- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03185507
The Effect of Cryotherapy on Cerebral Hemodynamics Within Healthy Subjects
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
Virginia
-
Charlottesville, Virginia, États-Unis, 22904
- University of Virginia Memorial Gymnasium
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Cryotherapy
Participants received superficial cryotherapy using the Cryohelmet(TM)
|
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.
|
Aucune intervention: Control
Participants sat quietly for 20 minutes
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Oxygenated blood
Délai: Oxygenated blood was collected throughout the data collection period (45 minutes)
|
Oxygenated blood based on functional near-infrared spectroscopy (fNIRS) data output
|
Oxygenated blood was collected throughout the data collection period (45 minutes)
|
Deoxygenated blood
Délai: Dexoygenated blood was collected throughout the data collection period (45 minutes)
|
Deoxygenated blood based on functional near-infrared spectroscopy (fNIRS)
|
Dexoygenated blood was collected throughout the data collection period (45 minutes)
|
Stroop Task reaction time
Délai: Stroop Task reaction time was collected prior to and following the intervention. Each test took approximately 5 minutes to complete.
|
Reaction time measured in milliseconds while completing the Stroop Task
|
Stroop Task reaction time was collected prior to and following the intervention. Each test took approximately 5 minutes to complete.
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 19706
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .