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Clinical Validation of diagnostic device for Parkinson disease detection

Clinical Validation of Novel Dual PAD ( Microfluidic Device) for screening of Parkinson disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/05/053256
Enrollment
300
Registered
2023-05-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders

Interventions

Control Intervention1: NIL: NIL Control Intervention2: NIL: NIL

Sponsors

Yenepoya Foundation for Technology Incubation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males or females greater than or equal to 60 years of age 2. Willing and able to comply with procurement of Urine sample 3. Possible/Probable Clinical Diagnosis of Parkinson Disease 4. Presenting with at least 3 of the 4 below symptoms/signs: Tremor, Slowed movement,Rigid muscles,Impaired posture and balance.

Exclusion criteria

Exclusion criteria: 1. Any medical, psychiatric or other conditions which, in the opinion of the investigator, would preclude participation 2. None of the features below suggestive of alternative diagnoses is present: o Prominent postural instability in the first 3 years after symptom onset o Freezing phenomena in the first 3 years o Hallucinations unrelated to medications in the first 3 years o Dementia preceding motor symptoms or in the first year o Supranuclear gaze palsy (other than restriction of upward gaze) or slowing of vertical saccades o Severe symptomatic dysautonomia unrelated to medications o Documentation of a condition known to produce parkinsonism and plausibly connected to the patientâ??s symptoms (such as suitably located focal brain lesions or neuroleptic use within the past 6 months)

Design outcomes

Primary

MeasureTime frame
Establishing the correlation between clinical study and developed point of care diagnosis deviceTimepoint: 6 month

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactDr Salma Suhana

Yenepoya(Deemed to be university)

ksprasadnair@yenepoya.edu.in91-9544340364

Outcome results

None listed

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