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Parkinson's Disease (PD)MYSTICNCT07697664

Moving Yourself in Space and Time: MYSTIC

A study testing Complex Rhythmic Movement Sequences (CRMS) Sessions in people with Parkinson's Disease (PD) and Alzheimer's Disease (AD) and Related Disorders, run by Emory University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is being done to answer the question: Do people with Parkinson's benefit from a new stepping therapy, and how do people with Parkinson's best learn new steps and rhythms set to music? Researchers will also compare individuals with Parkinson's Disease with people with Mild Cognitive Impairment, and with… Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
What is being tested?
Complex Rhythmic Movement Sequences (CRMS) Sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteUnited States
Study dates
25 Mar 2022to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 50 to 79 with or without MCI
  • 50 to 79 years old with Parkinson's disease (PD), who do NOT have impaired decision-making capacity
  • Participants who achieve less than 150 minutes moderate or 75 minutes vigorous aerobic activity per week (as per the US Department of Health and Human Services (HHS)),

Who cannot join

  • Acute medical illness requiring hospitalization;
  • Uncontrolled congestive heart failure;
  • History of stroke in the past three years;
  • Inability to perform study procedures;
  • Medical or physical conditions that would preclude participation (e.g., severe arthritis or mobility problems, uncontrolled hypertension or diabetes, renal failure, history of angina with activity);
  • On medications that could adversely affect cognition, e.g., antipsychotics, opioids, stimulants, chemotherapy, and neurologic prescriptions to treat Multiple Sclerosis. When applicable, enrollment will be delayed until dosages are stable on e.g., Aricept, Namenda, anticholinesterase inhibitors, for at least 3 months
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  • Psychotic disorders
  • Confounding neurologic conditions [e.g., active central nervous system (CNS) opportunistic infections, seizure disorders, head injury with loss of consciousness >30 minutes, intracranial neoplasms, stroke with neurological or neuropsychiatric sequelae]
  • Substance Use Disorder, Major Depressive Disorder, and Generalized Anxiety Disorder within six months of evaluation.
  • Inability to provide informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Madeleine E. Hackney, PhD contact

314-412-4852

mehackn@emory.edu

United States1 site, 1 recruiting
  • Emory University, Executive Park, Wesley Woods

    Atlanta, Georgia, 30329

    Madeleine E. Hackney, PhD, mehackn@emory.edu

    Recruiting

Other trials in United States

About this study

Official title: Moving Yourself in Space and Time Identifying Spatial and Temporal Components of Complex Rhythmic Movement Training for People With Parkinson's Disease and Cognitive Impairment

This study is being done to answer the question: Do people with Parkinson's benefit from a new stepping therapy, and how do people with Parkinson's best learn new steps and rhythms set to music? Researchers will also compare individuals with Parkinson's Disease with people with Mild Cognitive Impairment, and with people with neither of these conditions.

The purpose of this study is to identify principles of human-music interactions to establish underlying guiding theories for application to music-based rehabilitation for older populations with neurodegenerative disease, leading to more refined and targeted music-based rhythmic movement therapies.

Read the detailed description

This study aims to analyze the effects of an innovative rehabilitation intervention comprising complex rhythmic movement sequence (CRMS) rehabilitation (aka, Spatiotemporal Activity Modification (STEAM)) training for adults. The central hypothesis is that the spatial and temporal components of CRMS are learned at slower rates in mild cognitive impairment (MCI) than in controls, and that CRMS-based rehabilitation strategies can improve cognitive and mobility status in MCI. Researchers hypothesize that people with cognitive impairment or Parkinson's disease (PD) will show reduced capacity and slower responses when modulating their movements to auditory cues encoded within complex musical-rhythmic patterns.

Musical rhythm, which includes the timing and pattern of sound in music, can be communicated through touch or via audible cues.

Objective 1: Evaluate the hypothesis that people with cognitive impairment or Parkinson's disease (PD) will show reduced capacity and slower responses when modulating their movements to auditory cues encoded within complex musical-rhythmic patterns.

Aim 1. Determine whether the temporal and spatial components of movement are learned at different timescales during human-music movement sequence learning.

Researchers will draw on research in music theory to develop a novel, task-specific set of musical patterns that map and facilitate learning of complex spatiotemporal rhythms during walking tasks. The research team will measure spatial, temporal, and kinematic variables during the physical human-music interaction and will alter combinations of spatial and temporal relationships within movements, in healthy younger (18-35 years), a subset of whom (n=10) are experienced dancers, and individuals (age older than 50 years), individuals with MCI, and individuals with PD. Researchers will analyze data from single-session time courses of learning rhythm, within-session changes, and short-term (24-hour) retention.

