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NCT04817891 · ClinicalTrials.gov registry record · NA
Stimulation of Cingulo-opercular Alertness Network
A NA study of Lewy Body Disease and Lewy Body Dementia With Behavioral Disturbance, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04817891: Completed NA study of Lewy Body Disease and Lewy Body Dementia With Behavioral Disturbance, sponsored by University of Michigan.
NCT04817891 is a NA study of Lewy Body Disease and Lewy Body Dementia With Behavioral Disturbance that has completed, run by University of Michigan. The registered enrollment target is 15 participants, below the 483-participant average among 6 other Lewy Body Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04817891, a NA study of Lewy Body Disease and Lewy Body Dementia With Behavioral Disturbance, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 in
Conditions Studied
Interventions
- DEVICE HD-tDCS
Study Locations (1)
Michigan
- 4250 Plymouth Road (University of Michigan) - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2024-08-26 |
| Phase | NA |
What the finished NCT04817891 record still lists
NCT04817891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 483-participant average among 6 other Lewy Body Disease trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Lewy Body Disease appearing as the primary indexed condition, and to 1 intervention - of which HD-tDCS is the first listed.
NCT04817891 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04817891 about?
NCT04817891 is a clinical study titled "Stimulation of Cingulo-opercular Alertness Network". 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 ...
What is the current status of trial NCT04817891?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2021-05-03. Estimated completion is 2024-08-26.
What conditions does trial NCT04817891 study?
This clinical trial studies the following conditions: Lewy Body Disease, Lewy Body Dementia With Behavioral Disturbance, Lewy Body Variant of Alzheimer Disease.
What interventions are being tested in trial NCT04817891?
The interventions under investigation include: HD-tDCS (DEVICE).
Who is sponsoring clinical trial NCT04817891?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04817891 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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