Clinical trial NCT05157074: Group Drum-Based Music Therapy Intervention for Parkinson's Disease/Huntington's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Huntington Disease
Keywords: group drumming
music therapy
motor function
quality of life
cognition
social and emotion
caregiver burden
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned based on diagnosis, into two intervention groups 1) patients diagnosed with Parkinson's disease and their study partners, 2) patients diagnosed with Huntington's disease.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in score on anxiety level as assessed by Neuro-QoL (patients and study partner)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: Changes in score on depression level as assessed by Neuro-QoL (patients and study partner)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: Changes in score on upper extremity performance level as assessed by Neuro-QoL (patients and study partner)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: Changes in score on lower extremity performance level as assessed by Neuro-QoL (patients and study partner)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: Changes in score on ability to participate in social roles and activities as assessed by Neuro-QoL (patients and study partner)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: Changes in score on satisfaction with social roles and activities as assessed by Neuro-QoL (patients and study partner)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: Changes in score on positive affect and well-being level as assessed by Neuro-QoL (patients and study partner)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: Changes in score on burden level as assessed by the Zarit Burden Interview (ZBI) (study partner)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
Secondary outcomes:
measure: Changes in score on cognitive impairment level as assessed by the MoCA (patients)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: Change in score on depression level as assessed by the BDI-II (patients and study partner)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: Changes in score on the daily living level as assessed by Parkinson's Disease Questionnaire (PDQ-39) (patients)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: Changes in score on patient health level as assessed by the short form (SF)-36 (patients and study partner)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: Changes in score on apathy level as assessed by Apathy Evaluation Scale (patients)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: 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)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: 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)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: 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)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: 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)
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
measure: Changes in score on activities of daily living level as assessed by the Schwab and England scale
timeFrame: Baseline, 6 weeks, 12 weeks, and 18 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Department of Neurology, Johns Hopkins School of Medicine
name: Alexander Pantelyat
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1093/geront/20.6.649. No abstract available.
citation: 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.
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. doi: 10.1007/BF02260863.
citation: Beck AT, Steer RA, Brown GK. Manual for the beck depression inventory-II.1996
citation: 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.
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. doi: 10.1016/s1353-8020(01)00009-8.
citation: 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.
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.