SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL SCIENCES, LUCKNOW

PART – 1: GENERAL INFORMATION

Project Title: Effect of Indian classical music on patients of parkinsonism and its comparison with Western music

Investigators:

                                         Name                      Department                             Signature

Principal Investigator    DR RUCHIKA        NEUROLOGY

        TANDON

Co-investigator              DR SANJEEV         NEUROLOGY

                                             JHA

Student                          DR AJAY                NEUROLOGY

                                             CHAVAN

Total Cost (Rs.):4,96,600/-

Project summary including clearly state objectives (Not Exceed 250 words):

Objectives

Indian classical music, is known to reduce anxiety level like ‘raag bilahari’, improve memory and concentration like ‘raag bhupali’ and induce happiness like ‘raag desh’ in patients, Hence, we aimed to study the effect of these three ragas along with rhythm on improving the motor and non motor symptoms associated with Parkinson plus syndromes and compare them with the effect of Mozart’s Sonata for two pianos K.448 on these patients.

Materials and Methods

Setting

The study shall be conducted in the Department of Neurology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.

Study design

A hospital based musical intervention study.

Duration of study

The study shall be conducted for 8 months.

Key words (at least 5): Mozart’s Sonata; Neurologic Music Therapy; raag bilahari; raag bhupali; raag desh; Parkinson plus syndromes

Copy of the Departmental Research Committee Recommendation-YES

Copy of the Ethics committee submission certificate-YES

(Head of Department will be responsible for periodic monitoring of the project)

PART – 2: TECHNICAL DETAILS

Rationale of the study supported by cited literature (Should state the Hypothesis/Key questions being addressed)

Background and rationale (Review of Literature)

Parkinson disease (PD) is a neurodegenerative disorder with dopamine deficiency characterized by rigidity, slowness, tremors and postural disturbances. People living with PD suffer from both motor and non-motor difficulties [1]. Parkinson plus syndromes patients share some of the clinical features with PD and have additional clinical manifestations as well [2]. Some of them also suffer from memory deficits which affect the quality of their life [3].

Neurostimulation is being used to improve the motor and non-motor symptoms of Parkinson’s disease and Parkinson-plus syndromes [4, 5]. Music is a non-invasive form of neurointervention, which is being employed to treat a number of neurological disorders including epilepsy [6]. Though people are employing music and rhythm-based interventions mainly as cues for improving motor symptoms of Parkinson’s disease, the studies involving music as a form of neurostimulation for managing motor and non-motor manifestations of Parkinson’s disease and Parkinson plus syndromes like progressive supranuclear palsy (PSP), multiple system atrophy (MSA), dementia of Lewy body disease (DLB) and corticobasal syndrome (PSP-CBS) are relatively infrequent [7-11]. According to researchers, music-based motor therapy also called ‘Neurologic Music Therapy (NMT)’ may stimulate activation of auditory and motor cortex in PD patients [12]. Music may reduce tremors in PD patients [13].

Researchers have well studied Mozart’s Sonata for two pianos K.448 for improving neurological symptoms in various neurological disorders like pain and epilepsy [6, 14]. Indian classical music, on the other hand is known to reduce anxiety level like ‘raag bilahari’, improve memory and concentration like ‘raag bhupali’ and induce happiness like ‘raag desh’ in patients [15-17].

The relevance and expected outcome of the proposed study-

Relevance

Though Indian classical music, is known to reduce anxiety level like ‘raag bilahari’, improve memory and concentration like ‘raag bhupali’ and induce happiness like ‘raag desh’ in patients [15-17], we would like to know whether it is better or equally effective than western music in patients of Parkinsonism through this study.

Expected outcome

Indian classical music is associated with improved motor and non-motor outcome in patients of Parkinson-plus syndromes.

Research Question

We would like to know whether Indian classical music is better or equally effective than western music for motor and non-motor manifestations in patients of Parkinson-plus syndromes.

Preliminary work done so far-none

Specific objectives (in bulleted form)

 Objectives

Researchers have well studied Mozart’s Sonata for two pianos K.448 for improving neurological symptoms in various neurological disorders like pain and epilepsy. Indian classical music, on the other hand is known to reduce anxiety level like ‘raag bilahari’, improve memory and concentration like ‘raag bhupali’ and induce happiness like ‘raag desh’ in patients

Study hypothesis

Mozart’s Sonata and raag combining ‘raag bilahari’, ‘raag bhupali’ and ‘raag desh’ may be equally effective in improving the motor and non motor symptoms in Parkinson’s disease.

Hence, we aimed to study the effect of these three ragas along with rhythm on improving the motor and non motor symptoms associated with Parkinson plus syndromes and compare them with the effect of Mozart’s Sonata for two pianos K.448 on these patients.

