The primary objective is to determine whether neuroinflammation is present in subjects who have been exposed to chronic repetitive head injury during Muay Thai boxing, using [11C]-PK11195 PET.
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
The primary study parameter is the [11C]-PK11195 binding potential in the
brain.
Secondary outcome
The secondary study parameters are the degree of cognitive deficits, white
matter integrity, perfusion deficits and serum proteins indicative of
inflammation.
Background summary
Muay Thai boxing is a widely practiced and popular sport in the Netherlands.
The injuries sustained during the acute phase, including mild traumatic brain
injury, may eventually lead to a neurodegenerative disorder, chronic traumatic
encephalopathy (CTE). Current recommendations to prevent harmful consequences
in boxers in The Netherlands include physical and internal medicinal check-up,
neurologic evaluation, neuropsychological testing, MRI of the brain and EEG. It
can be argued whether these tests are adequate for evaluation. Both clinical
symptoms (e.g. cognitive and mental impairment) and typical findings on CT and
MRI (e.g. brain atrophy and hyperintensity associated with periventricular
white matter disease) often arise when the fighter has ended his career.
In traumatic brain injury, neuroinflammation is thought to play an important
role. This neuroinflammatory process is characterized by the activation of
microglia and can be beneficial when, for example, pathogens are eliminated
from the brain or in the case of stroke. However, in case of neurodegenerative
diseases microglia activation becomes chronic with a deleterious effect on the
brain and thus functioning of patients. Regarding the development of chronic
traumatic brain injury in Thai boxers, it can be hypothesized that the
repetitive blows to the head result in some brain damage, followed by
activation of microglia. The development of symptoms, such as cognitive
impairment, might be related with chronic activation of microglia.
Neuroinflammation can be imaged with the PET tracer [11C]-PK11195, which is a
ligand of the translocator protein (TSPO, formerly know as the peripheral
benzodiazepine receptor). This study aims to identify whether neuroinflammation
is present as a consequence of chronic repetitive head injury in Muay Thai
boxers using PET imaging with [11C]-PK11195.
Study objective
The primary objective is to determine whether neuroinflammation is present in
subjects who have been exposed to chronic repetitive head injury during Muay
Thai boxing, using [11C]-PK11195 PET.
Study design
Observational, cross-sectional study during a period of 1 year.
Study burden and risks
The subjects have to fill in a questionnaire and undergo neuropsychological
tests, a MRI scan and a PET scan. A total of 175 ml of blood will be taken for
determination of serum markers of inflammation and for PET scan data-analysis.
For the PET scan, the arterial catheterization can cause discomfort and the
subjects are exposed to radioactivity with minor to moderate risk. The
participants will not obtain direct benefit from the study but, if positive
results are obtained, it may lead to new therapies and diagnosis techniques in
boxers at risk of developing chronic brain injury.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
All subjects:
-Age above 18 and below 50 years
-Male sex
-Written informed consent for participation;Boxers only:
-Minimum amount of 20 competitive bouts in Muay Thai boxing with rank A or B
-Minimum amount of 3 training sessions per week
Exclusion criteria
All subjects:
-The use of benzodiazepines.
-The use of anticoagulants or having coagulation disorder.
-Use of somatic medication that may affect the immune system.
-Use of any investigational drug.
-Current or recent (<1 year) alcohol or substance abuse.
-Current or recent (<4 weeks) infectious or inflammatory disease.
-Current systemic disease.
-Major metabolic disease.
-Somatic, organic or neurological disorder (other than mTBI for patients).
-Participation in a scientific research study (<1 year) involving radiation.
-Claustrophobia.
-Presence of materials in the body that can be magnetized.
-Sustained (mild) traumatic brain injury within last 3 months.;For healthy volunteers only:
-Presence of infection of inflammation.
-(History of) Participation in contact sports, such as boxing, Muay Thai boxing, rugby, American football, etc.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2012-004785-18-NL |
CCMO | NL42384.042.12 |