Trial Outcomes & Findings for Cognitive Outcomes of Brain Stimulation As a Later-in-Life Treatment (NCT NCT05564715)

Last Updated: 2026-08-07

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

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

Results posted on

2026-08-07

Participant Flow

Pre-assignment numbers refers to the number of people randomized into their arm after consenting but before starting intervention. This number could be different than the number enrolled and number started as some participants withdrew consent after the initial visit but before starting intervention. During this gap between consenting and withdrawal, they could have been randomized in anticipation of their intervention start timeframe.

Participant milestones

Participant milestones
Measure	Phase 1: Active Treatment 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks	Phase 1: Sham Treatment 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 Sham Treatment: Sham stimulation for 10 sessions over 2 weeks
Assigned to Treatment STARTED	13	12
Assigned to Treatment COMPLETED	12	12
Assigned to Treatment NOT COMPLETED	1	0
Started Treatment STARTED	12	12
Started Treatment COMPLETED	12	12
Started Treatment NOT COMPLETED	0	0
Follow-Up at 2 Months STARTED	12	12
Follow-Up at 2 Months COMPLETED	12	12
Follow-Up at 2 Months NOT COMPLETED	0	0
Phase 2: Started Open-label Treatment STARTED	0	10
Phase 2: Started Open-label Treatment COMPLETED	0	10
Phase 2: Started Open-label Treatment NOT COMPLETED	0	0
Phase 2: Follow-up at 2 Months STARTED	0	10
Phase 2: Follow-up at 2 Months COMPLETED	0	10
Phase 2: Follow-up at 2 Months NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1: Active Treatment 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks	Phase 1: Sham Treatment 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 Sham Treatment: Sham stimulation for 10 sessions over 2 weeks
Assigned to Treatment Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Phase 1: Active Treatment n=12 Participants 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks	Phase 1: Sham Treatment n=12 Participants 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 Sham Treatment: Sham stimulation for 10 sessions over 2 weeks	Phase 2: Sham-to-Active Treatment n=10 Participants 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks
Changes in Rey Auditory Verbal Learning Test Score Baseline Total Learning	34.1 T-score on a scale Standard Deviation 11.0	33.3 T-score on a scale Standard Deviation 9.3	34.7 T-score on a scale Standard Deviation 11.2
Changes in Rey Auditory Verbal Learning Test Score Baseline Delayed Recall	28.9 T-score on a scale Standard Deviation 10.5	32.1 T-score on a scale Standard Deviation 10.8	30.1 T-score on a scale Standard Deviation 9.1
Changes in Rey Auditory Verbal Learning Test Score Post-treatment Total Learning	35.7 T-score on a scale Standard Deviation 12.4	33.0 T-score on a scale Standard Deviation 10.5	33.3 T-score on a scale Standard Deviation 11.7
Changes in Rey Auditory Verbal Learning Test Score Post-treatment Delayed Recall	32.8 T-score on a scale Standard Deviation 12.5	29.8 T-score on a scale Standard Deviation 10.8	28.1 T-score on a scale Standard Deviation 8.0
Changes in Rey Auditory Verbal Learning Test Score 2 Months Post Delayed Recall	30.3 T-score on a scale Standard Deviation 7.9	29.9 T-score on a scale Standard Deviation 8.4	30.8 T-score on a scale Standard Deviation 12.0
Changes in Rey Auditory Verbal Learning Test Score 2 Months Post Total Learning	35.1 T-score on a scale Standard Deviation 9.4	34.2 T-score on a scale Standard Deviation 10.2	34.6 T-score on a scale Standard Deviation 12.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Phase 1: Active Treatment n=12 Participants 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks	Phase 1: Sham Treatment n=12 Participants 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 Sham Treatment: Sham stimulation for 10 sessions over 2 weeks	Phase 2: Sham-to-Active Treatment n=10 Participants 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks
Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test Baseline Letter Fluency	51.6 T-score on a scale Standard Deviation 9.6	49.9 T-score on a scale Standard Deviation 11.8	51.4 T-score on a scale Standard Deviation 12.0
Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test Baseline Category Fluency	41.1 T-score on a scale Standard Deviation 8.1	42.6 T-score on a scale Standard Deviation 12.6	39.2 T-score on a scale Standard Deviation 10.3
Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test Baseline Category Switching	37.7 T-score on a scale Standard Deviation 11.3	33.3 T-score on a scale Standard Deviation 8.8	31.5 T-score on a scale Standard Deviation 13.4
Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test Immediate Post Letter Fluency	53.0 T-score on a scale Standard Deviation 10.9	51.7 T-score on a scale Standard Deviation 11.6	50.7 T-score on a scale Standard Deviation 13.8
Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test Immediate Post Category Fluency	41.9 T-score on a scale Standard Deviation 12.4	41.8 T-score on a scale Standard Deviation 10.4	39.9 T-score on a scale Standard Deviation 12.6
Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test Immediate Post Category Switching	38.8 T-score on a scale Standard Deviation 9.4	32.8 T-score on a scale Standard Deviation 11.3	34.1 T-score on a scale Standard Deviation 11.9
Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test 2-Month Letter Fluency	52.4 T-score on a scale Standard Deviation 11.3	50.6 T-score on a scale Standard Deviation 11.4	49.9 T-score on a scale Standard Deviation 13.5
Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test 2-Month Category Fluency	40.8 T-score on a scale Standard Deviation 9.7	38.4 T-score on a scale Standard Deviation 9.8	38.7 T-score on a scale Standard Deviation 11.4
Changes in Delis Kaplan Executive Function System (DKEFS) Verbal Fluency Test 2-Month Category Switching	40.2 T-score on a scale Standard Deviation 10.6	33.2 T-score on a scale Standard Deviation 12.9	29.0 T-score on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Phase 1: Active Treatment n=12 Participants 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks	Phase 1: Sham Treatment n=12 Participants 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 Sham Treatment: Sham stimulation for 10 sessions over 2 weeks	Phase 2: Sham-to-Active Treatment n=10 Participants 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks
Changes in Boston Naming Test Short Form Immediate Post-treatment	36.8 T-score on a scale Standard Deviation 8.1	39.7 T-score on a scale Standard Deviation 12.4	41.0 T-score on a scale Standard Deviation 11.9
Changes in Boston Naming Test Short Form Baseline	35.9 T-score on a scale Standard Deviation 12.9	37.6 T-score on a scale Standard Deviation 9.8	39.3 T-score on a scale Standard Deviation 9.4
Changes in Boston Naming Test Short Form 2-Month Follow-Up	39.4 T-score on a scale Standard Deviation 12.1	41.3 T-score on a scale Standard Deviation 9.6	41.0 T-score on a scale Standard Deviation 11.7

