Purpose of this Study
People in this study will be placed into one of three groups based on their brain condition. During their planned brain surgery, doctors will collect a small sample of bone marrow from the skull and a small sample of blood. This will happen only one time while the patient is fully asleep under anesthesia. The sample will be taken during the surgery and should not make the operation much longer.
There is no study medicine or device. The only part of the study is the one-time sample collection. Patients can choose to stop being in the study at any time, even before or after the sample is taken.
Who Can Participate?
Eligibility
People can join this study if they are having brain surgery for certain conditions. These include a recent stroke or a recent head injury, Parkinsons disease, epilepsy, essential tremor, or Chiari malformation. People with a recent stroke or head injury must be at least 16 years old. There is no age limit for people having surgery for Chiari malformation. All other people must be at least 18 years old.
People cannot join the study if they have had Chiari surgery before, if they have another brain or nerve problem, if they have an infection in the skull bone, or if they have had radiation to the skull. They also cannot join if their immune system is weak because of conditions like HIV or AIDS, hepatitis, cancer treatment in the last five years, leukemia, lymphoma, lupus, type 1 diabetes, or if they do not have a spleen.
Age Range
0-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The goal of this study is to learn more about the bone marrow inside the skull in people who have had a recent head or brain injury and in people who have not. Researchers will compare the samples from these groups. This will help them understand how the brain calls for immune cells after an injury and where these cells come from.
Locations
Duke University Hospital
Visit Timing
Weekdays
Weekends
Evenings
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
Cranial Diploic Bone Marrow Immune Profiling in Acute and Chronic Neurosurgical Conditions: A Pilot Prospective Study
Principal Investigator
Dennis
Turner
Protocol Number
PRO00118959
Enrollment Status
Pending Open to Enrollment