Rhythmic Entrainment and Alertness in Lewy Body Dementia

NCT07846189 | Not Yet Recruiting

• 2 other identifiers: IRB00582709U24AG084436
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will examine how people with dementia with Lewy bodies (DLB) or mild cognitive impairment with Lewy bodies respond to rhythmic auditory cues, and whether changes in alertness affect ability to synchronize movements to a rhythm. Participants will complete a single study visit that includes finger-tapping tasks performed with and without rhythmic auditory cues at different tempos. Brain activity will be recorded using electroencephalography (EEG), and tapping performance will be measured. Participants and the participant's study partners will also provide repeated ratings of alertness during the visit. The study aims to identify brain and behavioral measures of rhythmic synchronization and determine whether these measures change depending on a participant's level of alertness. The findings will help guide the development of future rhythm-based interventions for people with DLB.

Conditions

Lewy Body Dementia (LBD); Dementia With Lewy Bodies (DLB)

Keywords

rhythmic auditory stimulation; rhythmic entrainment; auditory-motor synchronization; electroencephalography (EEG); alertness; cognitive fluctuations

Outcome Measures

Primary Outcomes (2)

• Beta-band event-related desynchronization (β-ERD) during auditory-cued finger tapping

  Beta-band event-related desynchronization (β-ERD; 13-30 Hz) will be derived from task-related EEG recorded during auditory-cued finger tapping. β-ERD is an EEG measure of sensorimotor activation and auditory-motor coupling during rhythmic movement. β-ERD will be compared across the three auditory cueing tempo conditions: preferred tempo, 20% slower than preferred tempo, and 20% faster than preferred tempo. Collected at a single study visit; during six 2-minute auditory-cued finger-tapping trials.

  Day 1, during each of six 2-minute auditory-cued finger-tapping trials

• Inter-tap interval coefficient of variation (ITI-CV) during auditory-cued finger tapping

  Inter-tap interval coefficient of variation (ITI-CV) will be calculated from the timing of consecutive finger taps during auditory-cued finger tapping. ITI-CV measures variability in tapping intervals and serves as an index of motor-timing precision and rhythmic consistency, with lower values indicating more consistent tapping. ITI-CV will be compared across the three auditory cueing tempo conditions: preferred tempo, 20% slower than preferred tempo, and 20% faster than preferred tempo. Collected at a single study visit; during six 2-minute auditory-cued finger-tapping trials.

  Day 1, during each of six 2-minute auditory-cued finger-tapping trials

Secondary Outcomes (3)

• EEG Alertness Index as assessed by theta/alpha ratio (TAR)

  Day 1, during each 2-minute eyes-open resting-state EEG recording collected between finger-tapping blocks

• Participant-reported alertness as assessed by Visual Analogue Scale (VAS)

  Day 1, immediately after each of six 2-minute auditory-cued finger-tapping trials

• Care-partner-reported participant alertness as assessed by Visual Analogue Scale (VAS)

  Day 1, immediately after each of six 2-minute auditory-cued finger-tapping trials

Study Arms (1)

Auditory-Cued Finger Tapping

EXPERIMENTAL

Participants will complete a single-session finger-tapping protocol. After a 1-minute self-paced tapping trial to determine preferred tempo, participants will complete six 2-minute auditory-cued tapping trials at three tempo conditions: preferred tempo, 20% slower, and 20% faster, with each condition repeated twice in randomized order. EEG and tapping responses will be recorded during the task, and alertness will be assessed between tapping blocks.

Behavioral: Rhythmic Auditory Cueing

Interventions

Rhythmic Auditory Cueing BEHAVIORAL

Participants will perform finger-tapping tasks while listening to rhythmic auditory cues presented at three tempo conditions: preferred tempo, 20% slower, and 20% faster. Each cued condition will be repeated twice in randomized order.

