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A Study of the Efficacy of IAMT as an Assessment Tool for Prediction of Progression of Parkinson's Disease (Music Therapy)

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Improvised Active Music Therapy
Sponsored by
Wilfrid Laurier University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring music therapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participants must be at least 50 years old, of any gender and location, and have a clinical diagnosis of Parkinson's Disease (PD). Participants should be able to understand and communicate in English. Participants should be capable of walking independently for a distance of 80 meters, with or without the use of a gait aid (e.g., walker, cane). Participants should be able to sit independently for 30 minutes at a time. Participants should be willing to play on a drum-set. Participants should NOT be deemed cognitively impaired, as indicated by a score of greater than 24 out of 30 on the Montreal Cognitive Assessment (MOCA). Exclusion Criteria: Individuals who are unable to understand or communicate in English. Individuals with any other neurological disorder that has residual motor deficits (e.g., epilepsy, multiple sclerosis). Individuals who are using psychotropic medications that can affect motor performance (e.g., neuroleptics/anti-psychotics, anti-convulsants, and benzodiazepines). Individuals who have experience as a musician or are currently learning to play an instrument.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Individuals with PD

    Healthy Individuals

    Arm Description

    One music therapy session of 30 minutes

    One music therapy session of 30 minutes

    Outcomes

    Primary Outcome Measures

    Musical Interface Digital Instruments music measures
    Subtle variations in how participants play music: note frequency

    Secondary Outcome Measures

    Musical Interface Digital Instruments music measures
    Subtle variations in how participants play music: velocity of movement

