Rhythmic Entrainment and Alertness Co-modulating Test in Dementia With Lewy Bodies (REACT-DLB): Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Beta-band event-related desynchronization (β-ERD) during auditory-cued finger tapping
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
tempo conditions are presented in randomized order, and participants are not informed of the specific tempo labels
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Auditory-Cued Finger Tapping
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.
干预措施: Rhythmic Auditory Cueing (Behavioral)
结局指标
主要结局
Beta-band event-related desynchronization (β-ERD) during auditory-cued finger tapping
时间窗: Day 1, during each of six 2-minute auditory-cued finger-tapping trials
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.
Inter-tap interval coefficient of variation (ITI-CV) during auditory-cued finger tapping
时间窗: Day 1, during each of six 2-minute auditory-cued finger-tapping trials
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.
次要结局
- 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)