The Effect of Cryotherapy on Cerebral Hemodynamics Within Healthy Subjects

NCT ID: NCT03185507

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-22
• Study Completion Date: 2018-03-13

Brief Summary

Upon suffering a concussion, a neurometabolic cascade including an increase in glucose and oxygen demand occurs for up to 48 hours post-insult.5 This period of increased glucose and oxygen demand is coupled with a period of hyperperfusion and decreased cerebral blood flow. 6-9 Cryotherapy in the musculoskeletal system has been shown to decrease tissue temperature, blood flow, oxygen and metabolic demands.10-17 Cryotherapy following moderate or severe traumatic brain injury has been demonstrated to decrease intracranial metabolic processes and oxygenation consumption.18-23 Although the benefits of cryotherapy have been established in moderate-severe TBI, the effects of superficial cranial cooling in individuals with and without concussion are unknown. The purpose of this randomized control trial is to evaluate the effects of superficial cryotherapy on cerebral blood flow and cognitive function in healthy, recreationally active young adults.

Detailed Description

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.

Conditions

Cryotherapy Effect; Oxygen Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cryotherapy

Participants received superficial cryotherapy using the Cryohelmet(TM)

Group Type: EXPERIMENTAL

CryoHelmet

Intervention Type: DEVICE

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.

Control

Participants sat quietly for 20 minutes

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CryoHelmet

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Jacob Resch

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Virginia Memorial Gymnasium

Charlottesville, Virginia, United States

Countries

United States

References

Jackson K, Rubin R, Van Hoeck N, Hauert T, Lana V, Wang H. The effect of selective head-neck cooling on physiological and cognitive functions in healthy volunteers. Transl Neurosci. 2015 Jun 26;6(1):131-138. doi: 10.1515/tnsci-2015-0012. eCollection 2015.

Reference Type: BACKGROUND

PMID: 28123796 (View on PubMed)

Other Identifiers

19706

Identifier Type: -

Identifier Source: org_study_id