Charactertizing Growth Hormone Deficiency in Traumatic Brain Injury
Characterizing Growth Hormone Deficiency in Traumatic Brain Injury: Evaluation of the Growth Hormone in Adult Quality of Life Questionnaire
The goal of this observational study is to characterize the impact of growth hormone deficiency (GHD) on quality of life, symptom burden, and sleep in adults with traumatic brain injury (TBI), and to evaluate whether these outcomes improve with growth hormone replacement therapy.
The main questions it aims to answer are:
- Does quality of life, as measured by the Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA), differ between adults with TBI and GHD compared to those with TBI and no GHD?
- Do fatigue, cognition, mood, post-concussion symptoms, body image, libido, perceived stress, and sleep architecture differ between these two groups?
- Among participants with GHD who begin growth hormone replacement therapy, do symptom burden and quality of life improve over a 12-week treatment period?
Eligible participants will be asked to complete baseline questionnaires and undergo testing for growth hormone deficiency (glucagon stimulation testing). A subset of participants will also complete objective sleep assessments using actigraphy and at-home polysomnography. For those who are diagnosed with growth hormone deficiency and choose to pursue treatment, questionnaires will be repeated bi-weekly while receiving growth hormone replacement therap
研究概览
详细说明
Growth hormone deficiency (GHD) is the most common chronic hormone deficit following traumatic brain injury (TBI) with variable prevalence (average of 10-15%), likely a reflection of the timing and methods of testing, age, and injury severity. Previous guidelines recommend assessment of GHD with serum IGF-1. However, studies have found IGF-1 lacks specificity and sensitivity and does not correlate with dynamic testing in patients with mild TBI and GHD.
The primary objective of this observational study is to determine whether the Quality of Life in Adult Growth Hormone Deficiency Assessment (QoL-AGHDA) can aid in predicting GHD in patients with mild TBI.
Patients aged 18-75 years with a diagnosis of mild TBI (American congress of rehabilitation 2023 guidelines and Centre for disease control and prevention definition of traumatic brain injury) with persistent symptoms at 1-year post-injury attending the Calgary Brain Injury program and the chronic pain centre will be screened for suspected GHD by physicians.
Eligible participants will complete the QoL-AGHDA along with other symptom based measures and will be referred to endocrinology for provocative testing for GHD (glucagon stimulation testing).
The secondary objective is to determine if the QoL-AGHDA can provide an objective measure of growth hormone treatment efficacy in patients with TBI and GHD. To address this, participants found to have GHD (peak GH of <3mcg/L following glucagon stimulation test) will be provided with growth hormone replacement (Genotropin, Pfizer) for 3 months. Participants will be asked to repeat questionnaires (QoL-AGHDA and additional symptom measures) bi-weekly throughout the 3-months of treatment.
Exploratory sleep assessment:
- Participants will be invited to participate in one or both optional sleep components of the study. All participants will be offered 6 consecutive days and nights of wrist actigraphy (MotionWatch8, CamNtech) following completion of the glucagon stimulation test or initial endocrinology appointment. The wrist-worn accelerometer will objectively measure sleep patterns, duration, and rest-activity cycles, while participants will complete a brief daily electronic sleep diary to capture subjective sleep characteristics. Participants diagnosed with GHD will be invited to repeat the actigraphy protocol and sleep diary after 3 months of growth hormone replacement therapy.
- A subset of approximately 30 participants will also complete two consecutive nights of at-home polysomnography (PSG) using the Nox SAS Solution (Nox Medical, Reykjavik, Iceland). Participants will receive written and video instructions for self-application of the device. The second night of PSG will be used for analysis to characterize objective sleep architecture and identify sleep disturbances using physiological measures including brain activity, respiratory parameters, oxygen saturation, heart rate, body position, and movement. The PSG subgroup will include approximately 10 healthy controls, 10 participants with persistent symptoms following mild TBI without GHD, and 10 participants with persistent symptoms following mild TBI and GHD. Healthy controls will complete baseline demographic and medical history forms, medication use questionnaires, and the Epworth Sleepiness Scale prior to PSG.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Chantel T Debert, MD MSc FRCPC CSCN
- 电话号码：(403) 944-4500
- 邮箱：cdebert@ucalgary.ca
研究联系人备份
- 姓名：Christina Campbell, MSc
- 电话号码：403-944-8649
- 邮箱：christina.campbel1@ucalgary.ca
学习地点
-
-
Alberta
-
Calgary、Alberta、加拿大、T2N2T9
- 尚未招聘
- Foothills Medical Center, Main Floor Special Services
-
接触：
- Chantel Debert, MD, FRCPC
- 电话号码：(403) 944-4500
- 邮箱：chantel.debert@albertahealthservices.ca
-
Calgary、Alberta、加拿大、T3G 5N2
- 招聘中
- University Of Calgary
-
接触：
- Chantel T Debert, MD MSc FRCPC
- 电话号码：403- 944-4500
- 邮箱：cdebert@ucalgary.ca
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion criteria: Adults aged 18-70 years must be referred and have a diagnosis of mTBI made by a brain injury specialist physician and meet the 2023 ACRM diagnostic criteria (Appendix A, Panel A) or the NIH diagnostic criteria for moderate/severe TBI (Appendix A, Panel B). All participants must be symptomatic for at least one-year post-injury (determined by the Glasgow Extended Scale score of less than 8 for moderate/severe TBI and a Rivermead Post-Concussion Questionnaire score of > 13 with 3 or more symptoms scored > 3 for mTBI), at the time of screening. All participants must also be fluent in English and be able to either complete questionnaires online or over the phone.
In terms of concomitant therapies and medication, all prescription and non-prescription medications (e.g., over-the-counter drugs and herbal supplements) and therapies will be recorded by participants during baseline assessments. Participants with GHD on treatment will be asked to disclose any changes in medications/and or therapies at each bi-weekly follow up questionnaires.
Exclusion criteria include untreated pituitary deficits to minimize confounding factors (unless treated/consulted with Dr. Debert and/or Dr. Lithgow), other intracranial abnormalities, chronic neurological conditions, untreated medical conditions, major medical conditions in the past 6 months such as stroke, and current or planned pregnancy.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Suspected Growth Hormone Deficiency
Participants attending the Calgary Brain Injury Program or Chronic Pain Centre with persistent post-concussion symptoms for over 1 year suspected of having GHD. Participants will be asked to complete the QoL-AGHDA and additional post-concussion symptom questionnaires and referred to endocrinology for provocative testing (glucagon stimulation testing) |
不适用（观察性研究）
|
|
Growth Hormone Deficiency Treatment
Participants with GHD (peak GH of < 5 mcg/L following glucagon stimulation test (GST) will be provided with growth hormone replacement (Genotropin, starting dose 0.2 ug/L and 0.3ug/L for women taking exogenous oral estrogen, Pfizer) for 3 months. Participants will repeat the QoL-AGHDA and exploratory outcome questionnaires bi-weekly throughout treatment (3-months). |
不适用（观察性研究）
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of Life in Adult Growth Hormone Deficiency Assessment (Qol-AGHDA)
大体时间：To be completed at baseline and repeated bi-weekly during Genotropin treatment and treatment completion (3 months)
|
A 25-question, self-administered, condition specific quality of life measure used to determine the extent to which growth hormone deficiency has affected the patient's quality of life.
Participants are instructed to answer "yes" or "no" to statements relating to problems with memory and concentration, tiredness, tenseness, social isolation and self-confidence.
Higher scores indicate greater symptom burden and lower quality of life.
|
To be completed at baseline and repeated bi-weekly during Genotropin treatment and treatment completion (3 months)
|
|
Glucagon Stimulation Testing
大体时间：Baseline
|
Provocative glucagon stimulation testing completed by endocrinology.
Peak growth hormone of less than 3mcg/L indicative of growth hormone deficiency
|
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Saint Louis University Mental Status Examination (SLUMS)
大体时间：To be assessed at baseline and at completion of treatment (3 months)
|
Assesses for mild cognitive impairment.
Total possible score ranges from 0 to 30, with higher scores indicative of better outcomes.
|
To be assessed at baseline and at completion of treatment (3 months)
|
|
Fatigue and Altered Cognition Scale (FACS)
大体时间：To be repeated bi-weekly during Genotropin treatment and treatment completion (3 months)
|
A 20-item self-reported questionnaire that measures central fatigue and altered cognition, , with 10 items comprising each subscale.
Items are rated on an electronic visual analog scale (0-100), with higher scores indicating greater symptom severity.
|
To be repeated bi-weekly during Genotropin treatment and treatment completion (3 months)
|
|
Patient Health Questionnaire - 9 (PHQ-9)
大体时间：To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)
|
Assesses depressive symptoms.
Total possible score ranges from 0-27, with higher scores indicative of worse outcomes.
|
To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)
|
|
Generalized Anxiety Disorder -7 (GAD-7)
大体时间：To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)
|
Assesses feelings of anxiety.
Total possible score ranges from 0-21, with higher scores indicative of worse outcomes.
|
To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)
|
|
Rivermead Post-Concussion Symptom Questionnaire (RPQ)
大体时间：To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)
|
Assesses the severity of 16 commonly experienced PCS symptoms.
Participants are instructed to rate the extent to which they have suffered from each of the listed symptoms in the past 24 hours, as compared to pre-injury levels, using a scale of 0 ("not experienced at all") to 4 ("a severe problem").
The RPQ has been demonstrated as a valid measure of PPCS with a minimal clinically important difference (MCID) of 4.5 points.
It is advised to analyze this assessment as two separate scales (RPQ-13 and RRQ-3).
The RPQ-3 has a total possible score of 0-12, with higher scores indicative of worse outcomes.
The RPQ-13 has a total possible score of 0-52, with higher scores indicative of worse outcomes.
Using these sub-scales, the instrument has good test-retest reliability and external construct validity.
This questionnaire probes the separate cognitive, emotional and somatic components of PPCS.
|
To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)
|
|
Glasgow outcome scale extended (GOSE)
大体时间：To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)
|
Assesses outcomes following brain injury.
Scores range from 1 to 8 with higher scores meaning better outcomes.
|
To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)
|
|
Sleep and Concussion Questionnaire
大体时间：To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)
|
A self-reported 6-item questionnaire to identify and quantify changes in sleep in response to concussion and monitor these changes over time.
|
To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months)
|
|
Sexual Desire Inventory (SDI
大体时间：To be assessed at baseline, 4-weeks post-treatment starts and at completion of treatment (3 months)
|
A 14-item self-report tool that measures sexual desire, distinguishing between dyadic (with others) and solitary (by oneself) desire.
This provides insight into sexual motivation, and any changes over time.
|
To be assessed at baseline, 4-weeks post-treatment starts and at completion of treatment (3 months)
|
|
Godin Leisure-Time Questionnaire:
大体时间：To be assessed at baseline and at completion of treatment (3 months)
|
A brief self-report tool that measures frequency of mild, moderate, and strenuous physical activity during free time in a typical week, and how this has changed following injury.
|
To be assessed at baseline and at completion of treatment (3 months)
|
|
Body Image Scale (BIS):
大体时间：To be assessed at baseline, 4-weeks post-treatment starts and at completion of treatment (3 months)
|
A 10-item self-report questionnaire that assesses affective, behavioral, and cognitive aspects of body image perception.
|
To be assessed at baseline, 4-weeks post-treatment starts and at completion of treatment (3 months)
|
|
Epworth Sleepiness Scale (ESS)
大体时间：To be assessed at baseline, 4-weeks post-treatment starts and at completion of treatment (3 months)
|
An 8-item self-report questionnaire that assesses daytime sleepiness by rating the likelihood of dozing in common daily situations, producing a total score where higher values indicate greater levels of daytime sleepiness.
|
To be assessed at baseline, 4-weeks post-treatment starts and at completion of treatment (3 months)
|
|
Perceived Stress Scale (PSS)
大体时间：To be assessed at baseline, treatment start, 4-weeks post-treatment start and at completion of treatment (3 months)
|
A 10-item self-report questionnaire that evaluates the degree to which individuals perceive their lives as unpredictable, uncontrollable, and overwhelming over the past month.
Respondents rate how often they experienced specific thoughts and feelings on a 5-point Likert scale (0 = never to 4 = very often), with total scores ranging from 0 to 40, where higher scores indicate greater perceived stress.
|
To be assessed at baseline, treatment start, 4-weeks post-treatment start and at completion of treatment (3 months)
|
|
Waist Circumference:
大体时间：To be assessed at baseline and at completion of treatment (3 months)
|
Waist circumference will be measured using a flexible measuring tape placed midway between the last rib and the top of the iliac crest, with the participant standing comfortably.
The measurement will be recorded to the nearest 0.1 cm.
|
To be assessed at baseline and at completion of treatment (3 months)
|
|
Hand Grip Strength
大体时间：To be assessed at baseline and at completion of treatment (3 months)
|
Hand grip strength will be assessed using a hand grip dynamometer.
Participants will complete three trials with each hand, and the average of the three trials for each hand will be calculated and used for analysis.
|
To be assessed at baseline and at completion of treatment (3 months)
|
|
Wrist Based Actigraphy
大体时间：If participants have GHD, they will be asked to repeat the same actigraphy protocol for 6 nights/days with daily sleep diary completion at the 3-month post treatment mark.
|
At the time of the GST or initial endocrinology appointment, all participants will be asked to wear a wrist-based actigraph on their non-dominant hand (MotionWatch8, CamNtech), an accelerometer that tracks movement and activity, for six consecutive days and nights after the GST has been completed.
During each actigraphy recording period, participants will complete a brief daily digital sleep diary.
This will allow for objective measurement of sleep patterns, duration, and rest-activity cycles, which will be compared with participants' subjective perceptions of sleep recorded in the sleep diary.
|
If participants have GHD, they will be asked to repeat the same actigraphy protocol for 6 nights/days with daily sleep diary completion at the 3-month post treatment mark.
|
|
At-home polysomnography (PSG)
大体时间：Baseline
|
A subset of participants will be invited to complete a two-night at-home sleep study using a portable polysomnography device (Nox SAS Solution, Nox Medical, Reykjavik, Iceland).
The Nox device records multiple sleep-related physiological signals during sleep, including breathing patterns, oxygen saturation, heart rate, body position, and movement.
Participants will be provided with video and written instructions to guide them through the self-setup of the device and sensors prior to the recording period.
The sleep study will be completed in the participant's home over two consecutive nights.
Data collected from the Nox system will be used to characterize objective sleep patterns and identify potential sleep disturbances.
Approximately 30 participants will be recruited for this exploratory component, including: 10 healthy controls with no history of concussion or traumatic brain injury, 10 participants with persisting symptoms following mTBI without GHD, 10 participants with GHD & mTBI
|
Baseline
|
合作者和调查者
合作者
调查人员
- 首席研究员：Chantel T Debert, MD MSc FRCPC CSCN、University Of Calgary
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- REB24-0244
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.