Head Stabilization of Healthy Volunteers

NCT07116759 | Completed Results FDA Device

• 3 other identifiers: UPCC 07325R01CA227124-02843058
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 patients.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  One-time session, up to 4 hours on a single day.

Study Arms (1)

Healthy Volunteers

The volunteer population will consist of healthy individuals.

Device: Real-time head stabilization with robotic platform

Interventions

Real-time head stabilization with robotic platform DEVICE

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

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The volunteer population will consist of healthy individuals.

You may qualify if:

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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Results Point of Contact

• Title: Rodney Wiersma, PhD
• Organization: University of Pennsylvania

Rodney.Wiersma@pennmedicine.upenn.edu

773-623-9820

Study Officials

• Rodney Wiersma, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 12, 2025
• Study Start: October 9, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 31, 2025
• Last Updated: February 9, 2026
• Results First Posted: December 19, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)