Traumatic Brain InjuryNCT01850290
Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)
An observational study of Traumatic Brain Injury, run by Baylor Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Traumatic Brain Injury patients in Inpatient Rehabilitation
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dopamine Imaging | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disability Rating Scale
The primary outcome measure will be the change in Disability Rating Scale over 4 weeks. The Disability Rating Scale is a commonly used and reliable instrument for monitoring minor changes occurring throughout the course of a patient's recovery (Rappaport et al., 1982).
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary outcomes (4)
John F Kennedy Coma Recovery Scale Revised
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Functional Independence Measure (FIM)
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Functional Assessment Measure (FAM)
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Orientation Log (O-Log)
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center
- Responsible party
- Sponsor
- Investigators
- Shahid Shafi, MD, Principal investigator, Baylor Research InstituteDevous Michael, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850290
- Sponsor's protocol ID
- 012-277
- Other IDs
- H133A120098
- Status last verified
- Feb 2018
- First submitted
- 7 May 2013
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT01850290
- Acronym / sponsor ID
- 012-277
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center
- Study start
- May 2013 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dopamine Imaging | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Traumatic Brain Injury patients in Inpatient Rehabilitation
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Disability Rating Scale
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
The primary outcome measure will be the change in Disability Rating Scale over 4 weeks. The Disability Rating Scale is a commonly used and reliable instrument for monitoring minor changes occurring throughout the course of a patient's recovery (Rappaport et al., 1982).
4 secondary outcomes
John F Kennedy Coma Recovery Scale Revised
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Functional Independence Measure (FIM)
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Functional Assessment Measure (FAM)
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Orientation Log (O-Log)
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahid Shafi, MD principal investigator
Baylor Research Institute
Devous Michael, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disability Rating Scale (time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.