Trial Outcomes & Findings for A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 3) (NCT NCT04751526)

Last Updated: 2025-03-20

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. For each session change is reported as \[(VAS score at baseline) - (VAS Score 10 minutes after each intervention)\] - a positive value indicates that the score (and pain level) decreased. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

From Baseline to completion of 10 intervention sessions (about 2 weeks)

Results posted on

2025-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	BreEStim 240, Then EStim 240 BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. BreEStim 240: 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect. EStim 240: 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.	EStim 240, Then BreEstim 240 EStim is transcutaneous electrical nerve stimulation. BreEStim 240: 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect. EStim 240: 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
First Intervention (2 Weeks) STARTED	9	9
First Intervention (2 Weeks) COMPLETED	9	8
First Intervention (2 Weeks) NOT COMPLETED	0	1
Washout (About 3 to 12 Months) STARTED	9	8
Washout (About 3 to 12 Months) COMPLETED	9	8
Washout (About 3 to 12 Months) NOT COMPLETED	0	0
Second Intervention (2 Weeks) STARTED	4	7
Second Intervention (2 Weeks) COMPLETED	4	7
Second Intervention (2 Weeks) 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 3)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BreEStim 240, Then EStim 240 n=9 Participants BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. BreEStim 240: 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect. EStim 240: 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.	EStim 240, Then BreEstim 240 n=9 Participants EStim is transcutaneous electrical nerve stimulation. BreEStim 240: 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect. EStim 240: 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Others	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to completion of 10 intervention sessions (about 2 weeks)

Outcome measures

Outcome measures
Measure	BreEStim 240 n=16 Participants BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. BreEStim 240: 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.	EStim 240 n=12 Participants EStim is transcutaneous electrical nerve stimulation. EStim 240: 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
Average Change in Pain as Measured by the Visual Analog Scale (VAS)	1.38 score on a scale Standard Deviation 0.69	0.93 score on a scale Standard Deviation 0.43

SECONDARY outcome

Timeframe: From Baseline to completion of 10 intervention sessions (about 2 weeks)

Electrical 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. For each session change is reported is reported as \[(EST at 5 minutes after intervention) - (EST at baseline)\] - a positive value indicates a decrease in sensation perception. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.

Outcome measures

Outcome measures
Measure	BreEStim 240 n=16 Participants BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. BreEStim 240: 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.	EStim 240 n=12 Participants EStim is transcutaneous electrical nerve stimulation. EStim 240: 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection Threshold (EST)	-0.22 mA Standard Deviation 0.27	-0.11 mA Standard Deviation 0.37

SECONDARY outcome

Timeframe: From Baseline to completion of 10 intervention sessions (about 2 weeks)

An 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. For each session change is reported as \[(EPT at 5 minutes after intervention) - (EPT at baseline)\] - a positive value indicates an increase in pain threshold. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.

Outcome measures

Outcome measures
Measure	BreEStim 240 n=16 Participants BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. BreEStim 240: 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.	EStim 240 n=12 Participants EStim is transcutaneous electrical nerve stimulation. EStim 240: 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
Average Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT)	3.69 mA Standard Deviation 3.87	0.99 mA Standard Deviation 1.51

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, after 10 intervention sessions, about 2 weeks

HRV is a measure of the variation in time between each heartbeat. We use HRV to identify the autonomic nervous system changes after intervention treatment.

Outcome measures

Outcome data not reported

Adverse Events

BreEStim 240

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

EStim 240

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BreEStim 240 n=11 participants at risk BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. BreEStim 240: 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.	EStim 240 n=11 participants at risk EStim is transcutaneous electrical nerve stimulation. EStim 240: 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
Skin and subcutaneous tissue disorders Redness	9.1% 1/11 • up to 18 months	9.1% 1/11 • up to 18 months
Skin and subcutaneous tissue disorders Discomfort	100.0% 11/11 • up to 18 months	100.0% 11/11 • up to 18 months

Additional Information

Sheng Li, MD, PhD

The University of Texas Health Science Center at Houston

Phone: 713-797-7125

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place