fNIRS Studies of Music Intervention of Parkinson's Disease

NCT04212897 | Unknown

• 1 other identifier: PJ-KY-2019-123
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Functional near-infrared spectroscopy (fNIRS) will be used to monitor neuronal activities and connectivity to elucidate the correlation between physiological changes within the brain and the benefits of music therapy for patients afflicted with Parkinson's disease (PD). This study will report on the changes in neural activities as a result of music intervention in PD.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Music Therapy; fNIRS; Controlled Trials; Explicit & Implicit Timing; Motor Control; Synchronous finger tapping

Outcome Measures

Primary Outcomes (4)

• Change from Functional Near-infrared Spectroscopy from baseline

  An ETG-4000 fNIRS system will be used to measure hemoglobin (HBO2) levels in the participant as they perform finger motor control timing assessments. A change, specifically a reduction of HBO2 activation, from baseline measurements indicates reduced cortical activation and suggests improved PD-related symptoms.

  Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)

• Change in Synchronous Finger Motor Control Timing Abilities from baseline

  Participants will be asked to tap their right index finger on a standard QWERTY keyboard "1" key when a visual cue appears. The response time for tapping the "1" key, in response to seeing the visual cue, will be measured to assess motor-timing control. Accuracy of response will be dependent on minimizing early or delayed taps (measured in milliseconds) in congruence with the determined rhythm. A change in score, particularly greater accuracy in timing, from baseline indicates better or improved motor control performance.

  Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)

• Change in Continuous Finger Motor Control Timing Abilities from baseline

  Participants will be asked to tap their right index finger on a standard QWERTY keyboard "1" key when a visual cue appears. The participants will then be asked to maintain the tapping rhythm without the visual cue for 15 seconds. The timing of tapping the "1" key, without the visual cue, will be measured to assess motor-timing control. Accuracy of response will be dependent on minimizing early or delayed taps (measured in milliseconds) in congruence with the determined rhythm. A change in score, particularly greater accuracy in timing, from baseline indicates better or improved motor control performance.

  Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)

• Change in Unified Parkinson Disease Rating Scale (UPDRS) from baseline

  UPDRS objectively assesses the severity of PD based off the disease's burden on the individual and can describe disease progression and treatment response. A total of 42 ratings are split between multiple categories. Examples of categories measured include mental impairments (mood and intelligence), activities in daily living (speech, salivation, level of independence to perform normal tasks such as turning in bed), motor skills (facial, tremor severity in extremities, rigidity) and other complications. Each category has a 0-4 rating determined by the examiner and summed, where a higher score reflects greater disability (maxed at 195 points). A change in the score, i.e. lower score from baseline, indicates beneficial effects of the intervention.

  Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)

Secondary Outcomes (2)

• Montreal Cognitive Assessment (MoCA)

  Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)

• n-Back Working Memory Assessment

  Week 0 (baseline), week 4 (during), week 8 (end), and week 12 (follow-up)

Study Arms (2)

Music Therapy

EXPERIMENTAL

This group will be asked to practice a rhythmic auditory SFT intervention task at home.

Other: Music Therapy

No Music Therapy

NO INTERVENTION

This group will not engage in an intervention task at home and will be asked to continue their normal daily routine.

Interventions

Music Therapy OTHER

Participants in the intervention arm will be asked to practice a rhythmic auditory synchronous finger tapping intervention task at home for a total of 25 minutes split between two ten-minute sets with a five-minute break between the sets every day for 8-weeks. During training sessions participants must listen to the instrumental of a pre-selected well-known Chinese melody, "Moonlight over the Lotus Pond" by Phoenix Legend, whose melody duration is 259s. This song was selected for its strong beat and familiarity to the participants. Participants must follow the beats of the melody and tap their right index finger simultaneously to the beats. A visual cue will be displayed to indicate the beats, identical to the one in the assessment. The training session will be conducted once daily after patients have taken their medication. Participants' primary caretaker will be asked to monitor and record completion of sessions.

Music Therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 40-80 years old, both genders, and right handed;
• Clinical diagnosis of idiopathic PD according to the 2015 Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease;
• Rated as stage I to II on the Hoehn and Yahr scale;
• Scores greater than 21 points on the Montreal Cognitive Assessment (MoCA);
• Maintain a stable dosing of anti-PD or deep-brain stimulation (DBS) treatment throughout the duration of the study;
• Able to travel to and participate in the data collection process.

You may not qualify if:

• Presence of significant hearing or visual impairments;
• Extensive previous musical training;
• A history of any other neurological condition (i.e. Alzheimer's disease, epilepsy, stroke) or psychiatric disorders (i.e. major depression, psychoses).

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead
• Dalian University of Technology: collaborator
• University of California, Irvine: collaborator

Study Sites (1)

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

RECRUITING

Related Publications (1)

• Pu L, Qureshi NK, Ly J, Zhang B, Cong F, Tang WC, Liang Z. Therapeutic benefits of music-based synchronous finger tapping in Parkinson's disease-an fNIRS study protocol for randomized controlled trial in Dalian, China. Trials. 2020 Oct 16;21(1):864. doi: 10.1186/s13063-020-04770-9.

  PMID: 33066811 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Zhanhua Liang, MD

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

• Bingwei Zhang, MD

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

• Fengyu Cong, PhD

  Dalian University of Technology

  PRINCIPAL INVESTIGATOR

• William C Tang, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lanlan Pu, MD

CONTACT

180 9887 2622; pulanlan_2005@163.com

Zhanhua Liang, MD

CONTACT

180 9887 7717; zhanhualiang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients and the outcomes assessor are blinded in this study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 30, 2019
• Study Start: January 18, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: August 23, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)