Temporally interfering alternating current stimulation of the muscles of human subjects.

• Conditions: G70.0; G62.9; G72.9; Myasthenia gravis; Polyneuropathy, unspecified; Myopathy, unspecified

• Registration Number: DRKS00028993
• Lead Sponsor: niversitätsmedizin Göttingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Healthy subjects:
1. Male and female healthy participants between the ages of 18-40.
2 Free willing participation and written, informed consent of all subjects obtained prior
to the start of the study

Patients:
1. Male and female participants over the age of 18
2. Free willing participation and written, informed consent of all subjects obtained prior
to the start of the study.
3. Reliable diagnosis of any neuromuscular disease as indicated below

Exclusion Criteria

Healthy subjects:
1. History or evidence of chronic or residual neurological or muscle related disease in the
study applicant or family history of the applicant
2. Pacemaker, Metal implants in the body.
3. Age; < 18 or > 40 years old.
4. Any serious medical conditions (disease of the internal organs) or psychiatric illness,
including schizophrenia, mania or depression.
5. Pregnancy or breast-feeding.
6. Alcohol, medication or drug addiction.
7. Any legal reason why the candidate cannot participate.
8. Participation in another scientific or clinical study within the last 8 weeks.
9. Active or suspected malignancy (cancer)
10. Sensory loss in the area to be stimulated
11. Severe paresis or complete plegia of the area to be stimulated
12. Acute dermatological conditions
13. Diagnosed neuromuscular, cardiac, or respiratory disorders

Patients with NMD:
1. Unclear neuromuscular symptoms without existing reliable diagnosis
2. Neuromuscular disease not indicated in the entities included in this study
3. Pacemaker, Metal implants in the body.
4. Age < 18 old.
5. Any serious medical conditions (disease of the internal organs) or psychiatric illness,
including schizophrenia, mania or depression.
6. Pregnancy or breast-feeding.
7. Alcohol, medication or drug addiction.
8. Any legal reason why the candidate cannot participate.
9. Active or suspected malignancy (cancer)
10. Sensory loss in the area to be stimulated
11. Severe paresis or complete plegia of the area to be stimulated
12. Acute dermatological conditions
13. Diagnosed cardiac, or respiratory disorders

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
What: Compliance and apittude of the use of TIS in patients with different neuromuscular disorders <br>When: End of data collection for each patient<br>How: Results of TIS-measurement (used frequency, amplitude, pain threshold), results of ultrasound correlation (muscle contraction, semiquantitative scale), correlation with disease specific parameters (diagnosis, disease duration..)

Secondary Outcome Measures

Name	Time	Method
Differences in response of nerve-muscle unit to usage of TIS on peripheral skeletal muscle in patients with different neuromuscular disorders as well as compared to measurements of healthy controls.