Auditory-Cued Finger Tapping

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Diagnosis of probable dementia with Lewy bodies (DLB) or mild cognitive impairment with Lewy bodies (MCI-LB) based on established clinical diagnostic criteria
• Fluent in English
• Able to attend with a study partner who can complete care-partner-reported cognitive fluctuation measures
• Clinical Dementia Rating (CDR) global score of 0.5-1.0
• Adequate upper-limb motor function, defined as Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III finger-tapping item (3.4) score ≤2 on at least one hand and ability to sustain rhythmic tapping for at least 10 seconds at approximately 1-3 Hz during a brief practice trial
• Adequate hearing, corrected if necessary, to perceive rhythmic auditory cues
• Stable on all medications for at least 30 days before enrollment

You may not qualify if:

• Age younger than 18 years
• CDR global score ≥2.0
• Severe upper-limb impairment, defined as MDS-UPDRS Part III finger-tapping item (3.4) score ≥3 in the dominant hand, or inability to produce more than 10 consecutive taps at ≥1 Hz despite instruction/practice
• Other neurological, musculoskeletal, or sensory conditions that preclude safe or reliable task participation

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Related Publications (8)

• Baik K, Jung JH, Jeong SH, Chung SJ, Yoo HS, Lee PH, Sohn YH, Kang SW, Ye BS. Implication of EEG theta/alpha and theta/beta ratio in Alzheimer's and Lewy body disease. Sci Rep. 2022 Nov 4;12(1):18706. doi: 10.1038/s41598-022-21951-5.

  PMID: 36333386 BACKGROUND

• Pantelyat A, Dayanim G, Kang K, Turk B, Pagkatipunan R, Huenergard SK, Mears A, Bang J. Rhythmic auditory cueing in atypical parkinsonism: A pilot study. Front Neurol. 2022 Oct 28;13:1018206. doi: 10.3389/fneur.2022.1018206. eCollection 2022.

  PMID: 36388209 BACKGROUND

• Stylianou M, Murphy N, Peraza LR, Graziadio S, Cromarty R, Killen A, O' Brien JT, Thomas AJ, LeBeau FEN, Taylor JP. Quantitative electroencephalography as a marker of cognitive fluctuations in dementia with Lewy bodies and an aid to differential diagnosis. Clin Neurophysiol. 2018 Jun;129(6):1209-1220. doi: 10.1016/j.clinph.2018.03.013. Epub 2018 Apr 3.

  PMID: 29656189 BACKGROUND

• Donaghy PC, Carrarini C, Ferreira D, Habich A, Aarsland D, Babiloni C, Bayram E, Kane JP, Lewis SJ, Pilotto A, Thomas AJ, Bonanni L; Alzheimer's Association International Society to Advance Alzheimer's Research and Treatment Lewy Body Dementias Prodromal Working Group. Research diagnostic criteria for mild cognitive impairment with Lewy bodies: A systematic review and meta-analysis. Alzheimers Dement. 2023 Jul;19(7):3186-3202. doi: 10.1002/alz.13105. Epub 2023 Apr 24.

  PMID: 37096339 BACKGROUND

• McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7.

  PMID: 28592453 BACKGROUND

• D'Antonio F, Kane JPM, Ibanez A, Lewis SJG, Camicioli R, Wang H, Yu Y, Zhang J, Ji Y, Borda MG, Kandadai RM, Babiloni C, Bonanni L, Ikeda M, Boeve BF, Leverenz JB, Aarsland D; ISTAART Lewy body dementias Consortia Working Group. Dementia with Lewy bodies research consortia: A global perspective from the ISTAART Lewy Body Dementias Professional Interest Area working group. Alzheimers Dement (Amst). 2021 Sep 14;13(1):e12235. doi: 10.1002/dad2.12235. eCollection 2021.

  PMID: 34541289 BACKGROUND

• Rahimi J, Kovacs GG. Prevalence of mixed pathologies in the aging brain. Alzheimers Res Ther. 2014 Nov 21;6(9):82. doi: 10.1186/s13195-014-0082-1. eCollection 2014.

  PMID: 25419243 BACKGROUND

• Mueller C, Ballard C, Corbett A, Aarsland D. The prognosis of dementia with Lewy bodies. Lancet Neurol. 2017 May;16(5):390-398. doi: 10.1016/S1474-4422(17)30074-1. Epub 2017 Mar 22.

  PMID: 28342649 BACKGROUND

MeSH Terms

Conditions

Lewy Body Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Kyurim Kang, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyurim Kang, PhD

CONTACT

410-614-5671; kkang19@jhmi.edu

Alexander Pantelyat, MD

CONTACT

4105023290; apantel1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: tempo conditions are presented in randomized order, and participants are not informed of the specific tempo labels
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants complete the same single-session, within-subject protocol. Following a self-paced finger-tapping trial, participants complete six auditory-cued tapping trials across three tempo conditions (preferred tempo, 20% slower, and 20% faster), with each condition repeated twice in randomized order.

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share