xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05971459</url>
    </required_header>
    <id_info>
      <org_study_id>10013143</org_study_id>
      <nct_id>NCT05971459</nct_id>
    </id_info>
    <brief_title>A Study of the Efficacy of IAMT as an Assessment Tool for Prediction of Progression of Parkinson's Disease</brief_title>
    <acronym>Music Therapy</acronym>
    <official_title>A Study of the Efficacy of IAMT as an Assessment Tool for Prediction of Progression of Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wilfrid Laurier University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wilfrid Laurier University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective of this proposal is to examine the efficacy of Improvised Active Music&#xD;
        Therapy (IAMT) sessions as an early novel tool for cognitive and motor assessment for&#xD;
        individuals with Parkinson's Disease (PD) in neurological rehabilitation. This will be&#xD;
        achieved by identifying subtle variations in how participants play music and correlating&#xD;
        these data with mobility and cognitive parameters. The secondary objective is to examine and&#xD;
        understand the participants' experience of playing improvised music through post-session&#xD;
        interviews as a qualitative measure. We propose to conduct a mixed-method, single-blinded,&#xD;
        age-matched group comparison of 25 older adults (= 50 years) with PD and 25 healthy older&#xD;
        adults (= 50 years) at the Conrad Institute for Music Therapy Research (CIMTR), Faculty of&#xD;
        Music, Wilfrid Laurier University. The CIMTR laboratory contains Musical Instrument Digital&#xD;
        Interface (MIDI) equipment/instruments and MATLAB software, which will be used to collect and&#xD;
        analyze the music data to compare the two groups. The long-term goal is to build a database&#xD;
        of sessions to use Improvised Active Music Therapy (IAMT) as a complementary, reliable, and&#xD;
        feasible assessment tool to predict whether older adults with PD will progress to Parkinson's&#xD;
        Disease Dementia (PDD) or Dementia with Lewy Bodies (DLB) and distinguish the motor phenotype&#xD;
        as Tremor Dominant (PDTD), Mixed (PDM), or Postural Instability and Gait Disturbances (PIGD).&#xD;
  &#xD;
        The purpose of this project is to understand the effect of music therapy sessions on&#xD;
        cognition and motor skills within the reciprocal improvised music interactions between music&#xD;
        therapist and clients. Therefore, the specific objectives are as follows:&#xD;
  &#xD;
          1. To examine how physical characteristics of different neurological conditions influence&#xD;
             music measures (note frequency, velocity of movement, synchronization, and acquisition&#xD;
             of rhythmic complexity).&#xD;
  &#xD;
          2. To examine how music measures contribute to cognitive and motor performance.&#xD;
  &#xD;
          3. To assess the contributions of individual difference factors such as diagnoses, hand&#xD;
             dominance, musical training, music preference, participant's personal experience, and&#xD;
             cognitive abilities to music involvement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All participants will be scheduled to come to the testing rooms at the Manfred and Penny&#xD;
        Conrad Institute for Music Therapy Research (CIMTR) Improvisation Laboratory for&#xD;
        participation. After the study is explained, questions are answered, and informed consent is&#xD;
        obtained, the individual will complete the experiment.&#xD;
  &#xD;
        At the beginning of the study, participants will receive a standardized functional and&#xD;
        cognitive evaluation, as well as gait, fine motor, and gross motor assessments at the CIMTR&#xD;
        lab. Additionally, a detailed demographic history will be taken, and prescription and&#xD;
        over-the-counter medications will be recorded. Functional status will be measured using the&#xD;
        Short Physical Performance Battery and the Timed Up &amp; Go Test (TUG) for basic and&#xD;
        instrumental activities of daily living. Global cognition will be assessed using the Mini&#xD;
        Mental State Examination (MMSE), the Montreal Cognitive Assessment (MoCA), the Trail-Making&#xD;
        Test (TMT) A &amp; B, the WAIS-R Digit Symbol Substitution Test (DSST), the Digit Span Test, and&#xD;
        the Letter Number Sequencing test. Fine and gross motor skills will be assessed using the&#xD;
        Action Research Arm Test, the Hydraulic Hand Dynamometer Test, the Box and Block Test (BBT),&#xD;
        and the 9-Hole Pegboard Test (9HPT).&#xD;
  &#xD;
        Following the standardized functional and cognitive evaluation, gait, and fine and gross&#xD;
        motor assessments, participants will undergo one individual IAMT assessment session&#xD;
        consisting of 30 minutes of uninterrupted improvised music at the CIMTR. Participants will&#xD;
        play music on a simplified electronic drum set (Roland TD-11K V-Compact Kit) with two drum&#xD;
        pedals, two drum pads, and two cymbals. The supervised student or accredited music therapist&#xD;
        will facilitate the session with an electric piano (Korg 88-Key) or guitar with MIDI outputs.&#xD;
        MIDI files will be recorded with LogicPro (music software) and processed using MATLAB. The&#xD;
        quantitative music outcomes provided by IAMT will allow us to objectively correlate them with&#xD;
        functional and cognitive parameters.&#xD;
  &#xD;
        During the music improvisation process, the supervised student or accredited music therapist&#xD;
        will carefully listen to the participant's initial musical expression, including tempo,&#xD;
        rhythmic structure, dynamics, and beat. The supervised student or accredited music therapist&#xD;
        will then join, reflecting or confirming aspects of the participant's musical expression&#xD;
        using standard music therapy improvisation techniques such as mirroring, matching,&#xD;
        dialoguing, and containing on their electronic instrument. Mirroring involves playing exactly&#xD;
        what the participant is playing. Matching is playing music that fits the participant's style.&#xD;
        Dialogue is the process of free communication through musical play, allowing the therapist to&#xD;
        introduce new musical material. Containing involves creating stable music that supports the&#xD;
        participant's music. The supervised music therapy student or accredited music therapist will&#xD;
        also incorporate call and response techniques and familiar music within the improvised music.&#xD;
        At this stage, the primary goal will be to meet or blend with the participant's music. The&#xD;
        supervised student or accredited music therapist will maintain these clinical improvisation&#xD;
        techniques throughout the sessions. By comparing the participant's and therapist's musical&#xD;
        responses over the sessions, it will be possible to identify note frequency, velocity of&#xD;
        movement, synchronization, and acquisition of rhythmic complexity.&#xD;
  &#xD;
        Following the music therapy session, the supervised student or accredited music therapist&#xD;
        will conduct a post-session debrief of approximately 15 minutes. This will involve open-ended&#xD;
        and closed-ended questions related to how participants felt during the music therapy session,&#xD;
        their thoughts during the session, and their thoughts about the music played by the&#xD;
        supervised music therapy student or accredited music therapist, as well as their own music&#xD;
        playing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Mixed-method group comparative study, individuals with PD vs healthy individuals</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <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 &amp; 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 &amp; 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).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Musical Interface Digital Instruments music measures</measure>
      <time_frame>30 minutes (same session) Note frequency + velocity = musical engagemnet measure</time_frame>
      <description>Subtle variations in how participants play music: note frequency</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Musical Interface Digital Instruments music measures</measure>
      <time_frame>30 minutes (same session) Velocity + note frequency = musical engagemnet measure</time_frame>
      <description>Subtle variations in how participants play music: velocity of movement</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Debriefing</measure>
      <time_frame>15 minutes</time_frame>
      <description>Post-session interviews as a qualitative measure</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Individuals with PD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>One music therapy session of 30 minutes</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Individuals</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>One music therapy session of 30 minutes</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Improvised Active Music Therapy</intervention_name>
      <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.</description>
      <arm_group_label>Healthy Individuals</arm_group_label>
      <arm_group_label>Individuals with PD</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants must be at least 50 years old, of any gender and location, and have a&#xD;
               clinical diagnosis of Parkinson's Disease (PD).&#xD;
  &#xD;
            -  Participants should be able to understand and communicate in English.&#xD;
  &#xD;
            -  Participants should be capable of walking independently for a distance of 80 meters,&#xD;
               with or without the use of a gait aid (e.g., walker, cane).&#xD;
  &#xD;
            -  Participants should be able to sit independently for 30 minutes at a time.&#xD;
  &#xD;
            -  Participants should be willing to play on a drum-set.&#xD;
  &#xD;
            -  Participants should NOT be deemed cognitively impaired, as indicated by a score of&#xD;
               greater than 24 out of 30 on the Montreal Cognitive Assessment (MOCA).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals who are unable to understand or communicate in English.&#xD;
  &#xD;
            -  Individuals with any other neurological disorder that has residual motor deficits&#xD;
               (e.g., epilepsy, multiple sclerosis).&#xD;
  &#xD;
            -  Individuals who are using psychotropic medications that can affect motor performance&#xD;
               (e.g., neuroleptics/anti-psychotics, anti-convulsants, and benzodiazepines).&#xD;
  &#xD;
            -  Individuals who have experience as a musician or are currently learning to play an&#xD;
               instrument.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Wilfrid Laurier University</investigator_affiliation>
      <investigator_full_name>Demian Kogutek</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>music therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_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.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05971459
  org study id: 10013143
  nct id: NCT05971459
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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:
  