Hypothesis: Compared to healthy older adults and younger adults, older adults with MCI and older adults with PD will show (H1a) smaller magnitude and slower learning rates for spatial and temporal movement components, and (H1b) greater challenge with learning-coupled spatio-temporal (more complex) rhythmic movements versus spatial or temporal rhythmic movement components alone. Data from the subset of experienced dancers will help us establish biomechanical markers of expert performance.

Objective 2: Evaluate the preliminary effects, safety, acceptability, and tolerability of rhythmic movement training in healthy younger adults, healthy older adults, older adults with mild cognitive impairment, and older adults with Parkinson's disease.

Aim 2: Explore the thoughts, perceptions, and attitudes of people with MCI and their caregivers, regarding their relationship to music, to dance, and a therapeutic program involving popular music, rhythm, and movement sequences designed for people with MCI.

Aim 2 Approach: Participants with MCI will be interviewed for their thoughts, perceptions, and attitudes regarding CRMS.

Aim 3: Evaluate the feasibility and preliminary effects of a 3-week daily (e.g., 3-5 times per week; 1.5-hour classes) program of varied rhythmic movement sequences performed to music for people with MCI and people with PD.

Researchers will also assess participants before and after the program for clinical, biomechanical, functional, and cognitive measures. Intensive programs have previously been shown to be feasible and effective for similar forms of training and will allow efficient collection of data as well as testing of a useful schedule of treatment.

Being tested
Complex Rhythmic Movement Sequences (CRMS) Sessions
Keywords
Dance, Music, Therapy, Rehabilitation, Neurodegenerative, Parkinson's, Alzheimer's, Motor learning, Motor control
Medical subject headings
Parkinson Disease, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Complex Rhythmic Movement Sequences (CRMS) SessionsOther

    Also called Spatiotemporal activity modification (STEAM)

    Researchers will establish complex rhythmic movement sequences (CRMS) as an experimental paradigm to identify spatial and temporal components and learning time courses of complex rhythmic movement.

    Participants will dance with new partners every 15-20 minutes, a widely practiced method of the dance community to enhance learning. The class format is:

    1. practicing previously learned steps
    2. 25-minute warmup, partnering/rhythmic exercises
    3. learning new steps
    4. combining old and new steps
    5. cool down

    Participants dance both leading and following roles, learn how to interpret motor goals through touch, and perform activities to foster understanding of the temporal relationship of movement to music.

Study groups in NCT07697664
Study groupRoleWhat they receive
Older adults with MCIExperimentalParticipants will attend daily (3-5 times/week) lessons that will last 1.5h for a month (e.g., 3-5 weeks) and will receive contact and monitoring from study staff. The Principal Investigator will monitor fidelity via weekly reports from interventionists.
Receives: Other: Complex Rhythmic Movement Sequences (CRMS) Sessions
Older adults without MCIActive comparatorParticipants will attend daily (3-5 times/week) lessons that will last 1.5h for a month (e.g., 3-5 weeks) and will receive contact and monitoring from study staff. The Principal Investigator will monitor fidelity via weekly reports from interventionists.
Receives: Other: Complex Rhythmic Movement Sequences (CRMS) Sessions
Older adults with PDExperimentalParticipants will attend daily (3-5 times/week) lessons that will last 1.5 h for a month (e.g., 3-5 weeks) and will receive contact and monitoring from study staff. The Principal Investigator will monitor fidelity via weekly reports from interventionists.
Receives: Other: Complex Rhythmic Movement Sequences (CRMS) Sessions
Young adults and adults with normal cognition (NC)Active comparatorParticipants will attend daily (3-5 times/week) lessons that will last 1.5h for a month (e.g., 3-5 weeks) and will receive contact and monitoring from study staff. The Principal Investigator will monitor fidelity via weekly reports from interventionists.
Receives: Other: Complex Rhythmic Movement Sequences (CRMS) Sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Four-Square Step Test (FSST)

    The Four Square Step Test (FSST) assesses mechanisms underlying motor-cognitive integration. FSST requires participants to step clockwise, then counterclockwise, into four squares created by rods arranged on the ground in a cross. Participants are instructed to perform FSST "as quickly and as safely as you can," not to touch the rods, and to make both feet contact the floor in each square. Timing begins when the participant initiates movement and stops when both feet are back in the starting square after completing the sequence. Trials will be repeated if the participant does not understand the instructions, fails to complete the sequence accurately, loses balance, or touches a rod. Three successful trials will be recorded, and the fastest time selected for analysis. Lower scores are better.

