Trial Outcomes & Findings for Head Stabilization of Healthy Volunteers (NCT NCT07116759)

NCT ID: NCT07116759

Last Updated: 2025-12-19

Results Overview

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.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Target enrollment: 20 participants
• Primary outcome timeframe: One-time session, up to 4 hours on a single day.
• Results posted on: 2025-12-19

Participant Flow

Participant milestones

Measure	Healthy Volunteers The volunteer population will consist of healthy individuals. Real-time head stabilization with robotic platform: A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive.
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Healthy Volunteers The volunteer population will consist of healthy individuals. Real-time head stabilization with robotic platform: A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive.
Overall Study Incompatibility with the RHMC device	2

Baseline Characteristics

Head Stabilization of Healthy Volunteers

Baseline characteristics by cohort

Measure	Healthy Volunteers n=20 Participants The volunteer population will consist of healthy individuals. Real-time head stabilization with robotic platform: A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive.
Age, Categorical <=18 years	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants
Sex: Female, Male Female	5 Participants n=8 Participants
Sex: Female, Male Male	15 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants
Race (NIH/OMB) Asian	10 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=8 Participants
Race (NIH/OMB) White	8 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=8 Participants
Region of Enrollment United States	20 participants n=8 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Measure	Healthy Volunteers n=18 Participants The volunteer population will consist of healthy individuals. Real-time head stabilization with robotic platform: A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive.
Collection of Head Motion Data to be Used in Developing Head Stabilization Methods in Brain Radiation Patients	95 % of time within tolerance Interval 80.0 to 100.0

Adverse Events

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rodney Wiersma, PhD

University of Pennsylvania

Phone: 773-623-9820

Email: Rodney.Wiersma@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place