Neurologic Music Therapy for Parkinson's Disease

Overseen By Lucas Lattanzio, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Cerebrovascular disease, Major head trauma, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Parkinson's Disease (PD) is defined by characteristic motor symptoms including slow movements, small movements, difficulty with movement initiation and disruptions in timing. Besides gross motor symptoms, fine motor impairments in PD cause difficulties with everyday tasks such as writing, self-care, and fine object manipulation. These activity limitations can lead to disability, social isolation, and a reduced quality of life. In a series of breakthrough studies Michael Thaut and colleagues developed Neurologic Music Therapy (NMT) and found it can address many gross motor impairments and improve gait and balance. Other music therapies such as Music-supported Therapy (MST) have proven motor benefits in stroke patients through movement exercises with musical instruments. However, the pathological basal ganglia (BG) in PD brains leads to a reduced supply of those internally generated movements. In contrast, externally cued movements (eg. via a beat or a rhythm) during NMT sessions are instantaneously entrained to the period of a rhythmic stimulus possibly without involvement of the BG. The underlying idea is that rhythm is the essential component relating music specifically to motor behavior. The mechanism of action is called "rhythmic entrainment" where one system's motion or signal frequency entrains the frequency of another system. The effect of NMT on fine motor function has not been investigated yet. Music activities are important in the lives of many older adults. Notably, the use of music has been associated with increased well-being for older adults, as it fosters social connection and mood regulation. Furthermore, many musical activities have limited physical demands, making them attainable for individuals who are living with mobility impairments or other physical restrictions. Based on the literature and the investigators preliminary studies, the investigators propose to test the efficacy of Neurologic Music Therapy in comparison to Music Supported Therapy and Occupational Therapy (OT) as standard of care on adults in the Parkinson's spectrum. The investigators have defined a working plan using different musical instruments and growing tempo to specifically improve fine motor movements.

Will I have to stop taking my current medications?

The trial requires that your medication be stable for at least 30 days, so you should not change your current medications before or during the study.

Is Neurologic Music Therapy safe for humans?

Neurologic Music Therapy (NMT) has been used in various studies for conditions like Parkinson's disease and stroke, and no significant safety concerns have been reported. It is generally considered safe, with some patients declining sessions due to fatigue. ^{1 2 3 4 5}

How is Neurologic Music Therapy different from other treatments for Parkinson's disease?

Neurologic Music Therapy (NMT) is unique because it uses music and rhythm to improve movement and balance in Parkinson's patients, relying on neural pathways that are not affected by the disease. Unlike medications or surgeries, NMT is a non-drug approach that can enhance gait and motor functions through techniques like rhythmic auditory stimulation, which uses external rhythmic cues to aid walking. ^{1 4 5 6 7}

What data supports the effectiveness of the treatment Neurologic Music Therapy for Parkinson's Disease?

Research shows that Neurologic Music Therapy, particularly using rhythmic auditory stimulation, can significantly improve walking and balance in Parkinson's patients, reducing their risk of falls. Additionally, music therapy has been found to help with motor and emotional functions, enhancing overall quality of life for those with Parkinson's disease. ^{1 4 5 7 8}

Who Is on the Research Team?

Isabelle Buard, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

Adults aged 45-85 with Parkinson's Disease, experiencing fine motor impairments, and stable on medication for at least a month can join. Excluded are those with other forms of parkinsonism, inability to move fingers or hands, involvement in other music therapy studies, lack of insurance coverage for Occupational Therapy, advanced Parkinson's (stage 4+), metal implants affecting MEG/MRI data or safety concerns, and dementia.

Inclusion Criteria

Medication stable for at least 30 days.

Diagnosis of Parkinson's Disease using the UK Brain Bank Criteria

I have difficulty with tasks that require small, precise movements.

Exclusion Criteria

I cannot move my fingers or hands.

Participants engaged in other research studies involving music therapies

My Parkinson's symptoms are not due to a stroke or major head injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Neurologic Music Therapy, Music Supported Therapy, or Occupational Therapy for 5 weeks to improve fine motor movements

5 weeks

Weekly sessions

Waitlist Control

Participants in the waitlist-control condition do not receive immediate treatment and wait for 5 weeks before being randomized to receive NMT, MST, or OT

5 weeks

Follow-up

Participants are monitored for changes in motor function and quality of life after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Music Supported Therapy
• Neurologic Music Therapy
• Occupational Therapy

Trial Overview The trial is testing Neurologic Music Therapy (NMT) against Music Supported Therapy (MST) and standard Occupational Therapy (OT). It aims to see if NMT improves fine motor skills in Parkinson’s patients by using musical instruments and rhythm exercises compared to MST and OT.

How Is the Trial Designed?

Group I: Neurologic Music Therapy (NMT) Experimental Treatment 1 Intervention

Neurologic Music Therapy is a 5-week intervention using different musical instruments and auditory cues to specifically improve fine motor movements.

Group II: Occupational Therapy (OT) Active Control 1 Intervention

Standard of care occupational therapy uses traditional motor training.

Group III: Waitlist Control Active Control 1 Intervention

Participants assigned to the waitlist-control condition will not immediately receive services. The no-treatment duration for these participants is yoked to the amount of time their respective NMT- and OT-condition participants receive services (5 weeks). After the wait period, these participants will then be randomized to receive either NMT, MST or OT sessions.

Group IV: Music Supported Therapy (MST) Active Control 1 Intervention

Music Supported Therapy uses musical instruments to train fine motor movements.

