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Evaluation of association of Parkinsons Disease symptoms with urinary vesicles(exsomes).

Evaluation of association of Parkinsons Disease symptoms with urinary extracellular vesicles

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/06/033946
Enrollment
100
Registered
2021-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

None listed

Sponsors

DrDinesh Upadhya
Lead Sponsor
DrDhiren Punja HOD Physiology
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients will be enrolled from neurology OPD of Kasturba Hospital Manipal. Patients satisfying the UK PD Brain Bank criteria for idiopathic PD will be included after clinical evaluation by a movement disorder specialist. Criteria includes bradykinesia and at least 1 of the following Muscular rigidity; 4-6Hz resting tremor; postural instability not caused by a primary visual ,vestibular,cerebellar or proprioceptive dysfunction following the exclusion of other causes of Parkinsonism. Additionally, 3 or more features that supported a diagnosis of PD including: a unilateral onset and presence of a resting tremor, a progressive disorder, Persistent asymmetry maximally affecting the side of onset, Excellent response to levodopa and presence of severe levodopa induced chorea.

Exclusion criteria

Exclusion criteria: atypical Parkinsonism, secondary Parkinsonism, h/o repeated Strokes, intake of antipsychotics,mini-mental state examination score <24, presence of cerebral tumor or communicating hydrocephalus,negative response to large doses of Levodopa(if malabsorption is excluded,exposure to 1-methyl4- phenyl2,3,6tetrahydropyridine(MPTP), patients who refused or were unable to give consent

Design outcomes

Primary

MeasureTime frame
In MDS UPDRS, extent and burden of PD will be measured.In MDS NMSS, severity and frequency of NMSs across 9 dimensions will be measured.In urinary Evs, total number of Evs, their size and concentration of proteins will be measured. The generated data will help us to understand the association between PD symptoms with urinary EV proteins. If we find a clear association with any specific parameter of EVs with NMS symptoms, further studies can be taken upTimepoint: Urinary exosomes will be isolated immediately.Isolated exosomes will be stored at -80 and analyzed in batches within a week.

Secondary

MeasureTime frame
relation of non motor symptoms to motor symptoms will also be statistically analyzed.this will be done in a Tertiary care hospital setting in Manipal,KarnatakaTimepoint: Urinary exosomes will be isolated immediately.Isolated exosomes will be stored at -80 and analyzed in batches within a week. it will take 1.5 hours to fill up questionnaire and scale and data collected will be analyzed simultaneously

Countries

India

Contacts

Public ContactDrDinesh Upadhya

KMC Manipal

dushyanth.jasti@manipal.edu9704464455

Outcome results

None listed

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