Smartwatch could alert doctors to brain cancer complications before they worsen

NCT ID NCT07704034

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study tests whether a consumer smartwatch (Apple Watch or Samsung Galaxy Watch) can continuously monitor people with leptomeningeal metastasis, a condition where cancer spreads to the fluid and membranes around the brain and spinal cord. The watch collects data on movement and symptoms, and if it detects early signs of neurological decline, it automatically alerts the participant's doctor. The goal is to see if this early warning system can reduce hospitalizations by enabling faster medical intervention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Apple Watch Series 6+ or Samsung Galaxy Watch 4+ with a cross-platform app for passive monitoring and active alerts
What this could lead to
If successful, this approach could provide a way to catch neurological decline early in people with leptomeningeal metastasis, potentially reducing hospital stays and improving quality of life.
What could go wrong
This is a small, early feasibility study, so the smartwatch alerts may not reliably predict decline or reduce hospitalizations. The technology might also be burdensome for participants to use consistently.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must have leptomeningeal metastasis (LMM) diagnosed per clinical, imaging, and/or CSF/cytology criteria (cytology, flow cytometry, or circulating tumor DNA), arising from any solid or hematologic tumor primary. * Participants must be undergoing active anti-cancer therapy (systemic, intrathecal, and/or radiation) or active surveillance for LMM. * Age ≥18 years at the time of study enrollment. Because no safety or dosing data are available for wearable monitoring studies in children with LMM, participants under 18 years of age are excluded. * Karnofsky Performance Status (KPS) ≥50 at time of study enrollment \[See Appendix I\], to ensure feasibility of wearing the device for ≥10 hours/day. * Participants must have access to a compatible smartphone: * iPhone running iOS 16 or higher and willingness to wear Apple Watch ≥10 hours/day; OR * Android smartphone compatible with the study application and willingness to wear Samsung Galaxy Watch ≥10 hours/day. * Ability to provide informed consent (or a legally authorized representative \[LAR\] is available and willing to provide consent on the participant's behalf, if appropriate). Exclusion Criteria: * Anticipated life expectancy \<4 weeks at time of screening, per the treating physician. * Severe dermatologic or musculoskeletal conditions precluding smartwatch wear (e.g., significant skin conditions on the wrist or forearm where the device will be placed, including tattoos that may substantially interfere with optical sensor function). * Inability to adhere to study procedures after training, as assessed by the study team at enrollment. * No access to a compatible smartphone (participant or caregiver) to interface with the watch application for symptom documentation and data transfer. * Inability to give informed consent due to severe aphasia, severe cognitive impairment, or other language barrier, unless a legally authorized representative is available and willing to participate.

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Conditions

The condition(s) this trial relates to.

Meningeal Carcinomatosis neoplastic meningitis Neurologic Manifestations

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106, United States

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