Parkinson DiseaseMusic TherapyNCT05971459
A Study of the Efficacy of IAMT as an Assessment Tool for Prediction of Progression of Parkinson's Disease
A study testing Improvised Active Music Therapy in people with Parkinson Disease, run by Wilfrid Laurier University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Improvised Active Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Wilfrid Laurier University
Waterloo, Ontario, N2L 3C5
Demian Kogutek, PhD, +1 548-889-3623, dkogutek@wlu.ca
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Improvised Active Music Therapy
- Keywords
- music therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improvised Active Music TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with PD | Experimental | One music therapy session of 30 minutes Receives: Behavioral: Improvised Active Music Therapy |
| Healthy Individuals | Active comparator | One music therapy session of 30 minutes Receives: Behavioral: Improvised Active Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musical Interface Digital Instruments music measures
Subtle variations in how participants play music: note frequency
Measured: 30 minutes (same session) Note frequency + velocity = musical engagemnet measure
Secondary outcomes (1)
Musical Interface Digital Instruments music measures
Subtle variations in how participants play music: velocity of movement
Measured: 30 minutes (same session) Velocity + note frequency = musical engagemnet measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start15 Jan 2024
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Mixed-method group comparative study, individuals with PD vs healthy individuals
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wilfrid Laurier University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demian Kogutek, Wilfrid Laurier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971459
- Sponsor's protocol ID
- 10013143
- Acronym
- Music Therapy
- Status last verified
- May 2024
- First submitted
- 11 Jul 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy of IAMT as an Assessment Tool for Prediction of Progression of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05971459
- Acronym / sponsor ID
- Music Therapy / 10013143
- Conditions
- Parkinson Disease
- Keywords
- music therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wilfrid Laurier UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Mixed-method group comparative study, individuals with PD vs healthy individuals
| Arm | Type | Receives |
|---|---|---|
| Individuals with PD | Experimental | Behavioral: Improvised Active Music TherapyOne music therapy session of 30 minutes |
| Healthy Individuals | Active comparator | Behavioral: Improvised Active Music TherapyOne music therapy session of 30 minutes |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improvised Active Music TherapyDuring 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. | Behavioural | Healthy Individuals, Individuals with PD |
Primary outcome
Musical Interface Digital Instruments music measures
Time frame: 30 minutes (same session) Note frequency + velocity = musical engagemnet measure
Subtle variations in how participants play music: note frequency
1 secondary outcome
Musical Interface Digital Instruments music measures
Time frame: 30 minutes (same session) Velocity + note frequency = musical engagemnet measure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improvised Active Music Therapy in people with Parkinson Disease, run by Wilfrid Laurier University at 1 site in Canada.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 May 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Demian Kogutek, PhD (+1 548-889-3623, dkogutek@wlu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musical Interface Digital Instruments music measures (time frame: 30 minutes (same session) Note frequency + velocity = musical engagemnet measure). 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 9 May 2024.