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Clinical Trials/EUCTR2013-004244-37-GB
EUCTR2013-004244-37-GB
Active, not recruiting
Phase 1

The control of brain networks after traumatic brain injury: a neuroimaging and neuropsychological study of dopamine and cognition - Dopamine dysregulation following TBI

Imperial College London | Imperial College NHS Healthcare Trust0 sitesDecember 30, 2013

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Imperial College London | Imperial College NHS Healthcare Trust
Status
Active, not recruiting
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 30, 2013
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Imperial College London | Imperial College NHS Healthcare Trust

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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