          1. To examine how physical characteristics of different neurological conditions influence
             music measures (note frequency, velocity of movement, synchronization, and acquisition
             of rhythmic complexity).
  
          2. To examine how music measures contribute to cognitive and motor performance.
  
          3. 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.
  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.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Mixed-method group comparative study, individuals with PD vs healthy individuals
  primary purpose: Treatment
  masking: Single (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).
  measure: Musical Interface Digital Instruments music measures
  time frame: 30 minutes (same session) Note frequency + velocity = musical engagemnet measure
  description: Subtle variations in how participants play music: note frequency
  measure: Musical Interface Digital Instruments music measures
  time frame: 30 minutes (same session) Velocity + note frequency = musical engagemnet measure
  description: Subtle variations in how participants play music: velocity of movement
  measure: Debriefing
  time frame: 15 minutes
  description: Post-session interviews as a qualitative measure
  arm group label: Individuals with PD
  arm group type: Experimental
  description: One music therapy session of 30 minutes
  arm group label: Healthy Individuals
  arm group type: Active Comparator
  description: One music therapy session of 30 minutes
  intervention type: Behavioral
  intervention name: Improvised Active Music Therapy
  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.
  arm group label: Healthy Individuals
  arm group label: Individuals with PD
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Wilfrid Laurier University
  investigator full name: Demian Kogutek
  investigator title: Assistant Professor
  mesh term: Parkinson Disease
  sharing ipd: No
  ipd 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.