Adverse Events

Phase 1: Active Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Phase 1: Sham Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 2: Sham-to-Active Open Label Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Phase 1: Active Treatment n=12 participants at risk 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks	Phase 1: Sham Treatment n=12 participants at risk 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 Sham Treatment: Sham stimulation for 10 sessions over 2 weeks	Phase 2: Sham-to-Active Open Label Treatment n=10 participants at risk 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks
Respiratory, thoracic and mediastinal disorders Acute infection	8.3% 1/12 • Number of events 1 • 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.	0.00% 0/12 • 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.	0.00% 0/10 • 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.
Cardiac disorders Symptomatic poor blood pressure	8.3% 1/12 • Number of events 1 • 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.	0.00% 0/12 • 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.	0.00% 0/10 • 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.

Additional Information

Christian LoBue, PhD and Hsueh-Sheng Chiang, MD, PhD

UT Southwestern Medical Center

Phone: 2146484658

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase 1: Active Treatment n=12 Participants 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 NeuroElectric StarStim: 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks	Phase 1: Sham Treatment n=12 Participants 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 Sham Treatment: Sham stimulation for 10 sessions over 2 weeks	Total n=24 Participants Total of all reporting groups
Age, Continuous	74.0 years STANDARD_DEVIATION 7.5 • n=20 Participants	73.2 years STANDARD_DEVIATION 5.7 • n=20 Participants	73.6 years STANDARD_DEVIATION 6.5 • n=40 Participants
Sex: Female, Male Female	6 Participants n=20 Participants	6 Participants n=20 Participants	12 Participants n=40 Participants
Sex: Female, Male Male	6 Participants n=20 Participants	6 Participants n=20 Participants	12 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=20 Participants	11 Participants n=20 Participants	23 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) White	12 Participants n=20 Participants	12 Participants n=20 Participants	24 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Region of Enrollment United States	12 participants n=20 Participants	12 participants n=20 Participants	24 participants n=40 Participants
Education	16.3 years STANDARD_DEVIATION 2.2 • n=20 Participants	16.2 years STANDARD_DEVIATION 2.3 • n=20 Participants	16.3 years STANDARD_DEVIATION 2.2 • n=40 Participants