- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03185507
The Effect of Cryotherapy on Cerebral Hemodynamics Within Healthy Subjects
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The prevalence of concussion has been estimated to be between 4,380 and 10,403 concussions per day in the United States annually with over an estimated 3 million visits to emergency departments each year.1 Symptoms following a concussion last up to 10 days for 90% of cases2; however, the reduction of symptoms in this time frame does not indicate full neurometabolic recovery.
Following concussion, a neurometabolic cascade of events immediately occurs following initial impact with return to normative values around 30 days post-injury. In an attempt to maintain homeostasis in the brain following impact, glucose and oxygen demand increases temporarily and are coupled with periods of increased hyperperfusion and decreased cerebral blood flow (CBF). Although the neurometabolic timeline immediately following impact is only generally understood, there is consensus upon acute increases in CBF and metabolic activity followed by decreased CBF until return to normative values.
Cryotherapy has been studied extensively for its' effects throughout the musculoskeletal system. Cryotherapy in the musculoskeletal system has been shown to decrease tissue temperature and blood flow, as well as decrease oxygen and energy demands.12-19 Cryotherapy has also been applied in cases of moderate or severe traumatic brain injury and has demonstrated to decrease intracranial metabolic processes and oxygenation consumption. Although the potential benefits of cryotherapy have been established in cases of moderate to severe traumatic brain injury (TBI), there is no current research examining cryotherapy in the treatment of concussion.
A convenience sample of 34 healthy, recreationally active individuals between the ages of 18-25 years will be recruited for participation in this study. The independent variable in this study will be group (cryotherapy, control). The primary outcome measures of interest are cognitive functioning measured using the Stroop Test and cerebral blood hemodynamics and hemoglobin saturation measured using near infrared spectroscopy. The pain visual analog scale (VAS) will be used to quantify tolerance to the intervention.
The following study will address the following objectives and related hypotheses:
Objective 1: To determine if the application of cryotherapy influences intracranial hemodynamics within healthy recreationally active young adults.
Hypothesis 1: Cryotherapy will cause a decrease in intracranial hemodynamics; specifically, the CO2 saturation and deoxygenated hemoglobin causing a decrease in intracranial metabolic activity.
Objective 2: To determine if the application of cryotherapy decreases cerebral blood flow within healthy recreationally active individuals.
Hypothesis 2: The application of cryotherapy will not cause a change in cerebral blood flow due to the highly regulated central nervous system.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
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Virginia
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Charlottesville, Virginia, Spojené státy, 22904
- University of Virginia Memorial Gymnasium
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Between 18 and 25 years of age
- Recreationally active (exercise at least 30 minutes, 3 times weekly)
Exclusion Criteria:
- Contraindications for cryotherapy (eg. Raynaud's phenomenon, cold urticaria)
- Any documented learning difficulty or disability
- Any known neurological or psychiatric disorder
- History of migraines
- History of a concussion or traumatic brain injury in past 6 months
- Currently taking psychotropic medications
- Any known metabolism diseases
- Any known hematological diseases
- Any recreational drug use in past month
- Any known cardiopulmonary impairments or pathologies
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Cryotherapy
Participants received superficial cryotherapy using the Cryohelmet(TM)
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Cryotherapy was administered using the Catalyst CryoHelmet™ (All-Star Sporting Goods®, Shirley, Massachusetts, USA).
The CyroHelmet is a flexible helmet equipped with gel ice packs meant to cool the head and neck.
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Žádný zásah: Control
Participants sat quietly for 20 minutes
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Oxygenated blood
Časové okno: Oxygenated blood was collected throughout the data collection period (45 minutes)
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Oxygenated blood based on functional near-infrared spectroscopy (fNIRS) data output
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Oxygenated blood was collected throughout the data collection period (45 minutes)
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Deoxygenated blood
Časové okno: Dexoygenated blood was collected throughout the data collection period (45 minutes)
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Deoxygenated blood based on functional near-infrared spectroscopy (fNIRS)
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Dexoygenated blood was collected throughout the data collection period (45 minutes)
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Stroop Task reaction time
Časové okno: Stroop Task reaction time was collected prior to and following the intervention. Each test took approximately 5 minutes to complete.
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Reaction time measured in milliseconds while completing the Stroop Task
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Stroop Task reaction time was collected prior to and following the intervention. Each test took approximately 5 minutes to complete.
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 19706
Plán pro data jednotlivých účastníků (IPD)
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