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The Effect of Cryotherapy on Cerebral Hemodynamics Within Healthy Subjects

Primary Purpose

Cryotherapy Effect, Oxygen Deficiency

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CryoHelmet
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cryotherapy Effect

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Virginia Memorial Gymnasium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cryotherapy

Control

Arm Description

Participants received superficial cryotherapy using the Cryohelmet(TM)

Participants sat quietly for 20 minutes

Outcomes

Primary Outcome Measures

Oxygenated blood
Oxygenated blood based on functional near-infrared spectroscopy (fNIRS) data output
Deoxygenated blood
Deoxygenated blood based on functional near-infrared spectroscopy (fNIRS)
Stroop Task reaction time
Reaction time measured in milliseconds while completing the Stroop Task

Secondary Outcome Measures

Full Information

First Posted
June 9, 2017
Last Updated
August 1, 2018
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT03185507
Brief Title
The Effect of Cryotherapy on Cerebral Hemodynamics Within Healthy Subjects
Official Title
The Effect of Cryotherapy on Cerebral Hemodynamics Within Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
March 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryotherapy Effect, Oxygen Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Thirty-four healthy participants were recruited from a large urban university. Participants were included if they were healthy and between the age of 18 and 25 years old. After obtaining consent, participants completed symptom, mood and medical history inventories. After determining if a participant met inclusion criteria, the subject remained seated at a testing station for a 10-minute rest period prior to NIRS data collection. Randomization was performed a priori using a random number generator and was stratified on sex. Participants either received superficial cryotherapy or sat quietly for 20 minutes.
Masking
Investigator
Masking Description
The was a randomized single-blind study. Only the clinician was blinded to which intervention was administered to each randomly assigned participant.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryotherapy
Arm Type
Experimental
Arm Description
Participants received superficial cryotherapy using the Cryohelmet(TM)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants sat quietly for 20 minutes
Intervention Type
Device
Intervention Name(s)
CryoHelmet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxygenated blood
Description
Oxygenated blood based on functional near-infrared spectroscopy (fNIRS) data output
Time Frame
Oxygenated blood was collected throughout the data collection period (45 minutes)
Title
Deoxygenated blood
Description
Deoxygenated blood based on functional near-infrared spectroscopy (fNIRS)
Time Frame
Dexoygenated blood was collected throughout the data collection period (45 minutes)
Title
Stroop Task reaction time
Description
Reaction time measured in milliseconds while completing the Stroop Task
Time Frame
Stroop Task reaction time was collected prior to and following the intervention. Each test took approximately 5 minutes to complete.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Virginia Memorial Gymnasium
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28123796
Citation
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.
Results Reference
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The Effect of Cryotherapy on Cerebral Hemodynamics Within Healthy Subjects

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