Work plan methodology/experimental design to accomplish the stated aim including the sample size (Patient/Control/Volunteers) and source of volunteers/Control

Study protocol

Interventions and investigative procedures

We shall perform routine investigations like hemogram, renal and liver function tests, blood sugars and tests for ruling out reversible causes of dementia like thyroid function tests, vitamin B12 and folic acid levels and MRI head with contrast with MRA in all the patients. All the patients will continue to receive medical treatment in the form of levodopa-carbidopa-entacapone and amantadine for Parkinsonism, which we shall not change for these three months, so as to avoid confounders.   

The patients recruited shall be randomised in the following groups using a computer to generate random numbers till 80 and allocating first random numbered patient to group 1, second random numbered patient to group 2 and subsequently to groups 3 and 4 and then repeating this process till all the 80 slots are occupied:

Sample size: 20 patients in each group

A.    Active Indian classical music playing group

Intervention to be done:

Practice all three ragas on Guitar (raag bilahari’ for 10 minutes, followed by rest for 2 minutes, followed by ‘raag bhupali’ for 10 minutes, followed by rest for 2 minutes, followed by ‘raag desh’ for 10 minutes)

Daily x 3 months

B.     Passive Indian classical music listening group

Intervention to be done:

Listen to ragas played on guitar (raag bilahari’ for 10 minutes, followed by rest for 2 minutes, followed by ‘raag bhupali’ for 10 minutes, followed by rest for 2 minutes, followed by ‘raag desh’ for 10 minutes)

Daily x 3 months

C.    Passive Mozart listening group

Listening to Mozart’s sonata for two pianos (K448) daily for 10 minutes for three times with a pause of 2 minutes in between them x 3 months

D.    Non intervention group

No active intervention, only routine treatment

The playing of guitar and supervising of the playing of the guitar shall be done by Mr. Ritesh Singh, who is a trained music teacher.

We shall assess these people at baseline and after the end of 1 month, 2 months and 3 months using UPDRS, MMSE, lobar functions, gait testing, PHQ-9, GAD-7 and also EEG.

The study including the required investigations and music services is proposed to be funded as an Intramural project from the Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.

Outcome measures

Primary outcome:

We would measure primary outcome in terms of improvement or stabilization of UPDRS, MMSE, lobar functions, gait testing, PHQ-9, GAD-7 and also EEG parameters.

Secondary outcome:

Secondary outcome would include any adverse effects noted following music like headache, fatigue, muscle pains or irritability.

Sample size calculation

We get around 30 new patients of Parkinsonism every month and hence, would be able to recruit around 90 patients in 3 months. Assuming that 10 patients would not consent or would not be otherwise fit for the study, we took a total sample size of 80, 20 in all 4 groups.

Statistical analysis

Data will be collected in terms of fixed variables like age, gender, place, duration of disease and continuous variables like UPDRS, MMSE, lobar functions parameters, parameters of gait testing, PHQ-9, GAD-7 and also EEG parameters. We will compare UPDRS, MMSE, lobar functions parameters, parameters of gait testing, PHQ-9, GAD-7 and also EEG parameters among all 4 groups using SPSS 20 at 1 month, 2 months and three months by using parametric and non parametric tests.

Timeline

3 months patient selection, 3 months intervention, 2 months data analysis.

Inclusion/Exclusion criteria

Inclusion criteria

We shall include Parkinson-plus patients visiting the Neurology OPDs and/or emergencies. Hence, we will include patients of Progressive Supranuclear Palsy including PSP-CBS [18], Dementia of Lewy Body disease [19] and Multiple system atrophy [20], who consent for the study. We shall include only those patients who have an MMSE (Mini Mental Status Examination) score of greater than 20, so that they would be able to understand the instructions given to them.

References

1. Sveinbjornsdottir S. The clinical symptoms of Parkinson’s disease. J Neurochem. 2016;139 Suppl 1:318-324.

2. Saeed U, Compagnone J, Aviv RI, Strafella AP, Black SE, Lang AE, et al. Imaging biomarkers in Parkinson’s disease and Parkinsonian syndromes: current and emerging concepts. Transl Neurodegener. 2017;6:8.

3. Levin J, Kurz A, Arzberger T, Giese A, Höglinger GU. The Differential Diagnosis and Treatment of Atypical Parkinsonism. Dtsch Arztebl Int. 2016;113(5):61-69.

4. Schuepbach WM, Rau J, Knudsen K, Volkmann J, Krack P, Timmermann L, et al; EARLYSTIM Study Group. Neurostimulation for Parkinson’s disease with early motor complications. N Engl J Med. 2013;368(7):610-622.

5. Moretti DV. Available and future treatments for atypical parkinsonism. A systematic review. CNS Neurosci Ther. 2019;25(2):159-174.

