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fNIRS Studies of Music Intervention of Parkinson's Disease

T

The First Affiliated Hospital of Dalian Medical University

Status

Unknown

Conditions

Parkinson Disease

Treatments

Other: Music Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04212897
PJ-KY-2019-123

Details and patient eligibility

About

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.

Full description

Music therapy improves neuronal activity and connectivity of healthy persons and patients with clinical symptoms of neurological diseases like Parkinson's Disease. Despite the plethora of publications that have reported the positive effects of music interventions, little is known about how music improves neuronal activity and connectivity in afflicted patients. In this study, the investigators will use functional near-infrared spectroscopy (fNIRS) to measure oxygenated- (HbO2), deoxygenated- hemoglobin (HbR), and total hemoglobin activation in various parts of the cortex. The fNIRS measurement, in conjunction with the Unified Parkinson's Disease Rating Scale (UPDRS), n-back task, and the Montreal Cognitive Assessment (MoCA), will be performed at baseline, week 4 (during), week 8 (post), and week 12 (retention) of the study. The 8-week long intervention will include a daily 25-minute synchronous finger tapping (SFT) intervention (two sets of ten-minute sessions with a five-minute break in between sets) with a pre-selected well-known rhythmical song. The total anticipated number of participants is 150 and the participants will be split into two groups: an intervention group and a control group. Data collected from the two PD groups will be compared to baseline performances from healthy controls.

Enrollment

150 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • Individuals who do not meet the inclusion criteria;
  • 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

150 participants in 2 patient groups

Music Therapy
Experimental group
Description:
This group will be asked to practice a rhythmic auditory SFT intervention task at home.
Treatment:
Other: Music Therapy
No Music Therapy
No Intervention group
Description:
This group will not engage in an intervention task at home and will be asked to continue their normal daily routine.

Trial contacts and locations

1

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Central trial contact

Lanlan Pu, MD; Zhanhua Liang, MD

Data sourced from clinicaltrials.gov

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