Group Drum-Based Music Therapy Intervention for Parkinson's Disease/Huntington's Disease

NCT05157074 | Completed

• 1 other identifier: IRB00147450
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Participants in this study (18-89 years) with Parkinson's disease or Huntington's disease receive drum classes twice a week for 12 weeks (24 lessons). All participants also participate in study visits for assessments before the beginning of the study, at the 6 week mark, at the 12 week mark and at the 18 week mark so that the investigators can assess the short and long term effects of drum classes on hand dexterity, upper extremity function and well-being.

Conditions

Parkinson Disease; Huntington Disease

Keywords

group drumming; music therapy; motor function; quality of life; cognition; social and emotion; caregiver burden

Outcome Measures

Primary Outcomes (8)

• Changes in score on anxiety level as assessed by Neuro-QoL (patients and study partner)

  Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For anxiety domain, unpleasant thoughts and/or feelings related to fear (e.g., fearfulness, feelings of panic), helplessness, worry and hyperarousal (e.g., tension, nervousness, restlessness) are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate worse (undesirable) self-reported health.

  Baseline, 6 weeks, 12 weeks, and 18 weeks

• Changes in score on depression level as assessed by Neuro-QoL (patients and study partner)

  Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For depression domain, experience of loss and feelings of hopelessness, negative mood (e.g., sadness, guilt), decrease in positive affect (e.g., loss of interest), information-processing deficits (e.g., problems in decision-making), negative views of the self (e.g., self-criticism, worthlessness), and negative social cognition (e.g., loneliness) are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate worse (undesirable) self-reported health.

  Baseline, 6 weeks, 12 weeks, and 18 weeks

• Changes in score on upper extremity performance level as assessed by Neuro-QoL (patients and study partner)

  Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For upper extremity domain, one's ability to carry out various activities involving digital, manual and reach-related functions, ranging from fine motor to self-care (activities of daily living) are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate better (desirable) self-reported health.

  Baseline, 6 weeks, 12 weeks, and 18 weeks

• Changes in score on lower extremity performance level as assessed by Neuro-QoL (patients and study partner)

  Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For lower extremity domain, one's ability to carry out various activities involving the trunk region and increasing degrees of bodily movement, ambulation, balance, or endurance are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate better (desirable) self-reported health.

  Baseline, 6 weeks, 12 weeks, and 18 weeks

• Changes in score on ability to participate in social roles and activities as assessed by Neuro-QoL (patients and study partner)

  Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For the ability to participate in social roles and activities domain, degree of involvement in one's usual social roles, activities and responsibilities, including work, family, friends, and leisure are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate better (desirable) self-reported health.

  Baseline, 6 weeks, 12 weeks, and 18 weeks

• Changes in score on satisfaction with social roles and activities as assessed by Neuro-QoL (patients and study partner)

  Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For the satisfaction with social roles and activities domain, satisfaction with involvement in one's usual social roles, activities and responsibilities, including work, family, friends, and leisure are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate better (desirable) self-reported health.

  Baseline, 6 weeks, 12 weeks, and 18 weeks

• Changes in score on positive affect and well-being level as assessed by Neuro-QoL (patients and study partner)

  Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For positive affect and well-being domain, aspects of a person's life that relate to a sense of well-being, life satisfaction or an overall sense of purpose and meaning are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate better (desirable) self-reported health.

  Baseline, 6 weeks, 12 weeks, and 18 weeks

• Changes in score on burden level as assessed by the Zarit Burden Interview (ZBI) (study partner)

  The Zarit Burden Interview, a popular caregiver self-report measure used by many aging agencies, originated as a 29-item questionnaire. The 29-item instrument is included in Zarit et al., 1980. The revised version contains 22 items. This study used 22 items. It is scored as either (0) never, (1) rarely, (2) sometimes, (3) quite frequently, or (4) nearly always. Items are then summed and total scores are interpreted as follows: 0 to 21 little or no burden, 21 to 40 mild to moderate burden, 41 to 60 moderate to severe burden, and 61 to 88 severe burden.

  Baseline, 6 weeks, 12 weeks, and 18 weeks

Secondary Outcomes (10)

• Changes in score on cognitive impairment level as assessed by the MoCA (patients)

  Baseline, 6 weeks, 12 weeks, and 18 weeks

• Change in score on depression level as assessed by the BDI-II (patients and study partner)

  Baseline, 6 weeks, 12 weeks, and 18 weeks

• Changes in score on the daily living level as assessed by Parkinson's Disease Questionnaire (PDQ-39) (patients)

  Baseline, 6 weeks, 12 weeks, and 18 weeks

• Changes in score on patient health level as assessed by the short form (SF)-36 (patients and study partner)

  Baseline, 6 weeks, 12 weeks, and 18 weeks

• Changes in score on apathy level as assessed by Apathy Evaluation Scale (patients)

  Baseline, 6 weeks, 12 weeks, and 18 weeks

Study Arms (2)

Parkinson's Disease (PD) Group

EXPERIMENTAL

Participants with PD and their caregivers receive group drum classes twice a week for 12 weeks (24 lessons).

