Trial Outcomes & Findings for A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 1) (NCT NCT04750525)
NCT ID: NCT04750525
Last Updated: 2025-03-12
Results Overview
VAS scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain", a higher score indicating a higher level of pain. Change is reported as \[(VAS score at baseline) - (VAS Score 10 minutes after intervention)\] - a positive value indicates that the score (and pain level) decreased
COMPLETED
NA
15 participants
Baseline, 10 minutes after intervention
2025-03-12
Participant Flow
Participant milestones
| Measure |
BreEStim 120, Then EStim 120
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.
BreEStim: 120 BreEStim stimuli will applied for about 10-30 minutes.
EStim: 120 EStim stimuli will applied for about 10-30 minutes.
|
EStim 120, Then BreEStim 120
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.
BreEStim: 120 BreEStim stimuli will applied for about 10-30 minutes.
EStim: 120 EStim stimuli will applied for about 10-30 minutes.
|
|---|---|---|
|
First Intervention (15-30 Minutes)
STARTED
|
15
|
0
|
|
First Intervention (15-30 Minutes)
COMPLETED
|
15
|
0
|
|
First Intervention (15-30 Minutes)
NOT COMPLETED
|
0
|
0
|
|
Washout (About 3-14 Days)
STARTED
|
15
|
0
|
|
Washout (About 3-14 Days)
COMPLETED
|
15
|
0
|
|
Washout (About 3-14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (15-30 Minutes)
STARTED
|
15
|
0
|
|
Second Intervention (15-30 Minutes)
COMPLETED
|
15
|
0
|
|
Second Intervention (15-30 Minutes)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 1)
Baseline characteristics by cohort
| Measure |
BreEStim 120, Then EStim 120
n=15 Participants
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.
BreEStim: 120 BreEStim stimuli will applied for about 10-30 minutes.
EStim: 120 EStim stimuli will applied for about 10-30 minutes.
|
EStim 120, Then BreEStim 120
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.
BreEStim: 120 BreEStim stimuli will applied for about 10-30 minutes.
EStim: 120 EStim stimuli will applied for about 10-30 minutes.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
—
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
—
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
—
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
6 Participants
n=5 Participants
|
—
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
—
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
—
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 10 minutes after interventionVAS scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain", a higher score indicating a higher level of pain. Change is reported as \[(VAS score at baseline) - (VAS Score 10 minutes after intervention)\] - a positive value indicates that the score (and pain level) decreased
Outcome measures
| Measure |
BreEStim 120
n=15 Participants
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 BreEStim stimuli will applied for about 10-30 minutes.
|
EStim 120
n=15 Participants
EStim is transcutaneous electrical nerve stimulation. 120 EStim stimuli will applied for about 10-30 minutes.
|
|---|---|---|
|
Change in Pain Level as Measured by the Visual Analog Scale (VAS).
|
1.38 score on a scale
Standard Deviation 1.24
|
1.27 score on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Baseline, 5 minutes after interventionElectrical Sensation Threshold (EST) is the minimum electrical current intensity that a person can reliably perceive as a sensation on their skin. This threshold is self-reported by the subjects, and electrical intensity values are recorded when participants first detect the electrical stimulation. Change is reported as \[(EST at 5 minutes after intervention) - (EST at baseline)\] - a positive value indicates a decrease in sensation perception.
Outcome measures
| Measure |
BreEStim 120
n=15 Participants
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 BreEStim stimuli will applied for about 10-30 minutes.
|
EStim 120
n=15 Participants
EStim is transcutaneous electrical nerve stimulation. 120 EStim stimuli will applied for about 10-30 minutes.
|
|---|---|---|
|
Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST)
|
1.00 milliampere (mA)
Standard Deviation 4.34
|
0.44 milliampere (mA)
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Baseline, 5 minutes after interventionAn Electrical Pain Threshold (EPT) refers to the minimum intensity of electrical stimulation required to produce a perceptible pain sensation on a person's skin, essentially measuring the point at which an electrical current becomes painful. The EPT is self-reported by subjects when they feel the electrical intensity begins to cause pain. Change is reported as \[(EPT at 5 minutes after intervention) - (EPT at baseline)\] - a positive value indicates an increase in pain threshold.
Outcome measures
| Measure |
BreEStim 120
n=15 Participants
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 BreEStim stimuli will applied for about 10-30 minutes.
|
EStim 120
n=15 Participants
EStim is transcutaneous electrical nerve stimulation. 120 EStim stimuli will applied for about 10-30 minutes.
|
|---|---|---|
|
Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Threshold (EPT)
|
3.99 milliampere (mA)
Standard Deviation 19.18
|
3.39 milliampere (mA)
Standard Deviation 7.14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 10 minutes after interventionHRV is a measure of the variation in time between each heartbeat. We use HRV to identify the autonomic nervous system changes after intervention treatment. A 5-minute HRV will be recorded prior to the intervention, and 10 mins after the intervention. In this study, the major HRV outcome measurement parameters we choose include: SDNN (standard deviation of normal-to-normal intervals), RMSSD (root mean square of successive differences), and pNN50 (percentage of adjacent RR intervals differing by more than 50ms). SDNN represents the overall variability in the time intervals between heartbeats, providing a general measure of autonomic nervous system function. RMSSD primarily reflects short-term variations in heart rate, often considered a good indicator of parasympathetic activity. pNN50 Measures the proportion of consecutive heartbeats with a significant difference in interval, reflecting the instantaneous changes in heart rate and parasympathetic activity and modulation.
Outcome measures
Outcome data not reported
Adverse Events
BreEStim 120
EStim 120
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BreEStim 120
n=15 participants at risk
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 BreEStim stimuli will applied for about 10-30 minutes.
|
EStim 120
n=15 participants at risk
EStim is transcutaneous electrical nerve stimulation. 120 EStim stimuli will applied for about 10-30 minutes.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Redness
|
26.7%
4/15 • 3 weeks
|
26.7%
4/15 • 3 weeks
|
|
General disorders
discomfort
|
100.0%
15/15 • 3 weeks
|
100.0%
15/15 • 3 weeks
|
Additional Information
Sheng Li, MD, PhD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place