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Trial Outcomes & Findings for Treatment Parameters for the Empower Neuromodulation System (ENS) (NCT NCT03807544)

NCT ID: NCT03807544

Last Updated: 2020-11-17

Results Overview

Compare two active treatment electrode locations to evaluate the effect of electrode placement on the appearance of sensory nerve action potentials, including tingling sensation, along the stimulated nerve using electromyography (EMG).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

2 hours, length of study visit

Results posted on

2020-11-17

Participant Flow

Participant milestones

Participant milestones
Measure
TENS Treatment Arm
This study is a usability study, where all subjects will receive the same experimental treatment (both palms and wrists) for their single visit. TENS: Transcutaneous electrical nerve stimulation
Overall Study
STARTED
17
Overall Study
COMPLETED
17
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment Parameters for the Empower Neuromodulation System (ENS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
TENS Treatment Arm
n=17 Participants
This study is a usability study, where all subjects will receive the same experimental treatment for their single visit. TENS: Transcutaneous electrical nerve stimulation
Age, Continuous
46.82 Years
n=5 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
3 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=5 Participants
Race (NIH/OMB)
White
9 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
17 participants
n=5 Participants

PRIMARY outcome

Timeframe: 2 hours, length of study visit

Compare two active treatment electrode locations to evaluate the effect of electrode placement on the appearance of sensory nerve action potentials, including tingling sensation, along the stimulated nerve using electromyography (EMG).

Outcome measures

Outcome measures
Measure
TENS Location - Palm
n=17 Participants
Measuring SNAP/Tingling off of the Palm location (active treatment site)
TENS Location - Wrist
n=17 Participants
Measuring SNAP/Tingling off of the Wrist location (active treatment site)
Number of Participants Who Experienced Effective Electrode Placement
17 Participants
17 Participants

Adverse Events

TENS Treatment Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trials

Theranova

Phone: 14159268616

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place