Trial · NCT04817891

Stimulation of Cingulo-opercular Alertness Network

NCT04817891, Not applicable, Completed, University of Michigan; results first posted 2025-10-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Stimulation of Cingulo-opercular Alertness Network. Trials, record NCT04817891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04817891

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Stimulation of Cingulo-opercular Alertness Network
NCT number: NCT04817891
Status: Completed
Phases: Not applicable
Enrollment: 15 participants, actual
Lead sponsor: University of Michigan
Conditions: Lewy Body Disease, Lewy Body Variant of Alzheimer Disease, Lewy Body Dementia With Behavioral Disturbance
Interventions: HD-tDCS
First posted: 2021-03-26
Last updated: 2025-10-22
Results first posted: 2025-10-22

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Dementia Cognitive Fluctuations Scale	Baseline and Post-Testing (3-4 weeks)	Score on a 4-item subscale of the 17-item Dementia Cognitive Fluctuation Scale (DCFS), developed to address limitations in prior scales and has good test-retest and inter-rater reliability; this subscale highly discriminates between dementia with Lewy bodies (DLB) and other dementia groups. The DCFS is a subjective report of cognitive fluctuation, the spontaneous change in cognitive ability which is a core diagnostic feature of DLB. Total subscale scores range from 4 to 20, with higher scores indicating greater cognitive fluctuations. A decrease in score between Baseline and Post-Testing indicates an improvement in cognitive fluctuation.
Secondary	Resting State fMRI	Baseline and Post-Testing (3-4 weeks)	Functional connectivity measures whether activity in different brain regions show similar patterns of change over time. Graph theory metrics of resting-state fMRI can characterize functional connectivity among nodes (regions) of a brain network, and well as between nodes of different brain networks. Network segregation is the difference of within-network and between-network connectivity as a proportion of within-network connectivity, such that higher numbers reflect more segregation. Given that network segregation typically decreases with normal and pathological aging, higher network segregation is generally considered cognitively beneficial. Network segregation was examined for the ventral attention network (the actual focus of stimulation based on observed cholinergic denervation) and the original cingulo-opercular network, which was predicted at the time of grant proposal (but not supported by the observed cholinergic denervation).
Secondary	Stroop Color Word Interference Test - Cognitive Control Performance	Baseline, 3-4 weeks	Outcome Measure Description: Interference score in time to complete the Color Word Interference Test version of the Stroop task from the Delis-Kaplan Executive Function System. Participants 1) identify a series of colors, 2) read color words (e.g. blue) all written in black ink, and 3) name the ink color of color words printed in incongruous colored inks (e.g. for the word "green" written in red ink, the correct response is "red"). Tasks are performed as quickly as possible. Time to complete each task is recorded. Interference score is calculated as the time to complete the color-word (interference) test (CWT), less the average of the time to complete the color task (CT) and word-reading task (WT): CWT - ((CT + WT)/2). The score has a theoretical valid range of 0 - 300; a lower score suggests better cognitive control. A negative change (decrease) in score between Baseline and Post-Testing indicates improvement in cognitive control performance.
Secondary	Objective Measures of Working Memory (N-back Test)	Baseline, 3-4 weeks	The n-back test is a working memory task where a participant identify a stimulus that matches the stimulus experienced "n" steps back. Participants performed a 2-back test, in which they were asked to remember and press a button when presented with a stimulus that appeared two steps before the current one (e.g. square, circle, square). The number of correct and incorrect identifications are normalized (z-score). Total score is the z-score of correct button presses minus the z-score of incorrect button presses. Possible scores range from -4.85 to 4.85. A higher score (d') reflects better discrimination between target and non-target stimuli, and therefore better working memory performance. A positive change (increase) in 2-back score (d') between Baseline and Post-Testing indicates an improvement in working memory performance.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Dementia Cognitive Fluctuations Scale	Baseline and Post-Testing (3-4 weeks)	Data is reported for participants who completed both baseline and week 3/4 measures.	score on a scale	MEAN
SECONDARY	Resting State fMRI	Baseline and Post-Testing (3-4 weeks)	Ten participants completed resting-State fMRI at Baseline and Post-Testing. Two participants were not eligible for MRI.	ratio of network segregation	MEAN
SECONDARY	Stroop Color Word Interference Test - Cognitive Control Performance	Baseline, 3-4 weeks	8 participants completed the Color Word Interference Test at Baseline and Post-Testing. 4 participants did not complete the test. Negative scores are technically possible, but given the known robust and reliable cognitive effort required in color word interference, a negative interference score would call into question the validity of the administration and be excluded. No participants' scores were negative and therefore none were excluded for this reason..	calculated score	MEAN
SECONDARY	Objective Measures of Working Memory (N-back Test)	Baseline, 3-4 weeks	12 participants completed the n-back working memory task at both Baseline and Post-Testing, however one participant used an incorrect button to make responses at Baseline, so these responses were not recorded, leaving 11 participants with recorded data at Baseline and Post-Testing. Of these 11, 5 performed below chance (\<50% hit rate) on the control task at one or both timepoints and were excluded from analysis.	calculated score	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Dementia Cognitive Fluctuations Scale	Experimental: HD-tDCS	Baseline	11.75	Standard Deviation 3.31	score on a scale
Dementia Cognitive Fluctuations Scale	Experimental: HD-tDCS	Week 3/4	8.33	Standard Deviation 1.56	score on a scale
Resting State fMRI	Experimental: HD-tDCS	Baseline - Ventral Attention Network	0.23	Standard Deviation 0.17	ratio of network segregation
Resting State fMRI	Experimental: HD-tDCS	3/4 weeks - Ventral Attention Network	0.33	Standard Deviation 0.10	ratio of network segregation
Resting State fMRI	Experimental: HD-tDCS	Baseline - Cingulo-opercular network	0.53	Standard Deviation 0.11	ratio of network segregation
Resting State fMRI	Experimental: HD-tDCS	3/4 weeks - Cingulo-opercular network	0.53	Standard Deviation 0.11	ratio of network segregation
Stroop Color Word Interference Test - Cognitive Control Performance	Experimental: HD-tDCS	Baseline	143.44	Standard Deviation 51.89	calculated score
Stroop Color Word Interference Test - Cognitive Control Performance	Experimental: HD-tDCS	3-4 weeks	125.15	Standard Deviation 52.91	calculated score
Objective Measures of Working Memory (N-back Test)	Experimental: HD-tDCS	Baseline	0.94	Standard Deviation 0.72	calculated score
Objective Measures of Working Memory (N-back Test)	Experimental: HD-tDCS	3-4 weeks	1.24	Standard Deviation 0.60	calculated score

