Real-Time Head Position Stabilization of Healthy Volunteers
Conditions: Healthy
Sponsor: Abramson Cancer Center at Penn Medicine

Head Stabilization in Volunteers 
 
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This material is the property of the University of Pennsylvania.   
 
 
REAL-TIME HEAD POSITION STABILIZATION OF HEALTHY 
VOLUNTEERS 
 
 
Principal Investigator  
Rodney Wiersma, PhD 
Department of Radiation Oncology 
University of Pennsylvania 
Perelman Center for Advanced Medicine, 2 West 
Philadelphia, PA 19104 
773-623-9820 
Rodney.Wiersma@pennmedicine.upenn.edu 
 
Funding Sponsor 
 
National Institutes of Health 
Study Product 
 
Not applicable 
 
 
IRB Number 
 
843058 
 
NIH Grant Number 
  
R01-CA227124-02 
Version 
May 18, 2020 
December 14, 2022 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
BACKGROUND AND STUDY RATIONALE ................................................................................................ 5 
1 
INTRODUCTION .................................................................................................................................. 5 
1.1 
BACKGROUND AND RELEVANT LITERATURE ..................................................................................... 5 
2 
STUDY OBJECTIVES ......................................................................................................................... 5 
2.1 
PRIMARY OBJECTIVE ...................................................................................................................... 5 
3 
INVESTIGATIONAL PLAN .................................................................................................................. 5 
3.1 
GENERAL DESIGN .......................................................................................................................... 5 
3.2 
STUDY ENDPOINTS......................................................................................................................... 6 
3.2.1 
Primary Study Endpoint ........................................................................................................... 6 
4 
STUDY POPULATION AND DURATION OF PARTICIPATION ........................................................ 6 
4.1 
DURATION OF STUDY PARTICIPATION .............................................................................................. 6 
4.2 
TOTAL NUMBER OF SUBJECTS AND SITES........................................................................................ 6 
4.3 
INCLUSION CRITERIA ...................................................................................................................... 6 
4.4 
EXCLUSION CRITERIA ..................................................................................................................... 6 
4.5 
SUBJECT RECRUITMENT ................................................................................................................. 6 
4.6 
VULNERABLE POPULATIONS ........................................................................................................... 6 
5 
STUDY PROCEDURES ....................................................................................................................... 7 
5.1 
SCREENING ................................................................................................................................... 7 
5.2 
STUDY INTERVENTION .................................................................................................................... 7 
5.3 
SUBJECT WITHDRAWAL .................................................................................................................. 7 
5.3.1 
Data Collection and Follow-up for Withdrawn Subjects .......................................................... 7 
6 
STATISTICAL PLAN ........................................................................................................................... 7 
6.1 
SAMPLE SIZE AND POWER DETERMINATION ..................................................................................... 8 
7 
SAFETY AND ADVERSE EVENTS ..................................................................................................... 8 
7.1.1 
Data and Safety Monitoring Plan............................................................................................. 8 
8 
STUDY ADMINISTRATION, DATA HANDLING AND RECORD KEEPING ...................................... 8 
8.1 
CONFIDENTIALITY ........................................................................................................................... 8 
8.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 8 
9 
STUDY MONITORING, AUDITING, AND INSPECTING .................................................................... 8 
9.1 
STUDY MONITORING PLAN .............................................................................................................. 8 
9.2 
RISKS AND BENEFITS ..................................................................................................................... 8 
9.3 
INFORMED CONSENT PROCESS / HIPAA AUTHORIZATION ................................................................ 8 
10 
STUDY FINANCES .............................................................................................................................. 9 
10.1 
FUNDING SOURCE .......................................................................................................................... 9 
10.2 
CONFLICT OF INTEREST .................................................................................................................. 9 
10.3 
SUBJECT STIPENDS OR PAYMENTS ................................................................................................. 9 
11 
PUBLICATION PLAN .......................................................................................................................... 9 
 

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Study Summary 
 
Title 
Real-Time Head Stabilization of Healthy Volunteers 
Short Title 
Head Stabilization- Volunteers 
IRB Number 
843058 
Protocol Number 
Not applicable  
Methodology 
Observational  
Study Duration 
24 months  
Study Center(s) 
Single-center 
Objectives 
• 
Development of an advanced motion control system. 
• 
Design and construction of a clinical robotic stereotactic 
radiosurgery system (SRS) using real-time 3D image tracking. 
• 
Validation of the SRS. 
Number of Subjects 
20 subjects 
Main Inclusion and 
Exclusion Criteria 
Healthy individuals will be recruited to this study.   
Intervention  
 
Head motion data collection using motion-detection cameras.   
Statistical 
Methodology 
The endpoint is purely quantitative in nature and will be determined by 
analyzing the real-time 6D target motion during the SRS procedure. 

