The Relationship Between Traumatic Brain Injury and Dopamine (a Chemical in the Brain)

Phase 1

• Conditions: Traumatic Brain Injury; MedDRA version: 16.1Level: LLTClassification code 10060690Term: Traumatic brain injurySystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2013-004244-37-GB
• Lead Sponsor: Imperial College London | Imperial College NHS Healthcare Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-30
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria (TBI patients):
•a diagnosis of traumatic brain injury (TBI) at least 3 months prior to recruitment into the study
•age between 20 and 65 years
•right-handed
•capable of giving written informed consent
•the presence of cognitive impairment as assessed on tests of information processing speed, working memory and attention tasks

Inclusion criteria (controls):
•age between 20 and 65 years and in good general health (defined as no clinically relevant abnormalities identified on detailed medical history, physical examination, including blood pressure and pulse rate, and clinical laboratory tests)
•right-handed
•capable of giving written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

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 pre-MRI 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified