Electromyostimulation (EMS) of Astronauts in Spaceflight (Easymotion-2)

NCT06492057 | Enrolling By Invitation DMC

• 1 other identifier: 50WB2329
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective spaceflight study involving an investigational non-risk device called the EasyMotionSkin for whole body electric muscle (myo) stimulation (WB-EMS) onboard the International Space Station (ISS). The purpose of this study is to show:

• optimized exercise outcome with EMS in human spaceflight
• demonstrate efficacy of EMS as alternative inflight exercise protocol
• provide a time-saving and reliable EMS-assisted exercise protocol compliant to astronauts for later use in planetary habitats and future deep space exploration Eight (n=8) astronauts on long duration missions will take part in this study. This experiment uses the following hardware/software (HW \& SW): (A) EasymotionSkin suit (dry electrode muscle stimulation), B) non-invasive hand-held Myoton device (digitized passive muscle stiffness data collection). C) a customized Myoton body template suit (elastic yoga suit with customized anatomical reference labels to aid inflight Myoton data collection on dedicated perforated 2x2 cm small skin fields) at 5 different skin measurement points (MP), neck, back, shoulder, legs. Before and after flight the following tests will be done once: Myoton data collection, dynamometry strength test, magnetic resonance imaging (MRI) for baseline comparison. Researchers will compare data from a non EMS control group (non EMS Astronauts, retrospective) to see if changes of passive muscle stiffness is seen in EMS Astronauts before, during and after spaceflight

Conditions

Myotonia; Muscle Atrophy; Stiffness; Spine; Exercise Overtraining

Keywords

skeletal muscle; passive muscle stiffness; muscle health; electromyostimulation; space flight; countermeasure

Outcome Measures

Primary Outcomes (37)

• Myoton Tone (baseline preflight)

  Passive muscle tone \[Hz\] numerical indices. Abbreviations for Outcome Measures 1-37: Hertz, Hz; Newton/meter, N/m; before launch (preflight), L-; recovery (postflight), R+; inflight days, FD; not earlier than, NET; not later than, NLT; electro-myo-stimulation, EMS; versus/against, vs; surface electromyography, sEMG.

  L-105+/-30 days (time window)

• Myoton Tone (recovery postflight)

  Passive muscle tone \[Hz\] numerical indices. Abbreviations for Outcome Measures 1-37: Hertz, Hz; Newton/meter, N/m; before launch (preflight), L-; recovery (postflight), R+; inflight days, FD; not earlier than, NET; not later than, NLT; electromyostimulation, EMS; versus/against, vs; surface electromyography, sEMG.

  R+30+/-10 days (time window)

• Myoton Tone (inflight, preEMS-1)

  Passive muscle tone \[Hz\] numerical indices. Abbreviations: see Outcome1

  FD20-30 days (time window)

• Myoton Tone (inflight, preEMS-2)

  Passive muscle tone \[Hz\] numerical indices. Abbreviations: see Outcome1

  FD60-80 days (time window)

• Myoton Tone (inflight, post EMS-1)

  Passive muscle tone \[Hz\] numerical indices. Abbreviations: see Outcome1

  NET R-18 days (time window)

• Myoton Tone (inflight, post EMS-2)

  Passive muscle tone \[Hz\] numerical indices. Abbreviations: see Outcome1

  NLT R-12 days (time window)

• Myoton stiffness (baseline, preflight).

  Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1

  L-105+/-30 days (time window)

• Myoton stiffness (recovery, postflight).

  Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1

  R+30+/-10 days (time window)

• Myoton stiffness (inflight, preEMS-1)

  Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1

  FD20-30 days (time window)

• Myoton stiffness (inflight, preEMS-2)

  Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1

  FD60-80 days (time window)

• Myoton stiffness (inflight, postEMS-1)

  Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1

  NET R-18 days (time window)

• Myoton stiffness (inflight, postEMS-2)

  Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1

  NLT R-12 days (time window)

• EMS body stimulation (inflight EMS1)

  1st out of a total of 12 (1/12) single EMS-assisted inflight exercise between NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24. Abbreviations: see Outcome 1.

  NET R-60 and NLT R-21 days (time window)

• EMS body stimulation (inflight EMS2)

  2/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1.

  NET R-60 and NLT R-21 days (time window)

• EMS body stimulation (inflight EMS3)

  3/12 single EMS-assisted inflight exercise, NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out")at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1.

  NET R-60 and NLT R-21 days(time window)

• EMS body stimulation (inflight EMS4)

  4/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out")at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1.

