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RECRUITING
NCT07236840

Self-administered Remote Neurological Examination Using Mobile Application in Patients With Brain Tumors

Sponsor: Tata Memorial Centre

View on ClinicalTrials.gov

Summary

The goal of this observational study is to evaluate the feasibility and accuracy of a self-administered remote neurological examination using the "Iskhaa" mobile application in patients with brain tumors aged above 5 years who are able to follow app-based instructions. The main questions it aims to answer are: 1. Development of a mobile application equipped with symptom assessment and recording videos as patients perform specific neurological tasks. 2. Development and validation of the AI model to detect functional changes and predict subsequent neurological deterioration. Participants will: 1. Use the Iskhaa mobile application to perform guided self-neurological examinations following pre-recorded video instructions. 2. Complete EORTC QLQ-C30 and BN20 questionnaires for quality of life assessment. 3. Record and upload videos (e.g., speech, walking, limb movements) using their mobile camera for analysis. 4. In Phase 1 (onsite), 100 participants will use the app under supervision to ensure usability and accuracy. 5. In Phase 2 (offsite), 500 participants will use the app independently at home for monthly self-assessments, with reminders and follow-up support. 6. Continue routine clinic visits every 3-6 months and imaging every 6-12 months as per standard clinical care. The study will compare app-recorded data with physician assessments to determine agreement and validity of remote neurological monitoring using artificial intelligence analysis.

Key Details

Gender

All

Age Range

5 Years - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2026-02-20

Completion Date

2027-11-05

Last Updated

2026-02-24

Healthy Volunteers

No

Interventions

BEHAVIORAL

Neurological assessment

This assessment will include Speech, Cerebellar function and Quality of Life questionnaires using mobile application.

Locations (1)

Tata Memorial Centre

Mumbai, Maharashtra, India