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

Sponsor
Tata Memorial Centre
Study ID
NCT07236840
Status
Recruiting
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Conditions

  • Artificial Intelligence (AI)
  • CNS Tumor
  • Digital Health
  • Glioma

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

First listed
Nov 19, 2025
Start date
Feb 20, 2026
Status verified
Feb 2026
Primary completion
Nov 1, 2027
Completion
Nov 5, 2027

Study Design

Enrollment
600 participants (estimated)

Primary Outcome Measure

Development of a mobile application equipped with symptom assessment and recording videos as patients perform specific neurological tasks. [ Time Frame: 2 years ]

Central Contacts

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