NCT07236840 Self-administered Remote Neurological Examination Using Mobile Application in Patients With Brain Tumors
| NCT ID | NCT07236840 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tata Memorial Centre |
| Condition | CNS Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-02-20 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2026-02-20 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Diagnosis of brain tumors (histopathology/ radiology). 2. Age \> 5 years 3. Patient or caregiver have access to an android smart phone and is able to install the mobile application. 4. Expected survival more than 6 months during study accrual. 5. Signing patient consent or parent consent/ child assent form (as appropriate). Exclusion Criteria: 1. Patient or caregiver is not reliable to follow instructions or use the mobile application. 2. Patient with severe cognitive or psychiatric issues causing difficulty in using the app or follow instructions. 3. Karnofsky Performance Status (KPS) or Lansky Performance Status LPS) \<50. 4. Terminal illness with expected life expectancy (\<6 months).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07236840 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying CNS Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07236840 currently recruiting?
Yes, NCT07236840 is actively recruiting participants. Contact the research team at archya1010@gmail.com for enrollment information.
Where is the NCT07236840 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT07236840 clinical trial?
NCT07236840 is sponsored by Tata Memorial Centre. The trial plans to enroll 600 participants.