Behavioral: Group Drumming Music Therapy

Huntington's Disease (HD) Group

EXPERIMENTAL

Participants with HD and their caregivers receive group drum classes twice a week for 12 weeks (24 lessons).

Behavioral: Group Drumming Music Therapy

Interventions

Group Drumming Music Therapy BEHAVIORAL

All 24 Armstrong Rhythm Cycle™ sessions is conducted in a circle to ensure maximum line of sight for each participant. A variety of diverse percussion instruments ranging from hand drums, stick drums, shakers, and rhythm sticks are available as well as adaptive measures to address limited physical functioning. Instrument choice is dependent on ease of use for the level of the physical ability, skill development needs, and personal choice. Participants are informed that the participants free to use the same instrument for the duration of each session or to switch instruments at any time. Utilizing the five components of The Armstrong Rhythm Method, this protocol guides participants through three phases to achieve rhythmic skill development and group cohesion for therapeutic benefit.

Huntington's Disease (HD) Group; Parkinson's Disease (PD) Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Parkinson's Disease (PD) and Huntington's Disease (HD)
• Ability to give written consent
• Age 18-90
• Clinical diagnosis of probable of clinically established Parkinson disease; or Huntington disease confirmed by genetic testing (greater than or equal to 36 CAG repeats)
• Ability to move hands, wrists and arms safely for instrument play
• Presence of study partner who is available for all drum lessons and study assessments
• Study Partners:
• Ability to give written consent
• Ability to give written consent
• Age 18-90
• Ability to move hands, wrists and arms safely for instrument play

You may not qualify if:

• PD: Hoehn \& Yahr Stage 5 disease; Schwab \& England score 40% or lower
• HD: Total Functional Capacity scores between 5 and 13 inclusive
• Co-morbid diagnosis (broken bones, sprains, severe arthritis, conditions involving paresis) in the judgement of the patient's treating physician that may preclude participant's full ability to participate in the intervention group.
• MoCA scores \<17
• Active psychosis or other condition affecting the participants' ability to safely cooperate with study procedures

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location

Related Publications (10)

• Pantelyat A, Syres C, Reichwein S, Willis A. DRUM-PD: The use of a drum circle to improve the symptoms and signs of Parkinson's disease (PD). Mov Disord Clin Pract. 2016 May-Jun;3(3):243-249. doi: 10.1002/mdc3.12269. Epub 2015 Dec 21.

  PMID: 27340683 BACKGROUND

• National Institute of Neurological Disorders and Stroke (NINDS). User Manual for the Quality of Life in Neurological Disorders (Neuro-QoL) Measures, Version 2.0, March 2015.

  BACKGROUND

• Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

  PMID: 7203086 BACKGROUND

• Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

  PMID: 19025984 BACKGROUND

• Peto V, Jenkinson C, Fitzpatrick R, Greenhall R. The development and validation of a short measure of functioning and well being for individuals with Parkinson's disease. Qual Life Res. 1995 Jun;4(3):241-8. doi: 10.1007/BF02260863.

  PMID: 7613534 BACKGROUND

• Beck AT, Steer RA, Brown GK. Manual for the beck depression inventory-II.1996

  BACKGROUND

• Marin RS, Biedrzycki RC, Firinciogullari S. Reliability and validity of the Apathy Evaluation Scale. Psychiatry Res. 1991 Aug;38(2):143-62. doi: 10.1016/0165-1781(91)90040-v.

  PMID: 1754629 BACKGROUND

• McRae C, Diem G, Vo A, O'Brien C, Seeberger L. Reliability of measurements of patient health status: a comparison of physician, patient, and caregiver ratings. Parkinsonism Relat Disord. 2002 Jan;8(3):187-92. doi: 10.1016/s1353-8020(01)00009-8.

  PMID: 12039430 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Huntington Disease; Caregiver Burden

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Chorea; Dyskinesias; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Alexander Pantelyat

  Department of Neurology, Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were assigned based on diagnosis, into two intervention groups 1) patients diagnosed with Parkinson's disease and the participant's study partners, 2) patients diagnosed with Huntington's disease.

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: January 9, 2019
• Primary Completion: June 10, 2019
• Study Completion: June 10, 2019
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)