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

Parkinson Disease Clinical Trial

Official title:

Drum-PD/HD: The Impact of Group Drum-Based Music Therapy Intervention on Quality of Life and Motor Symptoms in Parkinson's Disease and Huntington's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05157074
• Other study ID #: IRB00147450
• Status: Completed
• Phase: N/A
• Start date: January 9, 2019
• Est. completion date: June 10, 2019

Study information

• Verified date: December 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

There has been evidence that rhythm-based music therapy interventions may improve motor outcomes for patients with Parkinson's disease and Huntington's disease, as well as quality of life for both patients and the patients' caregivers. DRUM-PD, a pilot study investigating the impact of West African drumming on quality of life, symptoms, motor findings, cognition, and mood in Parkinson's disease, found trends toward improvement in walking from baseline to 12 weeks and improved quality of life for patients who completed the 6 week drumming intervention. Building on this research, the investigators plan to evaluate the impact of a 12-week, twice weekly rhythm-based music therapy intervention called The Armstrong Rhythm Cycle℠, implemented by a board-certified music therapist. The investigators hypothesize that participation in 24 bi-weekly, hour-long music therapy drumming sessions will result in improved motor functioning for patients and better quality of life for patients and the patients' caregivers as compared to baseline before the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 10, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Huntington Disease
• Parkinson Disease

Intervention

Behavioral:
• Group Drumming Music Therapy
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 they are 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 their therapeutic benefit.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

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. — View Citation

Marin RS, Biedrzycki RC, Firinciogullari S. Reliability and validity of the Apathy Evaluation Scale. Psychiatry Res. 1991 Aug;38(2):143-62. — View Citation

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. — View Citation

Nasreddine ZS, Phillips NA, Bédirian 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. Erratum in: J Am Geriatr Soc. 2019 Sep;67(9):1991. — View Citation

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.

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. Epub 2015 Dec 21. — View Citation

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. — View Citation

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. — View Citation

Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Changes in score on cognitive impairment level as assessed by the MoCA (patients)	Montreal Cognitive Assessment (MoCA) is a rapid cognitive screening test that assesses cognitive performance in multiple domains including visuo-spatial and executive functions, naming, memory, attention, language, abstraction, and orientation. Scores on the MoCA range from 0 to 30: > 26 = normal 18-25 = mild cognitive impairment 10-17 = moderate cognitive impairment <10 = severe cognitive impairment.	Baseline, 6 weeks, 12 weeks, and 18 weeks
Secondary	Change in score on depression level as assessed by the BDI-II (patients and study partner)	Beck-Depression inventory (BDI-II) measures characteristic attitudes and symptoms of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score for the Beck Depression Inventory-II (BDI-II).; There is a four-point scale for each item ranging from 0 to 3. On two items (16 and 18) there are seven options to indicate either an increase or decrease of appetite and sleep. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.	Baseline, 6 weeks, 12 weeks, and 18 weeks
Secondary	Changes in score on the daily living level as assessed by Parkinson's Disease Questionnaire (PDQ-39) (patients)	The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. It also assesses the impact of Parkinson's on specific dimensions of functioning and wellbeing 5 point ordinal scoring system (lower scores reflect better QoL) 0 = never; = occasionally; = sometimes; = often; = always	Baseline, 6 weeks, 12 weeks, and 18 weeks
Secondary	Changes in score on patient health level as assessed by the short form (SF)-36 (patients and study partner)	The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.; The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.; The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 6 weeks, 12 weeks, and 18 weeks
Secondary	Changes in score on apathy level as assessed by Apathy Evaluation Scale (patients)	The Apathy Evaluation Scale addresses characteristics of goal-directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators (18 items).; Items are scored on a 4-point Likert scale (not at all true, slightly true, somewhat true, very true).; Score range: 18-72 (higher scores reflect more apathy)	Baseline, 6 weeks, 12 weeks, and 18 weeks
Secondary	Changes in score on non-motor aspects of experiences of daily living level as assessed by the Movement Disorder Society (MDS) sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Part 1) (patients)	The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. It includes a motor evaluation and characterizes the extent and burden of disease across various populations.; Part 1 includes a total of 13 items.; Items are scored on a 5-point Likert scale (normal, slight, mild, moderate, severe).	Baseline, 6 weeks, 12 weeks, and 18 weeks
Secondary	Changes in score on motor aspects of experiences of daily living level as assessed by the Movement Disorder Society (MDS) sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Part 2) (patients)	The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. It includes a motor evaluation and characterizes the extent and burden of disease across various populations.; Part 2 includes a total of 13 items.; Items are scored on a 5-point Likert scale (normal, slight, mild, moderate, severe).	Baseline, 6 weeks, 12 weeks, and 18 weeks
Secondary	Changes in score on motor examination level as assessed by the Movement Disorder Society (MDS) sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Part 3) (patients)	The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. It includes a motor evaluation and characterizes the extent and burden of disease across various populations.; Part 3 includes a total of 18 items as well as dyskinesia related and Hoehn and Yahr stage items.; Items are scored on a 5-point Likert scale (normal, slight, mild, moderate, severe).	Baseline, 6 weeks, 12 weeks, and 18 weeks
Secondary	Changes in score on motor complications level as assessed by the Movement Disorder Society (MDS) sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Part 4) (patients)	The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. It includes a motor evaluation and characterizes the extent and burden of disease across various populations.; Part 4 includes a total of 6 items.; Items are scored on a 5-point Likert scale (normal, slight, mild, moderate, severe).	Baseline, 6 weeks, 12 weeks, and 18 weeks
Secondary	Changes in score on activities of daily living level as assessed by the Schwab and England scale	The Schwab and England ADL (Activities of Daily Living) scale is a method of assessing the capabilities of people with impaired mobility. The scale uses percentages to represent how much effort and dependence on others people need to complete daily chores. The rating may be given by a professional or by the person being tested.; 0% (fully dependent) to 100% completely independent)	Baseline, 6 weeks, 12 weeks, and 18 weeks