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Brain-Heart Stress Response in Parkinsons Disease

Multimodal noninvasive recording and analysis of autonomic and cognitive stress response in Parkinsons disease patients: an experimental brain-heart interaction study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086870
Enrollment
80
Registered
2025-05-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G20- Parkinsons disease

Interventions

Intervention1: Cognitive Stress Stimulus: Description: A computerized Eriksen Flanker task designed to assess cognitive control and induce cognitive stress, presented in 4 blocks for a total of 20 min

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The age group of the patients for the study should be between 40 to 70 years Only the participants with a MOCA questionnaire-based Montreal Cognitive Assessment score of 23 or more would be recruited in this study. Only Idiopathic Parkinsons patients would be recruited in the study to maintain the homogeneity of the sample. All patients would be recruited during the drug-off status or as the early diagnosed patients where conventional drug regimen has not yet started Treatment naive group. Parkinsons patients with insomnia and Restless leg syndrome shall be included and will be then considered as covariates for the analysis of the results Patients with normal ECG and echocardiography

Exclusion criteria

Exclusion criteria: Other neurological diseases (ie, epilepsy, multiple sclerosis, autonomic neuropathy). Known severe cardiac diseases (ie, history of heart disease, severe cardiac insufficiency, heart failure, cardiac pacemaker, valvular defect, with or without stent implantation, heart attack). History of Stroke, Mental disorders (ie, schizophrenia, depression) [moderate to severe cases with depression (to be administered DASS-21 depression questionnaire)]. [Those with mild depression shall only be recruited in the study]. Orthopaedic diseases (ie, bone fracture in last 6 months, symptomatic slipped disc). Muscular diseases (ie, myositis, tendovaginitis). Severe endocrinologic diseases (ie, manifest hypothyroidism or hyperthyroidism, adiposity (BMI more than 30), juvenile-onset diabetes, Type-2 diabetes). Injury or surgery in last 6 months. Using one of the following medications: beta blocker, angiotensin-converting- enzyme inhibitor, antiarrhythmic drugs, neuroleptics, narcotic analgesics, benzodiazepines and psychoactive medications. Use of illegal intoxicants or alcohol abuse (harmful use)

Design outcomes

Primary

MeasureTime frame
To compare neurophysiological responses to cold pressor and mental stress tests in patients with Parkinsonism and healthy controls using: Heart rate variability (HRV) Functional near-infrared spectroscopy (fNIRS) Quantitative EEG parametersTimepoint: 5 min of cold pressor test and after every 5-min block of cognitive tests (4 blocks)

Secondary

MeasureTime frame
To evaluate cardiac autonomic recovery following cold pressor and mental stress tests using standard image-based autonomic reactivity and recovery testsTimepoint: Up to 10 minutes post-stimulus;To assess resting-state EEG microstates in patients with Parkinsonism and in healthy controlsTimepoint: At baseline (prior to stress tests);To correlate central oscillatory activity with peripheral autonomic indices in patients with Parkinsonism and healthy controlsTimepoint: At rest and during stress tasks

Countries

India

Contacts

Public ContactDr Poorvi Kulshreshtha

All India Institute of Medical Sciences

poorvi77@gmail.com8126182374

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026