Cryotherapy EffectPhase 1NCT03185507
The Effect of Cryotherapy on Cerebral Hemodynamics Within Healthy Subjects
A Phase 1 study testing CryoHelmet in people with Cryotherapy Effect and Oxygen Deficiency, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy Effect, Oxygen Deficiency
- What is being tested?
- CryoHelmet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2017to 13 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 25 years of age
- Recreationally active (exercise at least 30 minutes, 3 times weekly)
Who cannot join
- 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
Show all 10Show fewer
- Any known metabolism diseases
- Any known hematological diseases
- Any recreational drug use in past month
- Any known cardiopulmonary impairments or pathologies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Memorial Gymnasium
Charlottesville, Virginia, 22904
About this study
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.
Read the 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
- Being tested
- CryoHelmet
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoHelmetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Participants received superficial cryotherapy using the Cryohelmet(TM) Receives: Device: CryoHelmet |
| Control | No intervention | Participants sat quietly for 20 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenated blood
Oxygenated blood based on functional near-infrared spectroscopy (fNIRS) data output
Measured: Oxygenated blood was collected throughout the data collection period (45 minutes)
Deoxygenated blood
Deoxygenated blood based on functional near-infrared spectroscopy (fNIRS)
Measured: Dexoygenated blood was collected throughout the data collection period (45 minutes)
Stroop Task reaction time
Reaction time measured in milliseconds while completing the Stroop Task
Measured: Stroop Task reaction time was collected prior to and following the intervention. Each test took approximately 5 minutes to complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start22 Mar 2017
- Primary completion1 May 2017
- Study completion13 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Resch, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185507
- Sponsor's protocol ID
- 19706
- Status last verified
- Aug 2018
- First submitted
- 9 Jun 2017
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28123796
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cryotherapy on Cerebral Hemodynamics Within Healthy Subjects
- ClinicalTrials.gov ID
- NCT03185507
- Acronym / sponsor ID
- 19706
- Conditions
- Cryotherapy Effect, Oxygen Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Device: CryoHelmetParticipants received superficial cryotherapy using the Cryohelmet(TM) |
| Control | No intervention | –Participants sat quietly for 20 minutes |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between 18 and 25 years of age
- Recreationally active (exercise at least 30 minutes, 3 times weekly)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoHelmetCryotherapy 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. | Device | Cryotherapy |
Primary outcome
Oxygenated blood
Time frame: Oxygenated blood was collected throughout the data collection period (45 minutes)
Oxygenated blood based on functional near-infrared spectroscopy (fNIRS) data output
Deoxygenated blood
Time frame: Dexoygenated blood was collected throughout the data collection period (45 minutes)
Deoxygenated blood based on functional near-infrared spectroscopy (fNIRS)
Stroop Task reaction time
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Background: PubMed 28123796Jackson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CryoHelmet in people with Cryotherapy Effect and Oxygen Deficiency, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenated blood (time frame: Oxygenated blood was collected throughout the data collection period (45 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.