Source ClinicalTrials.gov

Participant flow4

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Experimental: HD-tDCS	15
Overall Study	Began Study Treatment	Experimental: HD-tDCS	13
Overall Study	COMPLETED	Experimental: HD-tDCS	12
Overall Study	NOT COMPLETED	Experimental: HD-tDCS	3

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Progression of preexisting delusions related to Lewy Body Dementia disease progression	Nervous system disorders	Experimental: HD-tDCS	1	13
other	Itching	Skin and subcutaneous tissue disorders	Experimental: HD-tDCS	7	13
other	Worsening of dizziness upon standing post treatment	General disorders	Experimental: HD-tDCS	1	13
other	Burning sensation	Skin and subcutaneous tissue disorders	Experimental: HD-tDCS	13	13
other	Tingling	General disorders	Experimental: HD-tDCS	13	13
other	Scalp Pain	Skin and subcutaneous tissue disorders	Experimental: HD-tDCS	7	13
other	Trouble Concentrating	General disorders	Experimental: HD-tDCS	5	13
other	Sleepiness	General disorders	Experimental: HD-tDCS	8	13
other	Headache	General disorders	Experimental: HD-tDCS	3	13
other	Acute Mood Change	General disorders	Experimental: HD-tDCS	2	13

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Experimental: HD-tDCS	0	13
Total, other adverse events	Experimental: HD-tDCS	13	13
Total, serious adverse events	Experimental: HD-tDCS	0	13

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21AG069387	Cholinergic functions and modulation of the cingulo-opercular alertness network in LBD	BOHNEN, NICOLAAS IDA; HAMPSTEAD, BENJAMIN MICHAEL	UNIVERSITY OF MICHIGAN AT ANN ARBOR	NATIONAL INSTITUTE ON AGING	2020

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests3

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
1-Back Task	Secondary outcome	ConductCognition
2-Back Task	Secondary outcome	ConductCognition
Stroop Color-Word Test	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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