HealthyCRYONCT07381920
Effects of Muscle Cooling on Motor Unit Firing of the Quadriceps
A study testing Cryotherapy in people with Healthy, run by Wake Forest University at 1 site in United States.
Trial summary
The overall objective of this pilot study is to establish the feasibility and methodological validity of using high-density surface electromyography to characterize motor unit behavior of the quadriceps under thermoneutral and locally cooled conditions, and to generate preliminary data to inform the design of a… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cryotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2026to May 2027
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women between the ages of 18 and 35 years
- Healthy adults, defined as absence of significant acute/chronic medical condition, injury, and/or illness that may compromise subject safety, limit the ability of the participant to complete the study, and/or compromise the objectives of the study as determined by the Principal Investigator.
Who cannot join
- Current diagnosis or history of:
- major metabolic disease (e.g., type I and type II diabetes),
- neuromuscular disease (e.g., cervical spondylotic radiculomyelopathy, lumbar spondylosis, amyotrophic lateral sclerosis, Guillain-Barré syndrome, and acquired demyelinating polyneuropathies),
- cardiovascular disease (e.g., stage II hypertension, heart failure, myocardial infarction/ischemia, peripheral vascular disease, Raynaud's phenomenon, or other conditions associated with impaired peripheral circulation),
- significant myocardial or pericardial diseases (e.g. amyloidosis, constriction),
- moderate or severe valvular disease,
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- pulmonary/respiratory disease (e.g., asthma, chronic bronchitis, emphysema, chronic obstructive pulmonary disease),
- cancer,
- renal disease,
- liver disease,
- or anemia.
- Current or recent musculoskeletal injury (e.g. fracture, sprain, dislocation) or any physical disability that precludes safe and adequate testing.
- Pregnancy or breastfeeding.
- Thigh circumference greater than 23 inches
- Mid-thigh skinfold thickness greater 40 mm
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health and Exercise Science at Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
Official title: Effects of Muscle Cooling on Motor Unit Firing of the Quadriceps: A Pilot Feasibility Study
The overall objective of this pilot study is to establish the feasibility and methodological validity of using high-density surface electromyography to characterize motor unit behavior of the quadriceps under thermoneutral and locally cooled conditions, and to generate preliminary data to inform the design of a larger, hypothesis-driven study.
Read the detailed description
This randomized, cross-over pilot study will recruit 24 healthy young adults (12 men and 12 women) between the ages of 18 and 35 years. Participants will attend two in-person laboratory visits separated by a minimum of 48 hours. Visit 1 will include informed consent, eligibility confirmation, baseline assessments, and familiarization procedures. Visit 2 will include experimental testing under thermoneutral and cooled conditions.
- Conditions
- Healthy
- Being tested
- Cryotherapy
- Keywords
- muscle cooling, motor unit behavior, HDsEMG, Quadriceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
For the cold condition, an Aircast Thigh Pad (Aircast), connected to the Cryo Cuff IC cooler (DJO Global, Vista, California, USA) will be applied to the dominant thigh. The system circulates ice water maintained at approximately 10-15°C with intermittent compression. Cooling duration will be individualized based on mid-thigh skinfold thickness, consistent with published recommendations that account for the effect of subcutaneous tissue on intramuscular cooling9. Participants with a mid-thigh skinfold thickness of 0-10 mm will receive 10 minutes of cooling; those with a skinfold thickness of 11-20 mm will receive 25 minutes of cooling; those with a skinfold thickness of 21-30 mm will receive 40 minutes of cooling; and those with a skinfold thickness of 31-40 mm will receive 60 minutes of cooling. Participants will remain seated for the duration of the cooling treatment.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Those randomized to Group A (n=12, 50% men) will perform the thermoneutral condition first, followed by the cooled condition. Receives: Procedure: Cryotherapy |
| Sequence B | Experimental | Those randomized to Group B (n=12, 50% men) will perform the cooled condition first, followed by the thermoneutral condition. Receives: Procedure: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Unit (MU) Yield
Number of unique motor units successfully identified (decomposed) from quadriceps HDsEMG recordings during maximal voluntary contractions (MVCs) under thermoneutral and cooled conditions.
Measured: Immediately after the intervention
HDsEMG Decomposition Accuracy
Quality/accuracy of motor unit decomposition from quadriceps HDsEMG recorded during MVCs under thermoneutral and cooled conditions, based on decomposition quality metrics generated by the Delsys Neuromap Precision Decomposition III algorithm.
Measured: Immediately after the intervention
Proportion of Analyzable MVC Trials
Percentage of MVC trials that yield HDsEMG data suitable for motor unit decomposition and analysis under thermoneutral and cooled conditions (successful decomposition and acceptable signal quality).
