N/A
Completed N=2
High Definition Neuromuscular Stimulation in Tetraplegia
Spinal Cord Injury at C4-C6 Level
Source: ClinicalTrials.gov NCT04075812 ↗
Enrolled (actual)
2
Serious AEs
50.0%
Results posted
Aug 2021
Primary outcomePrimary: Change in Voluntary Movement — 2; 0 Participants
Summary
The purpose of this study is to demonstrate high definition non-invasive neuromuscular stimulation of an upper extremity in tetraplegic participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Voluntary Movement |
2; 0 | — |
| SECONDARY Change in Functional Movement |
2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Must be 21 years or older.
- Must be tetraplegic (C4-6 ASIA A)
- 12 months post injury and neurologically stable
- Participant is willing to comply with all follow-up evaluations at the specified times.
- Participant is able to provide informed consent prior to enrollment in the study.
- The participant is fluent in English.
Exclusion Criteria
- No active wound healing or skin breakdown issues.
- No history of poorly controlled autonomic dysreflexia.
- Other implantable devices such as heart/brain pacemakers
- Subjects who rely on ventilators
Data sourced from ClinicalTrials.gov (NCT04075812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.