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Data and Safety 
Monitoring Plan  
The Principal Investigator will be responsible for the data quality management 
and the ongoing safety of subjects.  
 

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Background and Study Rationale 
 
This study will be conducted in full accordance with all applicable University of Pennsylvania Research 
Policies and Procedures and all applicable Federal and state laws and regulations including as applicable 
include the following regulations as they apply 45 CFR 46, 21 CFR Parts 50, 54, 56 All episodes of 
noncompliance will be documented. 
1 
Introduction 
This is a single-center observational study in which we aim to collect real-time head motion in healthy 
volunteers. This data is a first step in developing an advanced motion control system for head 
stabilization in patients undergoing whole brain radiation therapy.  
1.1 
Background and Relevant Literature  
Stereotactic radiosurgery (SRS) is a therapy modality used for the treatment of brain disorders with 
precise radiation dose placement[1], [2]. To achieve the 1-2 mm precision for intracranial SRS, a metal 
head ring is rigidly fixated to the patient’s skull using screws under local anesthesia, and then bolted on 
the treatment couch [3]. The discomfort, inconvenience, and invasive nature associated with the frame 
preparation have been identified as the main cause of poor patient compliance and poor clinical 
efficiencies when SRS is medically indicated[4]. For certain patients, with extreme cranial anatomy or 
prior surgical bone flaps, ring placement is not possible. In addition, the frame prohibits cases when a 
hypo-fractionated scheduled is desired leading to the use of techniques with far less accuracy. For clinics, 
with tight patient LINAC scheduling, or high patient to LINAC volumes, frame based SRS scheduling can 
prove to be problematic due to the necessity of performing the CT scan, planning, setup, and treatment 
on the same day. Recent research, aimed at eliminating the ring placement, has so far resulted in 
implementations of frameless SRS with less accuracy than frame based SRS[5], [6]. Removal of the head 
ring allows room for small intrinsic head motions to occur. No radiotherapy delivery device has yet been 
developed to correct for such deviations. 
2 
Study Objectives 
The goal of our research is to develop a next generation frameless SRS approach where such small 
intrinsic head motions are continuously cancelled/corrected throughout SRS treatment. Similar to a noise 
cancellation headset, where outside noise is sampled, shifted in phase by 180o, and then added to the 
incoming sound for cancellation, the proposed method will sample head motion using real-time 6D optical 
tracking, calculate its inverse, and add it to incoming head motion using a robotic 6DOF head stage for 
cancellation of patient head motion. This approach has the potential to be less invasive than current 
frameless SRS techniques while still achieving accuracies better or equal to traditional frame based SRS. 
2.1 
Primary Objective 
 
This particular 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. 
 
 
3 
Investigational Plan  
3.1 
General Design 
 

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The study will consist of cancelling the head motions of 20 volunteers lying in a comfortable supine 
position. The volunteer population will consist of healthy individuals including individuals associated with 
The University of Pennsylvania. 
 
The real-time head monitoring will be performed using either an optical camera 3D surface imager 
(AlignRT, VisionRT, UK) or IR marker camera (Polaris, NDI, Canada) that is either mounted to the ceiling 
or supported on a tripod. Both cameras are FDA approved medical devices that are routinely used in our 
clinic. Similar to a video camera, real-time head position monitoring by the camera will be performed 
passively and will not interfere with the volunteer.  Using the real-time head position data provided by the 
camera, a motion stage placed under the head support will slowly move in order to cancel out small 
motions in order to maintain a stationary head position. 
 
