We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Peter
Jenkins
p.jenkins@imperial.ac.uk
Dr
Sara
De Simoni
s.de-simoni@imperial.ac.uk
Prof
David
Sharp
david.sharp@imperial.ac.uk
Prof
David
Sharp
david.sharp@imperial.ac.uk
Injuries to the head
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
Traumatic brain injury (TBI) is the most common cause of death and disability in young adults. Patients can experience significant problems with concentration, attention, and memory (so called 'cognitive impairments') following TBI. These cognitive impairments can drastically impact on a patient's wellbeing, and can lead to significant economic and social consequences. Roughly a quarter of TBI patients improve but an equal number deteriorate over time. We know little about why patients vary so much in how they recover. Crucially, we have no treatments to improve brain functioning or recovery after TBI.
Trials investigating ways of protecting the brain just after injury have been disappointing. An alternative strategy, however, is to improve the function of brain regions that remain intact, but that function inefficiently after TBI. We know that dopamine (a chemical in the brain) is known to influence many brain functions and we know that dopamine pathways are affected by TBI.
Animal models demonstrate that TBI can produce dopamine deficiency, which can be treated by using drugs such as methylphenidate that increase dopamine levels. In humans, dopamine increasing drugs are sometimes used to enhance cognitive function after TBI, but the response to treatment can be highly variable between patients. Therefore, what is needed in the clinic is a way to target the use of these drugs to patients who are likely to respond.
In a single center study, we will use SPECT (Single Photon Emission Computed Tomography) imaging to measure dopamine levels in the brain. MRI (Magnetic Resonance Imaging) scans, will assess brain structure and function. We will test whether treatment with methylphenidate improves cognitive functions in TBI patients who have ongoing cognitive problems, whether the mechanism involves a normalization of brain functioning and whether brain dopamine levels can predict the magnitude of any improvement in symptoms.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Not Specified;
You can take part if:
You may not be able to take part if:
Exclusion criteria (TBI patients): • unwillingness or inability to follow the procedures required • significant neurological or psychiatric illness diagnosed prior to the TBI • family history of a first degree relative with a psychotic illness • currently participating in a clinical trial or has done so within 1 month before screening • use of any medication or substance that, in the opinion of the investigators, would interfere with the study or compromise participant safety • history of a drug or other allergy that, in the opinion of the investigators, contraindicates their participation in the study • history of current or past drug or alcohol addiction • female participants who are breast feeding or pregnant (positive pregnancy test) or plan to become pregnant during the study • positive urine drug screen • contraindication to MRI scanning, assessed by a standard preMRI questionnaire • contraindication to the use of methylphenidate (including medications deemed to have a potentially serious interaction with methylphenidate as per the British National Formulary) • clinical evidence of motor symptoms of Parkinsonism as assessed by a Neurologist Exclusion criteria (controls): • unwillingness or inability to follow the procedures required • significant current or previously diagnosed neurological or psychiatric illness • family history of a first degree relative with a psychotic illness • currently participating in a clinical trial or has done so within 1 month before screening • use of any medication or substance that, in the opinion of the investigators, would interfere with the study or compromise participant safety • history of a drug or other allergy that, in the opinion of the investigators, contraindicates their participation in the study • history of current or past drug or alcohol addiction • female participants who are breast feeding or pregnant (positive pregnancy test) or plan to become pregnant during the study • positive urine drug screen • contraindication to MRI scanning, assessed by a standard pre-MRI questionnaire
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
David
Sharp
david.sharp@imperial.ac.uk
Dr
Sara
De Simoni
s.de-simoni@imperial.ac.uk
Prof
David
Sharp
david.sharp@imperial.ac.uk
Dr
Peter
Jenkins
p.jenkins@imperial.ac.uk
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by Guarantors of Brain; NIHR Academy; .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 15988
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