    Measured: Baseline and post-intervention (3 to 5 weeks)

  2. Gait Speed

    Gait speed testing (Forward/Backwards/Fast): How quickly a person can walk within a specific distance forward and Backwards using GAITRite. GAITRite is a pressure-sensitive walkway that can assess gait anomalies. Lower scores are better.

    Measured: Baseline and post-intervention (3 to 5 weeks)

  3. Body Position Spatial Task (BPST)

    Body Position Spatial Task (BPST) is a validated visuospatial memory task. The BPST incorporates spatial memory and navigational skills while maintaining posture. The examiner verbally and visually shows a series of side, forward, and turning steps, which the examinee repeats. If the examinee repeats the entire pattern correctly, they are scored as 1; any incorrect parts of the pattern result in a score of 0. Participants complete up to 8 different sequences and have up to 2 tries to perform the sequence correctly. Total scores can range from 0 to 8, with higher values indicating more sequences correctly performed and better.

    Measured: Baseline and post-intervention (3 to 5 weeks)

  4. 30-Second Sit-to-Stand test

    The number of sit-to-stand maneuvers completed in 30 seconds is used to measure leg strength and endurance. A higher score is better.

    Measured: Baseline and post-intervention (3 to 5 weeks)

  5. 360 Turn Test (Steps)

    The number of steps the participant takes to turn around in a complete circle. Lower number of steps is better.

    Measured: Baseline and post-intervention (3 to 5 weeks)

  6. 360 Turn Test (Time)

    The time it takes the participants to turn around in a complete circle. Lower times are better.

    Measured: Baseline and post-intervention (3 to 5 weeks)

Secondary outcomes (3)
  1. Timed Up and Go Simple and Dual tasks (TUG, TUG Cognitive and TUG Manual)

    Measures the time it takes to rise from a chair, walk 3 meters, turn around, and return to the chair in the simple condition. In the Cognitive condition, one is required to simultaneously count backward by 3s from a number between 20 and 100; in the Manual condition, one is required to simultaneously pick up a cup of water and carry it while completing the task. A lower score is a better outcome.

    Measured: Baseline and post-intervention (3 to 5 weeks)

  2. Short Form 12-Quality of Life (SF12)

    The SF12 evaluates the level of activity and perceived physical and mental quality of life.

    The SF-12 uses a standardized system with scores ranging from 0 to 100, where the general population's average is 50, with higher scores indicating better health. Because it measures relative deviation, the numbers represent the following health levels:

    Above 50: Better than average health. Exactly 50: Average health status. 40 to 50: Below average health (mild disability or impairment). 30 to 40: Moderate disability or impairment. Below 40: Severe impairment or disability.

    Measured: Baseline and post-intervention (3 to 5 weeks)

  3. Activities-specific Balance Confidence Scale (ABC)

    The Activities-specific Balance Confidence (ABC) Scale is a 16-item self-report questionnaire used to measure an individual's confidence in performing daily activities without losing their balance or feeling unsteady. Participants rate their self-confidence on a percentage scale from 0% (no confidence) to 100% (completely confident) for 16 specific tasks.

    The total score is added for all 16 items and divided by 16 to get the average percentage score.

    ≥ 80%: Indicates a high level of physical functioning and balance confidence. 50% to 80%: Indicates a moderate level of physical functioning. < 50%: Indicates a low level of physical functioning.

    Higher scores indicate a higher level of functioning and a lower risk of falling, while lower scores (below 67%) often indicate a higher risk of falling.

    Measured: Baseline and post-intervention (3 to 5 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start25 Mar 2022
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07697664
Sponsor's protocol ID
2025P010753
Acronym
MYSTIC
Status last verified
Jul 2026
First submitted
7 Jul 2026
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Complex Rhythmic Movement Sequences (CRMS) Sessions in people with Parkinson's Disease (PD) and Alzheimer's Disease (AD) and Related Disorders, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Madeleine E. Hackney, PhD (314-412-4852, mehackn@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Four-Square Step Test (FSST) (time frame: Baseline and post-intervention (3 to 5 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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