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NCT Number: NCT07381920

Effects of Muscle Cooling on Motor Unit Firing of the Quadriceps

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Health and Exercise Science at Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location status: Recruiting

Location contact

Eliott Arroyo, PhD

CONTACT

[email protected]

336-758-5847

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • 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

Treatment and study plan

cryotherapy

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. Slope of MUAP-FR relationship

    Time frame: Immediately after the intervention

    Slope of the linear regression relating MU firing rate to MU action potential amplitude during MVCs under thermoneutral and cooled conditions.

  2. Y-intercept of MUAP-FR relationship

    Time frame: Immediately after the intervention

    Y-intercept of the linear regression relating MU firing rate to MU action potential amplitude during MVCs under thermoneutral and cooled conditions.

Other outcomes

  1. Maximal Voluntary Contraction (MVC) Force

    Time frame: Immediately after the intervention

    Peak knee extensor force (N) achieved during MVC testing under thermoneutral and cooled conditions.

Study contacts

Contact information is provided by the study sponsor or research team.

Eliott Arroyo, PhD

CONTACT

[email protected]

336-758-5847

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Official study title

Effects of Muscle Cooling on Motor Unit Firing of the Quadriceps: A Pilot Feasibility Study

Acronym: CRYO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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