3.2 
Study Endpoints  
3.2.1 Primary Study Endpoint 
The primary endpoint is collection of head motion data to be used in developing head stabilization 
methods in brain radiation patients.   
4 
Study Population and Duration of Participation  
The volunteer population will consist of healthy individuals. Subjects will be recruited by the PI and his 
research team. We do not plan to use any internet, radio, newspaper etc. advertisements for this study. 
Subjects will undergo a one-time motion detection session. 
4.1 
Duration of Study Participation  
Subjects will be considered “on study” from consent through completion of the head stabilization session; 
there is no follow-up involved.   
4.2 
Total Number of Subjects and Sites  
This is a single-institution study for which we aim to accrue 20 subjects. 
4.3 
Inclusion Criteria 
Inclusion criteria are: 
 
• 
Subjects 18 and older 
• 
Subjects must be able to read and understand English  
• 
Participants must sign the informed consent form  
4.4 
Exclusion Criteria 
Any subjects not meeting the above inclusion criteria will not be considered for this study.  
4.5 
Subject Recruitment  
Subjects will be recruited from staff, faculty, and students of the University of Pennsylvania.  
4.6 
Vulnerable Populations 
Children, pregnant women, fetuses, neonates, or prisoners are not included in this research study. 
 

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5 
Study Procedures  
5.1 
Screening 
Subjects will be recruited by the study team via face-to-face interactions and word-of-mouth. A member of 
the study team will thoroughly explain the study to each subject, reviewing all the elements of the consent 
form with them. Subjects will have ample opportunity to review the consent form and have their questions 
answered to their satisfaction. All interactions will take place in a private consultation room within the 
Department of Radiation Oncology. We anticipate that all subjects will self-identify to the study team so 
staff, students, and faculty of the University of Pennsylvania will face no undue pressure to participate. 
Once a subject is deemed eligible, a head motion session will be scheduled at their convenience.  
  
5.2 
Study Intervention  
The AlignRT system consists of three units attached to the ceiling where one unit is located at each 
lateral side of the patient treatment table and one at the center above the foot of the table. Each unit 
contains two cameras, which take pictures at slightly different perspectives, allowing for image depth 
reconstruction (3D surface image). Analysis and comparison of these 3D surface images as taken during 
the course of treatment can allow extraction of patient motions during treatment. 
The Polaris infrared (IR) camera consists of a single unit either attached to the ceiling or mounted on a 
tripod. Each unit contains two cameras, which take pictures of IR markers attached to the volunteers 
head at slightly different perspectives, allowing for triangulation of the marker positions and thus 
determination of head position. 
As both the AlignRT and Polaris devices use optical camera monitoring, it is non-invasive and will not 
physically touch or interfere with the volunteer.  Both systems are routinely used in the clinic for assuring 
that patients are correctly positioned on the treatment table. The research proposed here does not 
deviate from the FDA approved operation of the AlignRT or Polaris in anyway. 
The volunteer head support (Freedom Pursuit Robotic Platform, CDR Systems, Canada) consists of a 
stage that can both move and rotate along the volunteers superior-inferior (SI), anterior-posterior (AP), 
and left-right (LR) directions using electric motors. The motions produced by the stage are in the 
millimeter range. 
 
The volunteer will be requested to lie down in a relaxed supine position with their head supported on top 
of the stage. The AlignRT or Polaris camera system will be initialized and made to track the real-time 
motions of the volunteer’s head.  Real-time head motion tracking will proceed for approximately 15 – 30 
minutes with either the motion compensation stage turned on or off. All volunteer head motion will be 
logged for later analysis. 
5.3 
Subject Withdrawal  
Subjects may choose to withdraw at any time with no consequence. Any withdrawals will be replaced in 
order to have 20 evaluable subjects.  
5.3.1 Data Collection and Follow-up for Withdrawn Subjects 
Subjects undergo a one-time head motion detection session, there is no follow-up once the session is 
completed or once subjects withdraw.  
6 
Statistical Plan 
The data collected will not be reviewed until the study is closed to accrual. Volunteer head motion data, 
acquired in Sec. 5, will then be imported into Matlab research software and analyzed in terms of 
quantifying several basic motion parameters such as mean and maximum positional deviation, velocity of 

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the motion, and net motion trajectory.  These results will be used to quantify the performance of the head 
positioning stage in maintaining an accurate head position. 
6.1 
Sample Size and Power Determination 
This is a pilot study to collect baseline data, sample size and power calculation is not necessary.  
 
