An interventional study of Rhythmic Auditory Cueing in Dementia With Lewy Bodies (DLB) and Lewy Body Dementia (LBD), sponsored by Johns Hopkins University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Basic science
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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.
REACT-DLB is a single-session, within-participant mechanistic study designed to characterize neural and behavioral responses to rhythmic auditory cueing in individuals with probable dementia with Lewy bodies (DLB) or mild cognitive impairment with Lewy bodies. The target enrollment is 30 participants with a Clinical Dementia Rating (CDR) global score of 0.5-1.0, with balanced recruitment across CDR 0.5 and 1.0 when feasible.
Participants will first complete a self-paced finger-tapping trial to determine the participant's preferred tapping tempo. Participants will then complete six auditory-cued tapping trials at three tempo conditions: preferred tempo, 20% slower than preferred tempo, and 20% faster than preferred tempo. The tempo conditions will be presented in randomized order. EEG and finger-tapping responses will be recorded during the task.
The primary neural measure of rhythmic entrainment is beta-band event-related desynchronization (β-ERD), and the primary behavioral measure is inter-tap-interval coefficient of variation (ITI-CV). Exploratory measures include delta/theta inter-trial phase coherence (ITPC), mean asynchrony between taps and auditory cues, and continuation drift.
To evaluate whether momentary alertness influences rhythmic entrainment, participants and care partners will provide repeated Visual Analogue Scale ratings of alertness between tapping blocks, and brief eyes-open resting-state EEG recordings will be collected. The EEG theta/alpha ratio will be used as a neural index of alertness. Clinician- and care-partner-reported measures of cognitive fluctuation will also be collected. Analyses will examine whether alertness measures are associated with differences in neural and behavioral rhythmic entrainment.
For participants taking levodopa, study testing will be scheduled during the participant's best clinically defined ON state when applicable. If a clear best ON state cannot be identified, testing will occur within approximately one hour of medication administration. Participants not taking levodopa will be tested in the participant's usual clinically stable medication state.
The active finger-tapping component lasts approximately 13 minutes. Including rest periods and alertness assessments, the tapping-related portion is expected to take approximately 20-25 minutes. The entire study visit, including consent, questionnaires, EEG setup and recording, tapping tasks, and breaks, is expected to last approximately 90-120 minutes.
239 studies on the registry are indexed under Lewy Body Disease; 88 are open to participants now.
This study's planned enrollment of 30 is below the median of 89 across 152 interventional studies indexed under Lewy Body Disease.
Browse Lewy Body Disease studies →Johns Hopkins University is the lead sponsor of 1,816 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Exclusion Criteria:
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
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.
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 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.
Time frame: Day 1, during each of six 2-minute auditory-cued finger-tapping trials
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 blocks
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 trials
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 trials
No study locations are listed for this record.
Plan to share: No
Start is estimated for Nov 2026; primary completion for Jul 2027, 8 months later.
Of 59 non-industry interventional studies with no phase under Lewy Body Disease, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 53. This study's planned 8 months is below that.
Counting every sponsor, half of 63 studies reached it within 35 months; a quarter within 26 and three quarters within 61.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 9, 2026: start Oct 2026 → Nov 2026, primary completion Oct 2027 → Jul 2027 and completion Dec 2027 → Jul 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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