session and then a 2-month follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Active diagnosis of mild cognitive impairment, Female and male subjects, All races/ethnicities, Age 55 years and older, Fluent in English,

Exclusion criteria

Lifetime history of major neurologic syndromes (e.g., epilepsy, brain tumor, etc), Substance use disorder within the past year, Has metal fragments in skull/head, Current vision or hearing impairment that interferes with testing, Current medication use known to alter HD-tDCS reactivity

Treatment and study plan

NeuroElectric StarStim

Device

10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks

Other names: Phase 1/2 Active

Sham treatment

Device

Sham stimulation for 10 sessions over 2 weeks

Primary outcomes

  1. Changes in Rey Auditory Verbal Learning Test Score

    Time frame: Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment

    The RAVLT is a verbal episodic memory test that is sensitive to mesial and lateral verbal episodic memory circuit dysfunction. The primary outcome measure for this task is the total number of items immediately recalled during the learning trials and after the 30 minute delayed recall trial. Changes in scores from baseline to testing immediately following the completion of the condition will be examined as well as from baseline to 8 weeks post-treatment.

    RAVLT : Rey Auditory Verbal Learning Test, 0-15 raw score for each trial (5 total trials) to be added altogether to generate a total learning score. Delayed recall trial has a raw score range of 0-15. Scores were transformed into T-scores using demographic based normative data, providing a score range from 0-100; with higher scores reflect better performance

Secondary outcomes

  1. Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test

    Time frame: Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment

    The DKEFS Verbal Fluency Test is a measure of word retrieval. The task has 3 conditions each lasting 60 seconds, requiring the subject to name words by phonemes, semantic categories, and then switching between two semantic categories. The outcome measure for this task is the total words named for each of the 3 conditions. Changes in scores from baseline to testing immediately following the completion of each condition will be examined as well as from baseline to 8 weeks post-treatment.

    DKEFS: Delis-Kaplan Executive Function System Verbal Fluency Test, there are no specified limits for each trial, T-scores ranged from 20-80 across all 3 conditions; higher scores reflect better performance

  2. Changes in Boston Naming Test Short Form

    Time frame: Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment

    The Boston Naming Test Short Form has 30 pictures of common objects that upon seeing each picture, individuals need to name the object as soon as one can. The outcome measure for this task is the number of correctly named items. Changes in scores from baseline to testing immediately following the completion of condition will be examined as well as from baseline to 8 weeks post-treatment.

    BNT: Boston Naming Test - Short Form, 0-30 total raw score to be converted to a T-score, ranging from 20-80; higher scores reflect better performance

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Texas Alzheimer's Research and Care Consortium

Registry information

Acronym: COBALT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2022
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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