NCT07381920

Brief 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 larger, hypothesis-driven study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
12mo left

Started Jan 2026

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Jan 2026May 2027

First Submitted

Initial submission to the registry

January 19, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

January 19, 2026

Last Update Submit

February 23, 2026

Conditions

Keywords

muscle coolingmotor unit behaviorHDsEMGQuadriceps

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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).

    Immediately after the intervention

Secondary Outcomes (2)

  • Slope of MUAP-FR relationship

    Immediately after the intervention

  • Y-intercept of MUAP-FR relationship

    Immediately after the intervention

Other Outcomes (1)

  • Maximal Voluntary Contraction (MVC) Force

    Immediately after the intervention

Study Arms (2)

Sequence A

EXPERIMENTAL

Those randomized to Group A (n=12, 50% men) will perform the thermoneutral condition first, followed by the cooled condition.

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.

Procedure: Cryotherapy

Interventions

CryotherapyPROCEDURE

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.

Sequence ASequence B

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Health and Exercise Science at Wake Forest University

Winston-Salem, North Carolina, 27109, United States

RECRUITING

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Eliott Arroyo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 2, 2026

Study Start

January 20, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations