- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01201863
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
July 6, 2021 updated by: Cynthia Harrison-Felix, PhD, Craig Hospital
The purpose of this study was to address 3 short term objectives; (1) Determine the effects of physiologic testosterone (T) therapy on neurological function and functional independence following traumatic brain injury (TBI) in hypogonadal men during inpatient rehabilitation; (2) Document the natural history of neuroendocrine dysfunction and recovery in men during inpatient rehabilitation after TBI; (3) Obtain data to validate the NIH toolbox, a novel assessment of neurological function for use in the TBI population; and 2 long-term objectives: (1) Utilize study findings to design a multicenter trial to further assess the impact of T therapy in hypogonadal men following TBI and (2) Impact TBI practice management with new information about neuroendocrine dysfunction after TBI and hormone treatments to improve outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This randomized, double blind, placebo-controlled pilot study assessed the hormonal status of men on admission to an inpatient TBI rehabilitation program.
498 consecutively admitted men for TBI rehabilitation were screened for participation in the study.
22 participants with low T who met all criteria were randomized into placebo (n=10), or physiologic T therapy (n=12).
Of those with normal T who met all criteria, 24 were randomized into a follow up group.
All participants were evaluated every two weeks for up to 12 weeks: hormone levels, FIM ratings and NIH Toolbox testing as able.
There was participant drop out over time as participants were discharged from the hospital.
The final analysis examined differences between the normal T, low T Treatment and low T placebo groups on hormone levels, FIM ratings and NIH Toolbox results at baseline and weeks 2, 4 and 6.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Englewood, Colorado, United States, 80113
- Craig Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- History of TBI as defined as "damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness or post traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination;"82
- Moderate to severe TBI as indicated by a Glasgow Coma Scale (GCS) score of less than or equal to 12 at emergency department admission, or post traumatic amnesia (PTA) of greater than or equal to seven days post-injury, or radiographic evidence of intracranial injury;
- Continuously hospitalized from time of injury until admission for rehabilitation;
- Enrolled in study within 6 months of TBI;
- Receiving inpatient rehabilitation for TBI at Craig Hospital;
- Males between the ages of 16 to 65 (inclusive);
- Approval by attending physician;
- Testosterone level below the assay normal range;
Consent to study participation
Exclusion Criteria:
- History of any conditions that would prohibit testing contained in the NIH toolbox;
- Non-English or non-Spanish speaking (to the extent that would limit the ability to complete study measures);
- History of prior psychiatric illness requiring hospitalization;
- Prior testosterone therapy;
- History of or current or suspected hormonally dependent cancer , including carcinoma of the breast or prostate cancer;
- Known hypersensitivity to any T gel ingredients including alcohol and soy products;
- Hematocrit (HCT) greater than 55% (normal range in Colorado is up to 52) or transaminase elevation >4x upper limit of the normal range.
- Abnormal finding on digital rectal examination such as nodule, asymmetry, or induration (Does not include enlarged prostate or abnormal rectal tone)
- PSA>4.0
- BMI <16 or >40kg/m2
- History of untreated prolactinoma
- History of severe heart failure or uncontrolled medical problem that would interfere with the participant's safety in the study as determined by the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low T Intervention - Androgel Treatment
Men with TBI meeting study criteria with Low Testosterone levels were randomly assigned to the Androgel treatment group.
They underwent hormonal assays, FIM ratings and NIH Toolbox testing at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization.
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2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g.
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Placebo Comparator: Low T Intervention - Placebo Treatment
Men with TBI meeting study criteria with Low Testosterone levels were randomly assigned to the Placebo gel treatment group.
They underwent hormonal assays, FIM ratings and NIH Toolbox testing at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization.
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2.5 gram stickpacks with starting dose of 5g increasing to max of 10g.
|
No Intervention: Normal T
A subset of men with TBI meeting study criteria with normal T at screening were assessed at all data collection time points to provide a control group.
Thirty-eight men obtained normal T levels at screening of which 24 were followed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Restricted Functional Independence Measure (FIM)
Time Frame: Administered at baseline and every other week for up to 12 weeks with 7 total possible administrations.
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The FIM is the most widely accepted functional assessment measure in use in the rehabilitation community in the US.
It is an 18-item ordinal clinician rating scale that is useful for assessment of functional skills progress during inpatient rehabilitation.
It measures levels of independent/dependent performance of 13 motor functions and 5 cognitive functions.
By adding the points for each item, the possible total score ranges from 18 to 126, with higher numbers indicating better performance.
A restricted FIM total score that eliminated the toileting, bladder management and bowel management items was computed and used in the final analysis with scores ranging from 14-105).
The restricted FIM total score was used as the primary outcome measure.
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Administered at baseline and every other week for up to 12 weeks with 7 total possible administrations.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David Ripley, MD, Rehab Institute of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
September 13, 2010
First Submitted That Met QC Criteria
September 14, 2010
First Posted (Estimate)
September 15, 2010
Study Record Updates
Last Update Posted (Actual)
July 27, 2021
Last Update Submitted That Met QC Criteria
July 6, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10 IHA 11650
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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