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Could growth hormone boost quality of life for brain-injured veterans?

NCT ID NCT04867317

Symptom relief Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This study looks at whether daily growth hormone shots for 6 months can improve quality of life in veterans who have both mild traumatic brain injury and adult growth hormone deficiency. About 172 veterans aged 21-55 will receive either the hormone or a placebo. The main goal is to see if the treatment helps them feel better day-to-day.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 172 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. OEF/OIF/OND Veteran 2. Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2) 3. Age 21 - 55 years old 4. One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey. 5. GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L), or glucagon stimulation test (cut point: 3 mcg/L for BMI up to 25; cut point 1 mcg/L for BMI 25 and above) and IGF-I lab values have to be less than or equal to +1 SDS at baseline 6. Score of 11 or more on QoL-AGHDA 7. 4-week stability on any psychotropic medications 8. 3-month stability on all other hormone treatments 9. Able and willing to provide informed consent to participate in this study, and complete study protocol. Exclusion Criteria: 1. History of moderate or severe TBI 2. History of neurologic disorder other than TBI with substantial impact on quality of life 3. History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder 4. Active suicidal ideation (no plan required) as determined by a score of 2 points or more on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation rating, or overt suicidal behavior in the past 6 months. 5. Contraindication to rhGH therapy 6. Acute medical illness, active infection, cancer or decompensated chronic medical illness 7. Evidence of substance use disorder, -other than mild alcohol or cannabis use disorder-, or urine toxicology evidence of the use of an illicit drug (excluding cannabis), in the past 6 months. Nicotine use is allowed. 8. Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory and Malingering (TOMM). 9. BMI \> 40 or body weight \> 350 lbs 10. Pituitary anatomy documented by an MRI using a sella protocol within the last 2 years indicating abnormalities consistent with an etiology other than mild-TBI (i.e.; pituitary mass) 11. Women who are pregnant or of child-bearing potential not on contraception 12. Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologic doses 13. Currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)

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Conditions

The condition(s) this trial relates to.

Brain Concussion pituitary dwarfism traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adult growth hormone deficiency Mild traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    ACTIVE_NOT_RECRUITING

    Decatur, Georgia, 30033-4004, United States

  • Birmingham VA Medical Center, Birmingham, AL

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35233-1927, United States

  • Kansas City VA Medical Center, Kansas City, MO

    NOT_YET_RECRUITING

    Kansas City, Missouri, 64128-2226, United States

  • Michael E. DeBakey VA Medical Center, Houston, TX

    RECRUITING

    Houston, Texas, 77030-4211, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    RECRUITING

    Minneapolis, Minnesota, 55417-2309, United States

  • Oklahoma City VA Medical Center, Oklahoma City, OK

    NOT_YET_RECRUITING

    Oklahoma City, Oklahoma, 73104-5007, United States

  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68105-1850, United States

  • Phoenix VA Health Care System, Phoenix, AZ

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85012, United States

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045-7211, United States

  • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

    NOT_YET_RECRUITING

    Salisbury, North Carolina, 28144, United States

  • South Texas Health Care System, San Antonio, TX

    NOT_YET_RECRUITING

    San Antonio, Texas, 78229-4404, United States

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48105-2303, United States

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    NOT_YET_RECRUITING

    Dallas, Texas, 75216-7167, United States

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    RECRUITING

    Seattle, Washington, 98108-1532, United States

  • VA San Diego Healthcare System, San Diego, CA

    NOT_YET_RECRUITING

    San Diego, California, 92161-0002, United States

  • Washington DC VA Medical Center, Washington, DC

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20422-0001, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.