Neurologic Music Therapy is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Neurologic Music Therapy for:

• Rehabilitation for Parkinson's disease
• Stroke rehabilitation
• Traumatic brain injury rehabilitation

Approved in Canada as Neurologic Music Therapy for:

• Rehabilitation for Parkinson's disease
• Stroke rehabilitation
• Traumatic brain injury rehabilitation

Approved in European Union as Neurologic Music Therapy for:

• Rehabilitation for Parkinson's disease
• Stroke rehabilitation
• Traumatic brain injury rehabilitation

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

This study proposes a daily 25-minute music-based synchronous finger tapping intervention for 8 weeks in patients with Parkinson's disease, aiming to improve neuronal activity and connectivity.

The effectiveness of the intervention will be assessed through various measures, including finger tapping performance and brain activity using functional near-infrared spectroscopy, with the goal of informing larger clinical studies on music therapy's therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic benefits of music-based synchronous finger tapping in Parkinson's disease-an fNIRS study protocol for randomized controlled trial in Dalian, China. Pu, L., Qureshi, NK., Ly, J., et al.[2021]

Active music therapy (MT) significantly improved motor functions, particularly bradykinesia, in patients with Parkinson's disease, as evidenced by a notable reduction in scores on the Unified Parkinson's Disease Rating Scale after 3 months of therapy.

MT also enhanced emotional functions and quality of life, with substantial improvements reported on the Happiness Measure and the Parkinson's Disease Quality of Life Questionnaire, suggesting its potential as a valuable addition to rehabilitation programs for Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active music therapy in Parkinson's disease: an integrative method for motor and emotional rehabilitation. Pacchetti, C., Mancini, F., Aglieri, R., et al.[2022]

Neurologic music therapy (NMT), specifically using rhythmic auditory stimulation (RAS), has been shown to significantly improve gait and balance in elderly patients with Parkinson's disease and stroke, based on a review of 8 randomized controlled trials.

The studies indicate that RAS not only enhances mobility but also reduces the risk of falls in Parkinson's disease patients, highlighting its potential as an effective non-pharmacological rehabilitation technique for geriatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurologic Music Therapy in Geriatric Rehabilitation: A Systematic Review. Rusowicz, J., Szczepańska-Gieracha, J., Kiper, P.[2022]

Rhythmic auditory stimulation, which uses music or rhythmic cues, has been shown to effectively improve walking function in patients with Parkinson's disease and other neurological disorders, both during therapy sessions and over time.

Melodic intonation therapy can enhance speech abilities in patients with expressive dysphasia and supports rehabilitation for conditions like Parkinson's disease and stroke, highlighting the therapeutic potential of music-based interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Can music therapy for patients with neurological disorders?]. Myskja, A.[2008]

Recent studies show that rhythmic auditory stimulation can significantly improve gait parameters in Parkinson's disease, including reducing gait freezing and potentially lowering the risk of falls.

There is emerging evidence that music therapy, including group dancing and singing, may provide both motor and non-motor benefits for patients with Parkinson's disease and other movement disorders, although more rigorous research is needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music Therapy and Music-Based Interventions for Movement Disorders. Devlin, K., Alshaikh, JT., Pantelyat, A.[2020]

Participants with brain injuries who underwent four sessions of neurologic music therapy (NMT) showed significant improvements in executive function and emotional adjustment, along with reductions in depression, anxiety, and sensation seeking.

In contrast, control participants who rested instead of receiving NMT experienced declines in memory and positive affect, highlighting the potential benefits of NMT for cognitive and emotional rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurologic music therapy improves executive function and emotional adjustment in traumatic brain injury rehabilitation. Thaut, MH., Gardiner, JC., Holmberg, D., et al.[2009]

A two-day per week Neurologic Music Therapy (NMT) service over 24 months was found to be feasible and well-accepted by patients, relatives, and staff, with high helpfulness ratings (patients: 3.34, relatives: 3.83, staff: 3.85 on a scale of 1 to 4).

Patients showed a non-significant trend towards improved mood after sessions, with a reduction in feelings of sadness and an increase in happiness, suggesting that NMT may enhance engagement in rehabilitation for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurologic music therapy in multidisciplinary acute stroke rehabilitation: Could it be feasible and helpful? Street, A., Zhang, J., Pethers, S., et al.[2021]

This study will evaluate the efficacy of Therapeutic Instrumental Music Performance (TIMP) techniques, both with and without rhythm, in improving fine motor function in 100 Parkinson's disease patients over 15 sessions, compared to standard occupational therapy and a control group.

The research aims to uncover the underlying brain mechanisms involved in these interventions using magnetoencephalography, potentially demonstrating that NMT engages compensatory brain networks that help bypass the dysfunctional areas affected by Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of neurologic music therapy in Parkinson's disease: research rehabilitation protocols for mechanistic and clinical investigations. Buard, I., Lattanzio, L., Stewart, R., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Therapeutic benefits of music-based synchronous finger tapping in Parkinson's disease-an fNIRS study protocol for randomized controlled trial in Dalian, China. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Active music therapy in Parkinson's disease: an integrative method for motor and emotional rehabilitation. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Neurologic Music Therapy in Geriatric Rehabilitation: A Systematic Review. [2022]

4. Norway pubmed.ncbi.nlm.nih.gov

[Can music therapy for patients with neurological disorders?]. [2008]

5. United States pubmed.ncbi.nlm.nih.gov

Music Therapy and Music-Based Interventions for Movement Disorders. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Neurologic music therapy improves executive function and emotional adjustment in traumatic brain injury rehabilitation. [2009]

7. England pubmed.ncbi.nlm.nih.gov

Neurologic music therapy in multidisciplinary acute stroke rehabilitation: Could it be feasible and helpful? [2021]

8. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of neurologic music therapy in Parkinson's disease: research rehabilitation protocols for mechanistic and clinical investigations. [2021]