NCT07236840

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. 1.Development of a mobile application equipped with symptom assessment and recording videos as patients perform specific neurological tasks.
  2. 2.Development and validation of the AI model to detect functional changes and predict subsequent neurological deterioration.
  3. 3.Use the Iskhaa mobile application to perform guided self-neurological examinations following pre-recorded video instructions.
  4. 4.Complete EORTC QLQ-C30 and BN20 questionnaires for quality of life assessment.
  5. 5.Record and upload videos (e.g., speech, walking, limb movements) using their mobile camera for analysis.
  6. 6.In Phase 1 (onsite), 100 participants will use the app under supervision to ensure usability and accuracy.
  7. 7.In Phase 2 (offsite), 500 participants will use the app independently at home for monthly self-assessments, with reminders and follow-up support.
  8. 8.Continue routine clinic visits every 3-6 months and imaging every 6-12 months as per standard clinical care.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Feb 2026Nov 2027

First Submitted

Initial submission to the registry

November 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2027

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

November 14, 2025

Last Update Submit

February 21, 2026

Conditions

CNS TumorArtificial Intelligence (AI)GliomaDigital Health

Keywords

neurological examinationmobile applicationbrain tumors

Outcome Measures

Primary Outcomes (2)

  • Development of a mobile application equipped with symptom assessment and recording videos as patients perform specific neurological tasks.

    Correlation between patients self assessment of neurological status utilizing the application and the physician-based evaluation will be done using Cohen kappa statistics.

    2 years

  • Prediction of neurological status using mobile application

    Regression analysis of neurological symptoms recorded using application with disease status (recurrence or no recurrence).

    2 years

Interventions

Neurological assessmentBEHAVIORAL

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

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with brain tumors.

You may qualify if:

  • Diagnosis of brain tumors (histopathology/ radiology).
  • Age \> 5 years
  • Patient or caregiver have access to an android smart phone and is able to install the mobile application.
  • Expected survival more than 6 months during study accrual.
  • Signing patient consent or parent consent/ child assent form (as appropriate).

You may not qualify if:

  • Patient or caregiver is not reliable to follow instructions or use the mobile application.
  • Patient with severe cognitive or psychiatric issues causing difficulty in using the app or follow instructions.
  • Karnofsky Performance Status (KPS) or Lansky Performance Status LPS) \<50.
  • Terminal illness with expected life expectancy (\<6 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

RECRUITING

MeSH Terms

Conditions

Central Nervous System NeoplasmsGliomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain DiseasesCentral Nervous System Diseases

Central Study Contacts

Dr Archya Dasgupta, Radiation Oncology, MD

CONTACT

8097081506archya1010@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Radiation Oncology

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 19, 2025

Study Start

February 20, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 5, 2027

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

IN(1)