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

NCT05971459 | Recruiting

• 1 other identifier: 10013143
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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:

1. 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. 2.To examine how music measures contribute to cognitive and motor performance.
3. 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.

Conditions

Parkinson Disease

Keywords

music therapy

Outcome Measures

Primary Outcomes (1)

• Musical Interface Digital Instruments music measures

  Subtle variations in how participants play music: note frequency

  30 minutes (same session) Note frequency + velocity = musical engagemnet measure

Secondary Outcomes (1)

• Musical Interface Digital Instruments music measures

  30 minutes (same session) Velocity + note frequency = musical engagemnet measure

Other Outcomes (1)

• Debriefing

  15 minutes

Study Arms (2)

Individuals with PD

EXPERIMENTAL

One music therapy session of 30 minutes

Behavioral: Improvised Active Music Therapy

Healthy Individuals

ACTIVE COMPARATOR

One music therapy session of 30 minutes

Behavioral: Improvised Active Music Therapy

Interventions

Improvised Active Music Therapy BEHAVIORAL

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.

Healthy Individuals; Individuals with PD

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wilfrid Laurier University: lead

Study Sites (1)

Wilfrid Laurier University

Waterloo, Ontario, N2L 3C5, Canada

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Demian Kogutek, PhD

CONTACT

+1 548-889-3623; dkogutek@wlu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Mixed-method group comparative study, individuals with PD vs healthy individuals

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 2, 2023
• Study Start: January 15, 2024
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)