HealthyNCT07116759

Head Stabilization of Healthy Volunteers

An observational study of Healthy, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive and since healthy volunteers are enrolled in this study, no radiation is delivered, but in the future, the investigators plan to use this device during radiation treatment with… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Real-time head stabilization with robotic platform
Type of treatment: Medical device
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 9 Oct 2022to 31 Dec 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: The volunteer population will consist of healthy individuals.

Who may be able to join

Subjects 18 and older
Subjects must be able to read and understand English
Participants must sign the informed consent form

Who cannot join

Any subjects not meeting the above inclusion criteria will not be considered for this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Real-Time Head Position Stabilization of Healthy Volunteers

Read the detailed description

This study aims to passively monitor the real-time head motions of healthy volunteers positioned to simulate whole brain radiation therapy. Such real-time head motion data is necessary in order to understand the type (amplitude/frequency) of motion that the robotic stage will be expected to compensate for and will play an important role in the overall modeling and designing process of the robotic prototype.

Conditions: Healthy
Being tested: Real-time head stabilization with robotic platform

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Real-time head stabilization with robotic platformDevice
A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive.

Study groups in NCT07116759
Study group	Role	What they receive
Healthy Volunteers		The volunteer population will consist of healthy individuals. Receives: Device: Real-time head stabilization with robotic platform

What is being measured

The primary outcome is the main question the study is designed to answer.

Collection of Head Motion Data to be Used in Developing Head Stabilization Methods in Brain Radiation Patients
Real-time intracranial target motion was continuously monitored using a commercial surface-guided radiation therapy (SGRT) system operating at approximately 10 frames per second. For each participant, translational (mm) and rotational (degree) motion of the target were computed relative to the starting head position at setup. The target position was tracked in six degrees of freedom (longitudinal, lateral, vertical translation; pitch, roll, yaw rotation). To provide a quantitative endpoint reflecting system effectiveness, the recorded 6D target motion data were analyzed and positional deviation histograms showing the total percentage of time that the target remained below a specific translational and rotational tolerance level were generated. The percentage of time that the target remained below a tolerance of < 1.0 mm translational and < 1.0° rotational deviation was chosen as the single primary outcome measure.
Measured: One-time session, up to 4 hours on a single day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 202231 Dec 2025

First posted12 Aug 2025
Study start9 Oct 2022
Primary completion1 Oct 2024
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07116759
Sponsor's protocol ID: UPCC 07325
Other IDs: R01CA227124-02, 843058
Status last verified: Jan 2026
First submitted: 7 Aug 2025
Last updated: 9 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real-Time Head Position Stabilization of Healthy Volunteers
ClinicalTrials.gov ID: NCT07116759
Acronym / sponsor ID: UPCC 07325
Conditions: Healthy
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Abramson Cancer Center at Penn MedicineUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 9 Oct 2022 (actual)
Primary completion: 1 Oct 2024 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 12 Aug 2025 (actual)
Results: Posted 19 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Healthy Volunteers	–	Device: Real-time head stabilization with robotic platformThe volunteer population will consist of healthy individuals.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: The volunteer population will consist of healthy individuals.

Key inclusion criteria (3 listed)

Subjects 18 and older
Subjects must be able to read and understand English
Participants must sign the informed consent form

Key exclusion criteria (1 listed)

Any subjects not meeting the above inclusion criteria will not be considered for this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Real-time head stabilization with robotic platformA robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive.	Device	Healthy Volunteers

Primary outcome

Collection of Head Motion Data to be Used in Developing Head Stabilization Methods in Brain Radiation Patients
Time frame: One-time session, up to 4 hours on a single day.
Real-time intracranial target motion was continuously monitored using a commercial surface-guided radiation therapy (SGRT) system operating at approximately 10 frames per second. For each participant, translational (mm) and rotational (degree) motion of the target were computed relative to the starting head position at setup. The target position was tracked in six degrees of freedom (longitudinal, lateral, vertical translation; pitch, roll, yaw rotation). To provide a quantitative endpoint reflecting system effectiveness, the recorded 6D target motion data were analyzed and positional deviation histograms showing the total percentage of time that the target remained below a specific translational and rotational tolerance level were generated. The percentage of time that the target remained below a tolerance of < 1.0 mm translational and < 1.0° rotational deviation was chosen as the single primary outcome measure.

Results and safety

Results posted to the registry on 19 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Volunteers	20	18

Primary outcome: Collection of Head Motion Data to be Used in Developing Head Stabilization Methods in Brain Radiation Patients

Time frame: One-time session, up to 4 hours on a single day.. Mean (95% Confidence Interval). Unit: % of time within tolerance

Measure	Healthy Volunteers n = 18
Value	95 (80 to 100)

Population analysed: 18 healthy volunteers, who successfully completed simulating in a clinical environment but without delivering radiation

Adverse events

Time frame: 1 year and 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Volunteers	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rodney Wiersma, PhD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Collection of Head Motion Data to be Used in Developing Head Stabilization Methods in Brain Radiation Patients (time frame: One-time session, up to 4 hours on a single day.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07116759.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.