7 
Safety and Adverse Events 
The head motion detection sessions are non-invasive and do not involve any procedures that would pose 
risk to any subject nor result in any adverse events. Adverse events are not applicable to this study and 
will not be tracked.  
7.1.1 Data and Safety Monitoring Plan 
The Principal Investigator will monitor the study for data integrity and subject safety. As this study involves 
non-invasive methods to measure head motion, we determine this study to be of minimal risk to 
participants.  
8 
Study Administration, Data Handling and Record Keeping 
8.1 
Confidentiality 
All research personnel will be trained to maintain confidentiality and never to discuss study participants or 
individual research data publicly or in any private setting where they could be overheard. 
Name and date of birth will be collected from subjects only to confirm eligibility. All data collected during 
the head motion detection session will be identified only by subject number. We will not be collecting any 
PHI.  
 
8.2 
Data Collection and Management 
All research files and computer databases will be stored in secure locations within the University of 
Pennsylvania’s Department of Radiation Oncology, with access limited to members of the research team. 
These data files will be maintained for five years after the study is completed and then destroyed and/or 
erased. Data will not be shared with the study sponsor. Individual data will be reported only in the 
aggregate.  
9 
Study Monitoring, Auditing, and Inspecting 
9.1 
Study Monitoring Plan 
The study PI will be responsible for ensuring the ongoing quality and integrity of the research study.  
9.2 
Risks and Benefits 
There are no risks to volunteers as the optical camera tracking process is passive and the type of motions 
generated by the motion stage are on the order of millimeters. The data generated by this research study 
are not expected to benefit the subjects personally. The primary benefit of participation in this study would 
be to contribute to the development of improved SRS methods. The experimental data do not have any 
clinical use and will be used only for research purposes.  
9.3 
Informed Consent Process / HIPAA Authorization  
All subjects for this study will be provided a consent form describing this study providing sufficient 
information for subjects to make an informed decision about their participation in this study.  This consent 
form will be submitted with the protocol for review and approval by the IRB for the study. Potential 
subjects will review the consent form in detail with the person designated to consent (either PI or CRC) 
and have the ability to take the consent home for further review. We request waiver of documentation of 

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consent as this research is minimal risk and involves procedures for which consent is not required outside 
of the research context. Health information will not be collected, therefore, HIPAA is not applicable,  
10 Study Finances 
10.1 
Funding Source 
This study is funded through NIH grant R01-CA227124-02. 
10.2 
Conflict of Interest 
All University of Pennsylvania Investigators will follow the University of Pennsylvania Policy on Conflicts of 
Interest Related to Research.  
10.3 
Subject Stipends or Payments 
Subjects will not be compensated for participating in this study.  
11 Publication Plan 
Data acquired from the proposed studies will be analyzed and if significant will be submitted to peer 
review journals for publication. In all cases all identifying volunteer information will be removed from the 
data and the data will be completely anonymized. 
 
 
12.  References 
 
[1] 
R. D. Wiersma, Z. Wen, M. Sadinski, K. Farrey, and K. M. Yenice, “Development of a frameless 
stereotactic radiosurgery system based on real-time 6D position monitoring and adaptive head motion 
compensation,” Phys. Med. Biol., vol. 55, no. 2, pp. 389–401, Jan. 2010. 
[2] 
T. Stafinski, G. S. Jhangri, E. Yan, and D. Menon, “Effectiveness of stereotactic radiosurgery 
alone or in combination with whole brain radiotherapy compared to conventional surgery and/or whole 
brain radiotherapy for the treatment of one or more brain metastases: a systematic review and meta-
analysis,” Cancer Treat. Rev., vol. 32, no. 3, pp. 203–213, May 2006. 
[3] 
M. J. Murphy, “Intrafraction geometric uncertainties in frameless image-guided radiosurgery,” Int. 
J. Radiat. Oncol. Biol. Phys., vol. 73, no. 5, pp. 1364–1368, Apr. 2009.