Music and the Brain: A study to understand the effect of Indian Music Rhythm based intervention in patients with parkinsons disease

Phase 1

Conditions: Health Condition 1: G20- Parkinsons disease

Registration Number: CTRI/2020/02/023094

Lead Sponsor: Wellcome Trust India Alliance DBT Intermediate CPHI Fellowship

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

For PD group

1.Diagnosis of PD according to UK Brain Bank diagnostic criteria.

2.Patients from both gender

3.Age range 40 to 65 years.

4.Right Handedness- determined by Edinburgh Handedness Inventory39

5.With formal education of 7 years with fluency in Hindi , English or Kannada

6.Patients with Hoehn and Yahr stage40 1 to 2.5.

7.Normal or corrected vision and hearing.

8.Patients who are adhering to medication /pharmacological treatment and those who have been on stable medication 2-month before recruitment.

For Healty Control group (HC) group

1.Right Handedness- determined by Edinburgh Handedness Inventory39

2.HMSE score (score 24 or above)

3.Age range â?? 40 to 65 years

4.Both gender

5.Adequate hearing and visual ability/ corrected vision and audition

6.With formal education of 7 years with fluency in Hindi, English or Kannada and Right handedness.

7.Fluent in speaking in English/Hindi/Kannada

Exclusion Criteria

For PD group

1.Cognitive impairment assessed by Hindi Mental status examination41 (HMSE score less than 24 )

2.Patient undergoing or those who have undergone any other form of cognitive remediation or any music based therapy in the last 6-months.

3.Any other psychiatric and neurological conditions other than PD.

4.Neurologic or medical disorders interfering with gait or cognition such as previous stroke, head injury, brain tumour, rheumatologic or orthopaedic disorder etc

5.Patients with severe sensory deficits (visual /auditory) which will affect participation in intervention study.

6.Patients with severe level of depression or anxiety as assessed by HADS 42 or clinically evaluated psychotic - severe enough to hinder their participation in intervention as assessed by clinical interview with patient and care giver.

7.Any contraindications for undergoing magnetic resonance imaging

For HC group

1.Formal training more than two years in any form of music

2.History of any Neurological/Psychiatric/Neurosurgical condition. Score of 12 or more Kesslerâ??s 6 Screening Scale (K6)43

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 1- Neurocognitive functions and rhythm perception <br/ ><br>functional connectivity via resting state fMRI <br/ ><br>Phase 2:working memory index) and motor functions (UPDRS-III motor functions scoresTimepoint: Phase 1- Soon after the neuropsychological evaluation and MRI scan <br/ ><br>functional connectivity via resting state fMRI <br/ ><br>Phase 2:At baseline, post 3 month intervention and 6 month follow up period

Secondary Outcome Measures

Name	Time	Method
Phase 1: Music perception and Emotion perception <br/ ><br>Phase 2: <br/ ><br>fMRI-neural correlates and changes in functional connectivity <br/ ><br>Music and rhythm perception, emotion perception, quality of sleep, levels of depression, anxiety and quality of lifeTimepoint: Phase 1: Soon after the neuropsychological evaluation <br/ ><br>Phase 2: Three time points At baseline, 3 month and 6 month follow-up