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Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy

This study is currently recruiting participants.
Verified November 2012 by Craig Hospital
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Cynthia Harrison-Felix, PhD, Craig Hospital
ClinicalTrials.gov Identifier:
NCT01201863
First received: September 13, 2010
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is 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 two 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.


Condition Intervention Phase
Testosterone
Trauma
Brain Injury
 Drug: Androgel (Testosterone Gel)
Drug: Androgel Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Craig Hospital:

Primary Outcome Measures:
  • Functional Independence Measure (FIM) [ Time Frame: Administered at baseline and every other week for 12 weeks with 7 total administrations. ] [ Designated as safety issue: No ]
    The most widely accepted functional assessment measure in use in the rehabilitation community in the US. 18-item ordinal scale useful for assessment of progress during inpatient rehabilitation. Measures independent performance in self-care, sphincter control, transfers, locomotion, communication, and social cognition. By adding the points for each item, the possible total score ranges from 18 to 126.


Secondary Outcome Measures:
  • NIH Toolbox [ Time Frame: Administered at baseline and every other week for 12 weeks with 7 total adminsitrations ] [ Designated as safety issue: No ]
    Tool assesses 4 domains; cognition, motor, sensory and emotional.


Estimated Enrollment: 144
Study Start Date: September 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention - Treatment
Men with TBI meeting study criteria with Low Testosterone levels will be randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure.
 Drug: Androgel (Testosterone Gel)
2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g.
Other Name: Androgel (Testosterone Gel)
Placebo Comparator: Intervention Placebo
Men with TBI meeting study criteria with Low Testosterone levels will be randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure.
 Drug: Androgel Placebo
2.5 gram stickpacks with starting dose of 5g increasing to max of 10g.
Other Name: Androgel Placebo

Detailed Description:

This study will assess the hormonal status of men on admission to an inpatient TBI rehabilitation program. Eighty-eight Individuals with low Testosterone (T) levels will be randomized to receive either physiologic T therapy or placebo. Fifty-six Individuals with sufficient levels of T will be followed as a second control group. All three groups will undergo serial assessment of neurological function (as measured by the NIH Toolbox) and functional independence (FIM) to correlate with hormone levels. Hormone levels will be assessed through analysis of blood samples drawn from all participants at the time of study screening and at two week intervals for a total of 7 blood draws during the 12 week study period. Demographics, injury characteristics, concomitant medication usage and adverse events will be documented by medical record review. Statistical analysis will be performed to test study hypotheses. Findings will be disseminated at professional and consumer conferences and in peer-reviewed journals and consumer-based publications. Results will also be made available through the Craig Hospital website and via summary report to the Colorado TBI Trust Fund Research Program. If T therapy is found to be effective, findings will be used as preliminary data for a grant proposal for a multi-center trial.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. 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;
  3. Continuously hospitalized from time of injury until admission for rehabilitation;
  4. Enrolled in study within 6 months of TBI;
  5. Receiving inpatient rehabilitation for TBI at Craig Hospital;
  6. Males between the ages of 16 to 65 (inclusive);
  7. Approval by attending physician;
  8. Testosterone level below the assay normal range;

  9. Consent to study participation

    Exclusion Criteria:

  10. History of any conditions that would prohibit testing contained in the NIH toolbox;
  11. Non-English or non-Spanish speaking (to the extent that would limit the ability to complete study measures);
  12. History of prior psychiatric illness requiring hospitalization;
  13. Prior testosterone therapy;
  14. History of or current or suspected hormonally dependent cancer , including carcinoma of the breast or prostate cancer;
  15. Known hypersensitivity to any T gel ingredients including alcohol and soy products;
  16. Hematocrit (HCT) greater than 55% (normal range in Colorado is up to 52) or transaminase elevation >4x upper limit of the normal range.
  17. Abnormal finding on digital rectal examination such as nodule, asymmetry, or induration (Does not include enlarged prostate or abnormal rectal tone)
  18. PSA>4.0
  19. BMI <16 or >40kg/m2
  20. History of untreated prolactinoma
  21. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201863

Contacts
Contact: Melissa Sendroy-Terrill, MS 303-789-8307 msendroy@craighospital.org

Locations
United States, Colorado
Craig Hospital Recruiting
Englewood, Colorado, United States, 80113
Principal Investigator: Alan Weintraub, MD            
Sponsors and Collaborators
Craig Hospital
University of Colorado, Denver
Investigators
Principal Investigator: David Ripley, MD Rehab Institute of Chicago
  More Information

No publications provided

Responsible Party: Cynthia Harrison-Felix, PhD, Assistant Director of Research, Craig Hospital
ClinicalTrials.gov Identifier: NCT01201863     History of Changes
Other Study ID Numbers: 10 IHA 11650
Study First Received: September 13, 2010
Last Updated: November 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Craig Hospital:
Testosterone
Traumatic Brain Injury
Hypogonadism
Endocrine Dysfunction
Low Testosterone in men with new Traumatic Brain Injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
 Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on June 18, 2013