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Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)

Baylor Scott and White Health (BSWH) logo

Baylor Scott and White Health (BSWH)

Status

Completed

Conditions

Traumatic Brain Injury

Study type

Observational

Funder types

Other

Identifiers

NCT01850290
H133A120098 (Other Grant/Funding Number)
012-277

Details and patient eligibility

About

This study will examine resting dopamine function as well as dopamine response in the brain as it interacts with medicines normally prescribed to subacute Traumatic Brain Injury (TBI) patients.

Enrollment

18 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Non-penetrating TBI
  • Age between 18-50 years old
  • Admitted to a North Texas TBI Model Systems-affiliated rehabilitation facility within 16 weeks of injury
  • Rated at Rancho VI Los Amigos Levels of Cognitive Functioning Scale of less than or equal to Stage V at the time of enrollment
  • Disability Rating Scale total score >/= 7

Exclusion criteria

  • Central Nervous System disorder resulting in functional disability predating TBI
  • Documented diagnosis of disease processes impacted by the dopamine system (e.g., Parkinson's Disease, clinician diagnosed Attention Deficit Hyperactivity Disorder, substance abuse/dependence (excluding marijuana, alcohol, tobacco), or schizophrenia)
  • Pre-injury use of dopaminergic pharmaceuticals (i.e., methylphenidate, amantadine, or dopamine receptor blockers such as olanzapine or quetiapine)
  • Documented contraindication to use of methylphenidate including allergy
  • Uncontrolled epilepsy
  • Pregnant
  • Medical condition not compatible with use of Methylphenidate
  • Recent diagnosis or therapeutic study using radiopharmaceuticals
  • Contraindications to the use of Ioflupane
  • Allergic to Iodine

Trial design

18 participants in 1 patient group

Dopamine Imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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