Mild Cognitive ImpairmentCOBALTNCT05564715

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

A study testing NeuroElectric StarStim in people with Mild Cognitive Impairment and Amnestic Mild Cognitive Impairment - aMCI, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 years and older
Conditions the study is for: Mild Cognitive Impairment, Amnestic Mild Cognitive Impairment - aMCI
What is being tested?: NeuroElectric StarStim
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 1 May 2023to 3 Jun 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions: Mild Cognitive Impairment, Amnestic Mild Cognitive Impairment - aMCI
Being tested: NeuroElectric StarStim, Sham Treatment
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NeuroElectric StarStimDevice
Also called Phase 1/2 Active
10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks
Sham TreatmentDevice
Sham stimulation for 10 sessions over 2 weeks

Study groups in NCT05564715
Study group	Role	What they receive
Phase 1: Active Treatment	Active comparator	Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) 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 Receives: Device: NeuroElectric StarStim
Phase 1: Sham Treatment	Sham comparator	Participants will receive 10 sessions of sham stimulation 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 Receives: Device: Sham Treatment
Phase 2: Active Treatment	Active comparator	For Phase 2, participants randomized into the sham group will have the opportunity to return after 2 months from completing Phase 1. They will 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. Receives: Device: NeuroElectric StarStim

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Rey Auditory Verbal Learning Test Score
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
Measured: Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment

Secondary outcomes (2)

Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test
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
Measured: Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment
Changes in Boston Naming Test Short Form
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
Measured: Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20233 Jun 2025

First posted3 Oct 2022
Study start1 May 2023
Primary completion3 Jun 2025
Study completion3 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: In Phase 1, there will be two treatment arms (active and sham). All subjects will have the option to complete active stimulation of HD-tDCS. Those assigned to the sham condition group will have the option to return for active treatment in Phase 2. Each HD-tDCS condition is comprised of 10 days of active or sham stimulation targeting the pre-SMA (supplemental motor area)/sACC (subgenual anterior cingulate cortex) followed by neuropsychological testing after completion of the last session.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05564715
Sponsor's protocol ID: STU-2022-0799
Acronym: COBALT
Status last verified: Jul 2026
First submitted: 27 Sep 2022
Last updated: 7 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mild Cognitive Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive Outcomes of Brain Stimulation As a Later-in-Life Treatment
ClinicalTrials.gov ID: NCT05564715
Acronym / sponsor ID: COBALT / STU-2022-0799
Conditions: Mild Cognitive Impairment, Amnestic Mild Cognitive Impairment - aMCI
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: Texas Alzheimer's Research and Care Consortium
Study start: 1 May 2023 (actual)
Primary completion: 3 Jun 2025 (actual)
Study completion: 3 Jun 2025 (actual)
First posted: 3 Oct 2022 (actual)
Results: Posted 12 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
Model description: In Phase 1, there will be two treatment arms (active and sham). All subjects will have the option to complete active stimulation of HD-tDCS. Those assigned to the sham condition group will have the option to return for active treatment in Phase 2. Each HD-tDCS condition is comprised of 10 days of active or sham stimulation targeting the pre-SMA (supplemental motor area)/sACC (subgenual anterior cingulate cortex) followed by neuropsychological testing after completion of the last session.

Arm	Type	Receives
Phase 1: Active Treatment	Active comparator	Device: NeuroElectric StarStimParticipants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) 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
Phase 1: Sham Treatment	Sham comparator	Device: Sham TreatmentParticipants will receive 10 sessions of sham stimulation 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
Phase 2: Active Treatment	Active comparator	Device: NeuroElectric StarStimFor Phase 2, participants randomized into the sham group will have the opportunity to return after 2 months from completing Phase 1. They will 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 may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NeuroElectric StarStimAlso: Phase 1/2 Active10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks	Device	Phase 1: Active Treatment, Phase 2: Active Treatment
Sham TreatmentSham stimulation for 10 sessions over 2 weeks	Device	Phase 1: Sham Treatment

Primary outcome

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

2 secondary outcomes

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
Changes in Boston Naming Test Short Form
Time frame: Pre-treatment, post-treatment (immediately following last HD-tDCS session), and 8 weeks post-treatment

Results and safety

Results posted to the registry on 12 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: Active Treatment	13	12
Phase 1: Sham Treatment	12	12

Primary outcome: 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. Mean (Standard Deviation). Unit: T-score on a scale

Measure	Phase 1: Active Treatment n = 12	Phase 1: Sham Treatment n = 12	Phase 2: Sham-to-Active Treatment n = 10
Baseline Total Learning	34.1 (11.0)	33.3 (9.3)	34.7 (11.2)
Baseline Delayed Recall	28.9 (10.5)	32.1 (10.8)	30.1 (9.1)
Post-treatment Total Learning	35.7 (12.4)	33.0 (10.5)	33.3 (11.7)
Post-treatment Delayed Recall	32.8 (12.5)	29.8 (10.8)	28.1 (8.0)
2 Months Post Total Learning	35.1 (9.4)	34.2 (10.2)	34.6 (12.1)
2 Months Post Delayed Recall	30.3 (7.9)	29.9 (8.4)	30.8 (12.0)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored from the start of assigned treatments (1 mA and sham) through study completion, up to 10 weeks. This involved collection of information about adverse effects daily at the beginning and end of each treatment session and then again at the 2-month follow-up visit. Participants who were assigned sham during Phase 1 and returned to receive active treatment during an open-label phase were monitored for adverse events following the same approach.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: Active Treatment	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Phase 1: Sham Treatment	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Phase 2: Sham-to-Active Open Label Treatment	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05564715.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.