Clinical trial · Observational
Self-administered Remote Neurological Examination Using Mobile Application in Patients With Brain Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence (AI) | — | UNRESOLVED | — |
| CNS Tumor | Central Nervous System Neoplasm | ALIAS | 0.90 |
| Digital Health | — | UNRESOLVED | — |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neurological assessment | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Development of a mobile application equipped with symptom assessment and recording videos as patients perform specific neurological tasks.
- timeFrame
- 2 years
- description
- Correlation between patients self assessment of neurological status utilizing the application and the physician-based evaluation will be done using Cohen kappa statistics.
- measure
- Prediction of neurological status using mobile application
- timeFrame
- 2 years
- description
- Regression analysis of neurological symptoms recorded using application with disease status (recurrence or no recurrence).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available