The Relationship Between Traumatic Brain Injury and Dopamine (a Chemical in the Brain)
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|ClinicalTrials.gov Identifier: NCT02015949|
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : January 10, 2017
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 well-being, and can lead to significant economic and social consequences. Roughly a quarter of TBI patients improve but an equal number deteriorate over time. The investigators know little about why patients vary so much in how they recover. Crucially, the investigators 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. The investigators know that dopamine (a chemical in the brain) is known to influence many brain functions and the investigators know that pathways in the brain that use dopamine are affected by TBI.
In humans, drugs that increase dopamine in the brain, such as methylphenidate, 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 centre study, the investigators will use SPECT (Single Photon Emission Tomography) imaging to measure dopamine levels in the brain. MRI (Magnetic Resonance Imaging) scans will assess brain structure and function. The investigators will test whether treatment with methylphenidate improves cognitive functions in TBI patients who have ongoing cognitive problems, whether the mechanism involves a normalisation of brain functioning and whether brain dopamine levels can predict the magnitude of any improvement in symptoms.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Drug: Methylphenidate Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Control of Brain Networks After Traumatic Brain Injury: a Neuroimaging and Neuropsychological Study of Dopamine and Cognition|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||January 2017|
Active Comparator: Methylphenidate
2 weeks of 0.3mg/kg twice daily of methylphenidate to the nearest 5mg
Cross-over design comparing methylphenidate 0.3 mg/kg (to nearest 5mg) twice daily to placebo
Placebo Comparator: Sugar pill
2 weeks of twice daily placebo
Twice daily placebo tablet for two weeks
- The change in Choice Reaction Time task with methylphenidate treatment in patients and its relationship to specific binding ratio (SBR) of the dopamine transporter (DAT) in the striatum. [ Time Frame: On completion of the four week drug trial phase ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015949
|London, United Kingdom|
|Principal Investigator:||David J Sharp||Imperial College London|