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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004244-37 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate | Active Comparator | 2 weeks of 0.3mg/kg twice daily of methylphenidate to the nearest 5mg |
|
| Sugar pill | Placebo Comparator | 2 weeks of twice daily placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | Cross-over design comparing methylphenidate 0.3 mg/kg (to nearest 5mg) twice daily to placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | On completion of the four week drug trial phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J Sharp | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College | London | London | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 21, 2021 | |
| Reset | Oct 13, 2021 | |
| Release | Jun 8, 2022 | |
| Reset | Mar 16, 2023 | |
| Release | Nov 4, 2024 | |
| Reset | Dec 12, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 21, 2021 | Oct 13, 2021 | |||
| Jun 8, 2022 |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Twice daily placebo tablet for two weeks |
|
| Mar 16, 2023 |
| Nov 4, 2024 | Dec 12, 2024 |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |