Assessment of Autonomic Dysfunction in Parkinsons Disease by Heart Rate Variability
- Conditions
- Health Condition 1: G20- Parkinsons disease
- Registration Number
- CTRI/2023/05/052285
- Lead Sponsor
- HBT Medical College Dr RN Cooper Hospital Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Heart rate variability to assess autonomic functions will be studied in 65 consecutive
patients presenting with idiopathic PD according to the MDS-PD criteria, age 30-60
years visiting neurology outpatient department of Municipal General Hospital. Prior
approval of ethics committee will be taken and informed consent obtained from the
patients. Patients without any concomitant cardiovascular disease as confirmed by physical examination and normal 12-lead ECG will be included in the study.
Patients suspected of atypical/ secondary Parkinsonism as per MDS-PD criteria will be excluded from the study. Patients with dementia (as assessed by Mini Mental
State Scale) that would affect their ability to provide consent and reliable self
report will be excluded from the study. Patients with other medical conditions or co-morbidities or drugs as assessed by history, clinical examination and previous investigations known to affect autonomic nervous system or heart rate variability will be excluded from the study.
1. Atypical/ secondary Parkinsonism
2. Significant neurological disease such as stroke or epilepsy
3. Diabetes mellitus
4. Coronary artery disease / heart failure / myocardial infarction
4. Dyslipidemia, Hypertension
5. History of smoking/ alcohol intake
6. Broncho- pulmonary disease, dypnea.
7. Amyloidosis/ neuropathy
8.Patients who had medication known to influence autonomic system and biological rhythms will also be excluded from the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -To evaluate autonomic dysfunction in Parkinsons disease patients by linear and non-linear indices of short-term heart rate variability. <br/ ><br>Timepoint: 3 years
- Secondary Outcome Measures
Name Time Method - To evaluate the predictive value of heart rate variability for autonomic dysfunction in Parkinsons disease by using Receiver operated curve (ROC).Timepoint: 3 years;To co-relate heart rate variability parameters with autonomic symptoms, duration and severity of disease, levodopa/levodopa equivalent dose in Parkinsons disease patients.Timepoint: 3 years