RecruitingNCT07236840

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


Sponsor

Tata Memorial Centre

Enrollment

600 participants

Start Date

Feb 20, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether people with brain tumors — or their caregivers — can use a smartphone app to perform a simplified neurological self-examination at home, allowing doctors to remotely track changes in brain function between clinic visits. **You may be eligible if...** - You have been diagnosed with a brain tumor (confirmed by scan or biopsy) - You are over 5 years old - You or your caregiver has an Android smartphone and can install the app - Your expected survival is more than 6 months **You may NOT be eligible if...** - You or your caregiver cannot reliably follow the instructions or use the app - You have severe cognitive or psychiatric conditions that prevent using the app - You are in very poor health (Karnofsky or Lansky score below 50) - Your life expectancy is less than 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALNeurological assessment

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


Locations(1)

Tata Memorial Centre

Mumbai, Maharashtra, India

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NCT07236840


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