NCT04817891Completed
Stimulation of Cingulo-opercular Alertness Network
Cholinergic Functions and Modulation of the Cingulo-opercular Alertness Network in LBD
Source: ClinicalTrials.gov · Last updated 22 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 23 Mar 2021
- Start date
- 3 May 2021
- Primary completion date
- 26 Aug 2024
- Lead sponsor
- University of Michigan
- Diseases
- Lewy body dementia, Alzheimer disease
- NCT number
- NCT04817891
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 3 May 2021 to the primary completion date, 26 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of anti-cholinergic or neuroleptic drugs
- Previous major radiation exposure
Other illness
- Evidence of large vessel stroke or mass lesion on MRI
- Major psychiatric illness, such as bipolar disorder
- Neurological conditions such as epilepsy, stroke, multiple sclerosis, or moderate to severe brain injury
- A significant history of recent alcohol or drug dependence
Other
- Subjects with contra-indications to MR imaging and/or tDCS, including pacemakers or claustrophobia
- Evidence of atypical parkinsonism on neurological exam
- Sensory impairments that significantly limit one's ability to see or hear
- Pregnancy
Who the study is looking for
- LBD patients (DLB or PDD) who have cognitive fluctuations and who are on stable doses of cholinesterase inhibitors (i.e., at least 4 weeks) will be recruited to participate in this study.
- DLB patients will meet the Fourth consensus report of the DLB Consortium inclusion criteria for probable DLB.
- Subjects will be identified according to the following recognized DLB features: spontaneous parkinsonian motor signs, fluctuating attention and concentration, recurrent well-formed visual hallucinations, presence of REM behavioral sleep disturbance, anosmia/hyposmia,or autonomic dysfunction.
- PDD patients will meet the criteria by Emre et al. (Cognitive deficits in at least two of four of the following cognitive domains: Impaired attention, impaired executive functions, impairment in visuo-spatial functions, impaired free recall memory typically improved with cuing. Must also meet criteria for at least one behavioral symptom: apathy, depressed or anxious mood, hallucinations, delusions, excessive daytime sleepiness). Lack of behavioral symptoms does not exclude the diagnosis. Must also have none of Group III features present: (1) Co-existence of any other abnormality which might cause impairment, but judged not to be the cause of dementia. (2) Time interval between development of motor and cognitive symptoms not known. Must also have none of Group IV symptoms present: (1) Cognitive and behavioral symptoms appear solely in the context of other conditions such as acute confusion caused by systemic diseases or abnormalities, drug intoxication, or major depression according to DSM IV. (2) Features compatible with Probable Vascular Dementia criteria accordingly to NINDS-AIREN.
Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 4250 Plymouth Road (University of Michigan) Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.