    Full Information

    First Posted
    July 11, 2023
    Last Updated
    July 24, 2023
    Sponsor
    Wilfrid Laurier University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05971459
    Brief Title
    A Study of the Efficacy of IAMT as an Assessment Tool for Prediction of Progression of Parkinson's Disease
    Acronym
    Music Therapy
    Official Title
    A Study of the Efficacy of IAMT as an Assessment Tool for Prediction of Progression of Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    August 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wilfrid Laurier University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective of this proposal is to examine the efficacy of Improvised Active Music Therapy (IAMT) sessions as an early novel tool for cognitive and motor assessment for individuals with Parkinson's Disease (PD) in neurological rehabilitation. This will be achieved by identifying subtle variations in how participants play music and correlating these data with mobility and cognitive parameters. The secondary objective is to examine and understand the participants' experience of playing improvised music through post-session interviews as a qualitative measure. We propose to conduct a mixed-method, single-blinded, age-matched group comparison of 25 older adults (= 50 years) with PD and 25 healthy older adults (= 50 years) at the Conrad Institute for Music Therapy Research (CIMTR), Faculty of Music, Wilfrid Laurier University. The CIMTR laboratory contains Musical Instrument Digital Interface (MIDI) equipment/instruments and MATLAB software, which will be used to collect and analyze the music data to compare the two groups. The long-term goal is to build a database of sessions to use Improvised Active Music Therapy (IAMT) as a complementary, reliable, and feasible assessment tool to predict whether older adults with PD will progress to Parkinson's Disease Dementia (PDD) or Dementia with Lewy Bodies (DLB) and distinguish the motor phenotype as Tremor Dominant (PDTD), Mixed (PDM), or Postural Instability and Gait Disturbances (PIGD). The purpose of this project is to understand the effect of music therapy sessions on cognition and motor skills within the reciprocal improvised music interactions between music therapist and clients. Therefore, the specific objectives are as follows: To examine how physical characteristics of different neurological conditions influence music measures (note frequency, velocity of movement, synchronization, and acquisition of rhythmic complexity). To examine how music measures contribute to cognitive and motor performance. To assess the contributions of individual difference factors such as diagnoses, hand dominance, musical training, music preference, participant's personal experience, and cognitive abilities to music involvement.
    Detailed Description
    All participants will be scheduled to come to the testing rooms at the Manfred and Penny Conrad Institute for Music Therapy Research (CIMTR) Improvisation Laboratory for participation. After the study is explained, questions are answered, and informed consent is obtained, the individual will complete the experiment. At the beginning of the study, participants will receive a standardized functional and cognitive evaluation, as well as gait, fine motor, and gross motor assessments at the CIMTR lab. Additionally, a detailed demographic history will be taken, and prescription and over-the-counter medications will be recorded. Functional status will be measured using the Short Physical Performance Battery and the Timed Up & Go Test (TUG) for basic and instrumental activities of daily living. Global cognition will be assessed using the Mini Mental State Examination (MMSE), the Montreal Cognitive Assessment (MoCA), the Trail-Making Test (TMT) A & B, the WAIS-R Digit Symbol Substitution Test (DSST), the Digit Span Test, and the Letter Number Sequencing test. Fine and gross motor skills will be assessed using the Action Research Arm Test, the Hydraulic Hand Dynamometer Test, the Box and Block Test (BBT), and the 9-Hole Pegboard Test (9HPT). Following the standardized functional and cognitive evaluation, gait, and fine and gross motor assessments, participants will undergo one individual IAMT assessment session consisting of 30 minutes of uninterrupted improvised music at the CIMTR. Participants will play music on a simplified electronic drum set (Roland TD-11K V-Compact Kit) with two drum pedals, two drum pads, and two cymbals. The supervised student or accredited music therapist will facilitate the session with an electric piano (Korg 88-Key) or guitar with MIDI outputs. MIDI files will be recorded with LogicPro (music software) and processed using MATLAB. The quantitative music outcomes provided by IAMT will allow us to objectively correlate them with functional and cognitive parameters. During the music improvisation process, the supervised student or accredited music therapist will carefully listen to the participant's initial musical expression, including tempo, rhythmic structure, dynamics, and beat. The supervised student or accredited music therapist will then join, reflecting or confirming aspects of the participant's musical expression using standard music therapy improvisation techniques such as mirroring, matching, dialoguing, and containing on their electronic instrument. Mirroring involves playing exactly what the participant is playing. Matching is playing music that fits the participant's style. Dialogue is the process of free communication through musical play, allowing the therapist to introduce new musical material. Containing involves creating stable music that supports the participant's music. The supervised music therapy student or accredited music therapist will also incorporate call and response techniques and familiar music within the improvised music. At this stage, the primary goal will be to meet or blend with the participant's music. The supervised student or accredited music therapist will maintain these clinical improvisation techniques throughout the sessions. By comparing the participant's and therapist's musical responses over the sessions, it will be possible to identify note frequency, velocity of movement, synchronization, and acquisition of rhythmic complexity. Following the music therapy session, the supervised student or accredited music therapist will conduct a post-session debrief of approximately 15 minutes. This will involve open-ended and closed-ended questions related to how participants felt during the music therapy session, their thoughts during the session, and their thoughts about the music played by the supervised music therapy student or accredited music therapist, as well as their own music playing.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    music therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Mixed-method group comparative study, individuals with PD vs healthy individuals
    Masking
    Participant
    Masking Description
    Participants will receive a standardized functional and cognitive evaluation, as well as gait, fine motor, and gross motor assessments. Functional status will be measured using the Short Physical Performance Battery and the Timed Up & Go Test (TUG) for basic and instrumental activities of daily living. Global cognition will be assessed using the Mini Mental State Examination (MMSE), the Montreal Cognitive Assessment (MoCA), the Trail-Making Test (TMT) A & B, the WAIS-R Digit Symbol Substitution Test (DSST), the Digit Span Test, and the Letter Number Sequencing test. Fine and gross motor skills will be assessed using the Action Research Arm Test, the Hydraulic Hand Dynamometer Test, the Box and Block Test (BBT), and the 9-Hole Pegboard Test (9HPT).
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Individuals with PD
    Arm Type
    Experimental
    Arm Description
    One music therapy session of 30 minutes
    Arm Title
    Healthy Individuals
    Arm Type
    Active Comparator
    Arm Description
    One music therapy session of 30 minutes
    Intervention Type
    Behavioral
    Intervention Name(s)
    Improvised Active Music Therapy
    Intervention Description
    During the music improvisation process, the accredited music therapist will carefully listen to the participant's initial musical expression, including tempo, rhythmic structure, dynamics, and beat. The accredited music therapist will then join, reflecting or confirming aspects of the participant's musical expression using standard music therapy improvisation techniques such as mirroring, matching, dialoguing, and containing on their electronic instrument. By comparing the participant's and therapist's musical responses over the sessions, it will be possible to identify note frequency, velocity of movement, synchronization, and acquisition of rhythmic complexity.
    Primary Outcome Measure Information:
    Title
    Musical Interface Digital Instruments music measures
    Description
    Subtle variations in how participants play music: note frequency
    Time Frame
    30 minutes (same session) Note frequency + velocity = musical engagemnet measure
    Secondary Outcome Measure Information:
    Title
    Musical Interface Digital Instruments music measures
    Description
    Subtle variations in how participants play music: velocity of movement
    Time Frame
    30 minutes (same session) Velocity + note frequency = musical engagemnet measure
    Other Pre-specified Outcome Measures:
    Title
    Debriefing
    Description
    Post-session interviews as a qualitative measure
    Time Frame
    15 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants must be at least 50 years old, of any gender and location, and have a clinical diagnosis of Parkinson's Disease (PD). Participants should be able to understand and communicate in English. Participants should be capable of walking independently for a distance of 80 meters, with or without the use of a gait aid (e.g., walker, cane). Participants should be able to sit independently for 30 minutes at a time. Participants should be willing to play on a drum-set. Participants should NOT be deemed cognitively impaired, as indicated by a score of greater than 24 out of 30 on the Montreal Cognitive Assessment (MOCA). Exclusion Criteria: Individuals who are unable to understand or communicate in English. Individuals with any other neurological disorder that has residual motor deficits (e.g., epilepsy, multiple sclerosis). Individuals who are using psychotropic medications that can affect motor performance (e.g., neuroleptics/anti-psychotics, anti-convulsants, and benzodiazepines). Individuals who have experience as a musician or are currently learning to play an instrument.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    All data collected in the study will be retained for a period of 10 years after the completion of the study. After this time, the study data will be disposed of following the confidential shredding and recycling system implemented at Wilfrid Laurier University for the destruction of medical records.

    Learn more about this trial

    A Study of the Efficacy of IAMT as an Assessment Tool for Prediction of Progression of Parkinson's Disease

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