6. Rafiee M, Patel K, Groppe DM, Andrade DM, Bercovici E, Bui E, et al. Daily listening to Mozart reduces seizures in individuals with epilepsy: A randomized control study. Epilepsia Open. 2020;5(2):285-294.

7. Devlin K, Alshaikh JT, Pantelyat A. Music Therapy and Music-Based Interventions for Movement Disorders. Curr Neurol Neurosci Rep. 2019;19(11):83.

8. Leuk JSP, Low LLN, Teo WP. An Overview of Acoustic-Based Interventions to Improve Motor Symptoms in Parkinson’s Disease. Front Aging Neurosci. 2020;12:243.

9. Koshimori Y, Thaut MH. Future perspectives on neural mechanisms underlying rhythm and music based neurorehabilitation in Parkinson’s disease. Ageing Res Rev. 2018;47:133-139.

10. Buard I, Lattanzio L, Stewart R, Thompson S, Sjoberg K, Hookstadt K, et al. Randomized controlled trial of neurologic music therapy in Parkinson’s disease: research rehabilitation protocols for mechanistic and clinical investigations. Trials. 2021;22(1):577.

11. Ashoori A, Eagleman DM, Jankovic J. Effects of Auditory Rhythm and Music on Gait Disturbances in Parkinson’s Disease. Front Neurol. 2015;6:234.

12. Buard I, Dewispelaere WB, Thaut M, Kluger BM. Preliminary Neurophysiological Evidence of Altered Cortical Activity and Connectivity With Neurologic Music Therapy in Parkinson’s Disease. Front Neurosci. 2019;13:105.

13. Schlesinger I, Benyakov O, Erikh I, Suraiya S, Schiller Y. Parkinson’s disease tremor is diminished with relaxation guided imagery. Mov Disord. 2009;24(14):2059-2062. 

 14. Rossi A, Molinaro A, Savi E, Micheletti S, Galli J, Chirico G, et al. Music reduces pain perception in healthy newborns: A comparison between different music tracks and recoded heartbeat. Early Hum Dev. 2018;124:7-10.

15. Padam A, Sharma N, Sastri OSKS, Mahajan S, Sharma R, Sharma D. Effect of listening to Vedic chants and Indian classical instrumental music on patients undergoing upper gastrointestinal endoscopy: A randomized control trial. Indian J Psychiatry. 2017;59(2):214-218.

16. Nagarajan K, Srinivasan TM, Ramarao NH. Immediate effect of listening to Indian raga on attention and concentration in healthy college students: A comparative study. J Health Res Rev 2015;2:103-107.

17. Sunitha G, Algoodkar S, Smitha PS. Effect of Indian Classical Music Therapy on Depression, Anxiety and Stress Levels in Patients with Depression Measured by DASS-21: A Pilot Study. International Journal of Physiology. 2018;6(2):128-133.

18. Hoglinger GU, Respondek G, Stamelou M, Kurz C, Josephs KA, Lang AE, et al; Movement Disorder Society-endorsed PSP Study Group. Clinical diagnosis of progressive supranuclear palsy: The movement disorder society criteria. Mov Disord. 2017;32(6):853-864.

19. McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, et al. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017;89(1):88-100.

20. Gilman S, Wenning GK, Low PA, Brooks DJ, Mathias CJ, Trojanowski JQ, et al. Second consensus statement on the diagnosis of multiple system atrophy. Neurology. 2008;71(9):670-676.

Curriculum Vitae of the music teacher

Name: Ritesh Singh

Father’s name: Mr. Rajendra Kumar Singh

Date of Birth: 5^th May, 1989

Address: 551 J/87, Ram Prasad Khera, D Cruz Compound, Alambagh, Lucknow. 226005.

Email Id: riteshastro5@gmail.com

Marital status: Single    Gender: Male       Nationality: Indian

Languages known: English, Hindi

Educational qualifications:

Sangeet Prabhakar in guitar (6 years) (2019) from Prayag Sangeet Samiti, Prayagraj

ACDA (Advance Diploma in Computer Application), Computer Hardware Course

B.A. form Kanpur University

Intermediate form U.P. Board

High school from U.P. Board

Strengths: Good communication and leadership skills

Hobbies: Astrology, Guitar, Keyboard

PART – 3 BUDGET PARTICULARS –RS 4,96,600/-

PART – 4 BRIEF BIODATA OF PRINCIPAL INVESTIGATORS

Name: Dr Ruchika Tandon

Designation:Associate Professor

Professional Experience and Training relevant to the project

Publications (Numbers only)-25

Books:16 chapters

Research Papers (Only indexed, not abstract)-25 enclosed

National          12                                            International        13

Patents: …………-………..                                                   (Please Specify)……-……….

Selected peer-received publication in last 5 years (Maximum 5)

PART – 5(A): DETAILS OF PREVIOUS INTRAMURAL PROJECTS