  NET R-60 and NLT R-21 days (time window)

• EMS body stimulation (inflight EMS5)

  5/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out")at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1.

  NET R-60 and NLT R-21 days (time window)

• EMS body stimulation (inflight EMS6)

  6/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out")at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1.

  NET R-60 and NLT R-21 days (time window)

• EMS body stimulation (inflight EMS7)

  7/12 single EMS-assisted inflight exercise, NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out")at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1.

  NET R-60 and NLT R-21 days (time window)

• EMS body stimulation (inflight EMS8)

  8/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1.

  NET R-60 and NLT R-21 days (time window)

• EMS body stimulation (inflight EMS9)

  9/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1.

  NET R-60 and NLT R-21 days (time window)

• EMS body stimulation (inflight EMS10)

  10/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1.

  NET R-60 and NLT R-21 days (time window)

• EMS body stimulation (inflight EMS11)

  11/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1.

  NET R-60 and NLT R-21 days (time window)

• EMS body stimulation (inflight EMS12)

  Last out of a total of twelve (12/12) single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1.

  NET R-60 and NLT R-21 days (time window)

• Dynamometry (baseline, preflight/power).

  Standard muscle isometric/isokinetic tests (power \[Watt\] on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus). Abbreviations: see Outcome 1

  L-105+/-30 days (time window)

• Dynamometry (baseline, preflight/torque).

  Standard muscle isometric/isokinetic tests ( torque \[Nm\]) on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus). Abbreviations: see Outcome 1

  L-105+/-30 days (time window)

• sEMG (baseline, preflight/amplitude).

  Non-invasive sEMG by amplitude on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus) as part of dynamometry. Abbreviations: see Outcome 1

  L-105+/-30 days (time window)

• sEMG (baseline, preflight/frequency).

  Non-invasive sEMG by frequency (Hz) on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus) as part of dynamometry. Abbreviations: see Outcome 1

  L-105+/-30 days (time window)

• Dynamometry (recovery postflight/power).

  Standard muscle isometric/isokinetic tests (power \[Watt\] on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus). Abbreviations: see Outcome 1

  R+30+/-10 days (time window)

• Dynamometry (recovery postflight/torque).

  Standard muscle isometric/isokinetic tests (torque \[Nm\] on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus). Abbreviations: see Outcome 1

  R+30+/-10 days (time window)

• sEMG (recovery postflight/amplitude).

  Non-invasive surface EMG (amplitude) on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus) as part of dynamometry. Abbreviations: see Outcome 1

  R+30+/-10 days (time window)

• sEMG (recovery postflight/frequency).

  Non-invasive surface EMG (Hz) on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus) as part of dynamometry. Abbreviations: see Outcome 1

  R+30+/-10 days (time window)

• Magnetic Resonance Imaging (MRI) (baseline preflight).

  Standard clinical structural analysis by optical sections of lower leg and lumbar back muscle profile/volume area (square/3-D, centimeters). Abbreviations: see Outcome 1

  L-105+/-30 days (time window)

• Magnetic Resonance Imaging (MRI) (recovery postflight).

  Standard clinical structural analysis by optical sections of lower leg and lumbar back muscle profile/volume area (square/3-D, centimeters). Abbreviations: see Outcome 1

  R+30+/-10 days (time window)

• EMS protocol report (ms)

  Multiple measurements (milliseconds=ms) will be aggregated for each of the 12 single inflight EMS session (see Outcome 13-24) to report on inflight EMS protocol and to collect technical data (of muscle stimulation) for whole body inflight EMS monitoring and assessment. see Outcome1

  NET R-60 and NLT R-21 days (time window)

• EMS protocol report (minutes)

  Multiple measurements (duration/min.) will be aggregated for each of the 12 single inflight EMS session (see Outcome 13-24) to report on inflight EMS protocol and to collect technical data (of muscle stimulation) for whole body inflight EMS monitoring and assessment. Abbreviations: see Outcome1

  NET R-60 and NLT R-21 days (time window)

• EMS protocol report (Hz)

  Multiple measurements (frequency/Hz) will be aggregated for each of the 12 single inflight EMS session (see Outcome 13-24) to report on inflight EMS protocol and to collect technical data (of muscle stimulation) for whole body inflight EMS monitoring and assessment. Abbreviations: see Outcome1

  NET R-60 and NLT R-21 days (time window)

Study Arms (1)