Measured: Immediately after the intervention
Secondary outcomes (2)
Slope of MUAP-FR relationship
Slope of the linear regression relating MU firing rate to MU action potential amplitude during MVCs under thermoneutral and cooled conditions.
Measured: Immediately after the intervention
Y-intercept of MUAP-FR relationship
Y-intercept of the linear regression relating MU firing rate to MU action potential amplitude during MVCs under thermoneutral and cooled conditions.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start20 Jan 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Why it stopped: Research assistants are away for summer break. Expect to resume in September 2026.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliott Arroyo, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381920
- Sponsor's protocol ID
- IRB00026267
- Acronym
- CRYO
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Muscle Cooling on Motor Unit Firing of the Quadriceps: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT07381920
- Acronym / sponsor ID
- CRYO / IRB00026267
- Conditions
- Healthy
- Keywords
- muscle cooling, motor unit behavior, HDsEMG, Quadriceps
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Research assistants are away for summer break. Expect to resume in September 2026.
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 2 Feb 2026 (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.
The overall objective of this pilot study is to establish the feasibility and methodological validity of using high-density surface electromyography to characterize motor unit behavior of the quadriceps under thermoneutral and locally cooled conditions, and to generate preliminary data to inform the design of a larger, hypothesis-driven study.
Detailed description
This randomized, cross-over pilot study will recruit 24 healthy young adults (12 men and 12 women) between the ages of 18 and 35 years. Participants will attend two in-person laboratory visits separated by a minimum of 48 hours. Visit 1 will include informed consent, eligibility confirmation, baseline assessments, and familiarization procedures. Visit 2 will include experimental testing under thermoneutral and cooled conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Procedure: CryotherapyThose randomized to Group A (n=12, 50% men) will perform the thermoneutral condition first, followed by the cooled condition. |
| Sequence B | Experimental | Procedure: CryotherapyThose randomized to Group B (n=12, 50% men) will perform the cooled condition first, followed by the thermoneutral condition. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women between the ages of 18 and 35 years
- Healthy adults, defined as absence of significant acute/chronic medical condition, injury, and/or illness that may compromise subject safety, limit the ability of the participant to complete the study, and/or compromise the objectives of the study as determined by the Principal Investigator.
Key exclusion criteria (15 listed)
- Current diagnosis or history of:
- Current or recent musculoskeletal injury (e.g. fracture, sprain, dislocation) or any physical disability that precludes safe and adequate testing.
- Pregnancy or breastfeeding.
- Thigh circumference greater than 23 inches
- Mid-thigh skinfold thickness greater 40 mm
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 |
|---|---|---|
| CryotherapyFor the cold condition, an Aircast Thigh Pad (Aircast), connected to the Cryo Cuff IC cooler (DJO Global, Vista, California, USA) will be applied to the dominant thigh. The system circulates ice water maintained at approximately 10-15°C with intermittent compression. Cooling duration will be individualized based on mid-thigh skinfold thickness, consistent with published recommendations that account for the effect of subcutaneous tissue on intramuscular cooling9. Participants with a mid-thigh skinfold thickness of 0-10 mm will receive 10 minutes of cooling; those with a skinfold thickness of 11-20 mm will receive 25 minutes of cooling; those with a skinfold thickness of 21-30 mm will receive 40 minutes of cooling; and those with a skinfold thickness of 31-40 mm will receive 60 minutes of cooling. Participants will remain seated for the duration of the cooling treatment. | Procedure or surgery | Sequence A, Sequence B |
Primary outcome
Motor Unit (MU) Yield
Time frame: Immediately after the intervention
Number of unique motor units successfully identified (decomposed) from quadriceps HDsEMG recordings during maximal voluntary contractions (MVCs) under thermoneutral and cooled conditions.
HDsEMG Decomposition Accuracy
Time frame: Immediately after the intervention
Quality/accuracy of motor unit decomposition from quadriceps HDsEMG recorded during MVCs under thermoneutral and cooled conditions, based on decomposition quality metrics generated by the Delsys Neuromap Precision Decomposition III algorithm.
Proportion of Analyzable MVC Trials
Time frame: Immediately after the intervention
Percentage of MVC trials that yield HDsEMG data suitable for motor unit decomposition and analysis under thermoneutral and cooled conditions (successful decomposition and acceptable signal quality).
2 secondary outcomes
Slope of MUAP-FR relationship
Time frame: Immediately after the intervention
Y-intercept of MUAP-FR relationship
Time frame: Immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- 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 study testing Cryotherapy in people with Healthy, run by Wake Forest University 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 15 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: paused, as of the sponsor's last update on 21 Aug 2026. 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.
Are results available for this study?
Results are not available in the source record.
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?
Motor Unit (MU) Yield (time frame: Immediately after the intervention). 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?
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 21 Aug 2026.