Rhythmic Entrainment and Alertness in Lewy Body Dementia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Rhythmic Auditory Cueing
BehavioralParticipants 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Auditory-Cued Finger TappingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 1, during each of six 2-minute auditory-cued finger-tapping trials2
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.
Time frame
Day 1, during each of six 2-minute auditory-cued finger-tapping trialsSecondary outcomes
1
EEG Alertness Index as assessed by theta/alpha ratio (TAR)
The EEG Alertness Index will be calculated as the frontal theta/posterior alpha ratio (TAR) from eyes-open resting-state EEG recordings collected between finger-tapping blocks. TAR is an EEG marker of cortical arousal, with higher TAR indicating lower alertness. TAR will be examined in relation to neural and behavioral rhythmic entrainment across auditory cueing conditions. Collected at a single study visit; during 2-minute eyes-open resting-state EEG recordings collected between tapping blocks
Time frame
Day 1, during each 2-minute eyes-open resting-state EEG recording collected between finger-tapping blocks2
Participant-reported alertness as assessed by Visual Analogue Scale (VAS)
Participants will provide repeated Visual Analogue Scale ratings of their momentary alertness between finger-tapping blocks. These ratings will be used to characterize within-session variation in alertness and examine its relationship with neural and behavioral measures of rhythmic entrainment. Scale 1-10 lower score better. Collected at a single study visit; assessed between tapping blocks.
Time frame
Day 1, immediately after each of six 2-minute auditory-cued finger-tapping trials3
Care-partner-reported participant alertness as assessed by Visual Analogue Scale (VAS)
Care partners will provide repeated Visual Analogue Scale ratings of the participant's momentary alertness between finger-tapping blocks. These ratings will provide an additional measure of within-session alertness variation and will be examined in relation to neural and behavioral measures of rhythmic entrainment. Scale 1-10 lower score better. Collected at a single study visit; assessed between tapping blocks.
Time frame
Day 1, immediately after each of six 2-minute auditory-cued finger-tapping trialsLocations
Sponsors and contacts
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Johns Hopkins University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov
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