Stimulation of Cingulo-opercular Alertness Network

NCT04817891 | Completed Results DMC FDA Device

• 2 other identifiers: HUM00184296R21AG069387
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lewy Body Dementia; Cognitive; Thinking; Cognition; Cognitive Rehabilitation; Brain Stimulation; Imaging; Lewy Body; Dementia

Outcome Measures

Primary Outcomes (1)

• Dementia Cognitive Fluctuations Scale

  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.

  Baseline and Post-Testing (3-4 weeks)

Secondary Outcomes (3)

• Resting State fMRI

  Baseline and Post-Testing (3-4 weeks)

• Stroop Color Word Interference Test - Cognitive Control Performance

  Baseline, 3-4 weeks

• Objective Measures of Working Memory (N-back Test)

  Baseline, 3-4 weeks

Study Arms (1)

Experimental: HD-tDCS

EXPERIMENTAL

Maximum 4 milliAmp (mA) per channel of HD-tDCS treatment for 20 minutes, for 10 sessions. Total mA dose determined by individualized computational models.

Device: HD-tDCS

Interventions

HD-tDCS DEVICE

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

Experimental: HD-tDCS

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Subjects with contra-indications to MR imaging and/or tDCS, including pacemakers or claustrophobia
• Evidence of large vessel stroke or mass lesion on MRI
• Use of anti-cholinergic or neuroleptic drugs
• Evidence of atypical parkinsonism on neurological exam
• Major psychiatric illness, such as bipolar disorder
• Neurological conditions such as epilepsy, stroke, multiple sclerosis, or moderate to severe brain injury
• Sensory impairments that significantly limit one's ability to see or hear
• A significant history of recent alcohol or drug dependence
• Previous major radiation exposure
• Pregnancy

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

4250 Plymouth Road (University of Michigan)

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Lewy Body Disease; Lewy Body Variant of Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Benjamin Hampstead
• Organization: University of Michigan

bhampste@med.umich.edu

734-936-6185

Study Officials

• Benjamin Hampstead, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigator, Outcomes Assessor, and Participant/Care Provider will all know the participant is receiving intervention/stimulation. There is no placebo condition.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Eligible participants receive individualized intervention/stimulation based on their fMRI and PET imaging.

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: May 3, 2021
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: October 22, 2025
• Results First Posted: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)