EMS (electromyostimulation) participants

EXPERIMENTAL

Healthy Astronauts that perform EMS-assisted inflight exercise onboard the International Space Station

Device: Electromyostimulation (EMS); Device: Myoton; Diagnostic Test: Electromyography (EMG); Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Dynamometry

Interventions

Electromyostimulation (EMS) DEVICE

EasymotionSkin body suit for digitally controlled electric impulses via Easymotion-2 software on crew iPad (frequency, impulse rate, duration) are transferred from integrated dry electrodes of the EMS- stimulation suit to activate surface muscle groups of the body (trunk), arms and legs

Also known as: EMS body muscle stimulation

EMS (electromyostimulation) participants

Myoton DEVICE

The non-invasive Myoton technology collects data from passive muscle properties (tone and stiffness) obtained from selected anatomical surface muscle groups

Also known as: passive muscle properties

EMS (electromyostimulation) participants

Electromyography (EMG) DIAGNOSTIC_TEST

As a standard method, surface EMG collects data from nerve impulse-triggered active muscle contractions, pre/postflight only

Also known as: surface EMG/nerve impulse rate [amplitude/frequency]

EMS (electromyostimulation) participants

Magnetic Resonance Imaging (MRI) DIAGNOSTIC_TEST

MRI is a clinically standard (non-radiation) imaging method to study structural changes of the human body (organs, muscle, bones, tendons) at the macroscopic level, pre/postflight only

Also known as: MRI, Magnetic Resonance Tomography

EMS (electromyostimulation) participants

Dynamometry DIAGNOSTIC_TEST

Dynamometry is a standard functional and diagnostic method to test muscle strength in sports and rehabilitation. pre/postflight only

Also known as: muscle functional test

EMS (electromyostimulation) participants

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Astronauts with active Flight Medical

You may not qualify if:

• Heart disease
• Liver disease
• Diabetes
• Thrombosis
• Extreme blood pressure
• Abdominal \& inguinal hernias (bulges)
• Strong neurological diseases
• Pregnancy
• Cancer

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• German Sport University, Cologne: collaborator

Study Sites (1)

Charité - Universitätsmedizin Berlin

Mitte, State of Berlin, 10117, Germany

Location

Related Publications (3)

• Schoenrock B, Muckelt PE, Hastermann M, Albracht K, MacGregor R, Martin D, Gunga HC, Salanova M, Stokes MJ, Warner MB, Blottner D. Muscle stiffness indicating mission crew health in space. Sci Rep. 2024 Feb 20;14(1):4196. doi: 10.1038/s41598-024-54759-6.

  PMID: 38378866 BACKGROUND

• Muckelt PE, Warner MB, Cheliotis-James T, Muckelt R, Hastermann M, Schoenrock B, Martin D, MacGregor R, Blottner D, Stokes M. Protocol and reference values for minimal detectable change of MyotonPRO and ultrasound imaging measurements of muscle and subcutaneous tissue. Sci Rep. 2022 Aug 11;12(1):13654. doi: 10.1038/s41598-022-17507-2.

  PMID: 35953503 BACKGROUND

• Schoenrock B, Zander V, Dern S, Limper U, Mulder E, Veraksits A, Viir R, Kramer A, Stokes MJ, Salanova M, Peipsi A, Blottner D. Bed Rest, Exercise Countermeasure and Reconditioning Effects on the Human Resting Muscle Tone System. Front Physiol. 2018 Jul 3;9:810. doi: 10.3389/fphys.2018.00810. eCollection 2018.

  PMID: 30018567 BACKGROUND

MeSH Terms

Conditions

Muscular Atrophy; Myotonia; Overtraining Syndrome

Interventions

Electromyography; Magnetic Resonance Imaging; Postmortem Imaging

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fatigue

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography; Tomography; Diagnostic Imaging; Autopsy; Investigative Techniques

Study Officials

• Dieter Blottner, PhD

  Charite-Universitätsmedizin Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Subject A to K
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. (PhD)

Model Details: In the second phase of their long-duration flight (\>130 days or more), each participant wears a personalized Easymotionskin body suit (muscle stimulation suit) controlled by Easymotion App software on crew iPad for only for about 15-20 minutes while performing routine inflight exercise using standard inflight countermeasure devices (treadmill=T2, Cycle Ergometer on ISS, CEVIS; advanced Resistive Exercise Device, ARED) available onboard the ISS. Total EMS exercise time and duration: 12 times EMS plus T2, CEVIS or ARED within 3 weeks on ISS.

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: July 9, 2024
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)