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Stimulation of Cingulo-opercular Alertness Network

NCT04817891 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-10-22

Study results available
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Summary

Fluctuations in alertness are very common in persons with Lewy body dementias and are a major source of disability. Changes in a chemical messenger molecule called acetylcholine within certain brain regions may play a role in these fluctuations. We propose to test this hypothesis and also determine whether a non-invasive way of stimulating affected brain regions may be of relevance for future management of these fluctuations.

Conditions

  • Lewy Body Disease
  • Lewy Body Variant of Alzheimer Disease
  • Lewy Body Dementia With Behavioral Disturbance

Interventions

DEVICE

HD-tDCS

Participants will receive HD-tDCS at up to 4 mA per channel for 20 minutes for 10 sessions. Dose determined through individualized computational models.

Sponsors & Collaborators

Principal Investigators

  • Benjamin Hampstead, PhD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2024-08-26
Completion
2024-08-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04817891 on ClinicalTrials.gov