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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom limb pain in patients after limb amputation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BreEStim 120, then BreEStim 240 | Experimental | BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment. |
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| BreEStim 240, then BreEStim 120 | Experimental | BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BreEStim 120 | Device | 120 BreEStim stimuli will applied for about 10-15 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Level as Measured by the Visual Analog Scale (VAS). | 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 | Baseline, 10 minutes after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST) | 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. Change is reported as [(EST at 5 minutes after intervention) - (EST at baseline)] - a positive value indicates a decrease in sensation perception. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate Variability (HRV) Measured by Electrocardiogram (ECG) | 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. | Baseline, 10 minutes after intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheng Li, MD, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | BreEStim 120, Then BreEStim 240 | BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment. BreEStim 120: 120 BreEStim stimuli will applied for about 10-15 minutes. BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes. |
| FG001 | BreEStim 240, Then BreEStim 120 | BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment. BreEStim 120: 120 BreEStim stimuli will applied for about 10-15 minutes. BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (10-15 Minutes) |
| |||||||||||||
| Washout (About 1-17 Days) |
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| Second Intervention (20-30 Minutes) |
|
0 participants were assigned to the BreEStim 240, then BreEStim 120 arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | BreEStim 120, Then BreEStim 240 | BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment. BreEStim 120: 120 BreEStim stimuli will applied for about 10-15 minutes. BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Level as Measured by the Visual Analog Scale (VAS). | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline, 10 minutes after intervention |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BreEStim 120 | BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment. BreEStim 120: 120 BreEStim stimuli will applied for about 10-15 minutes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheng Li, MD, PhD | The University of Texas Health Science Center at Houston | 713-797-7125 | sheng.li@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2020 | Feb 19, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 10, 2021 | Feb 19, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010591 | Phantom Limb |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| BreEStim 240 | Device | 240 BreEStim stimuli will applied for about 20-30 minutes. |
|
| Baseline, 5 minutes after intervention |
| Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT) | 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. Change is reported as [(EPT at 5 minutes after intervention) - (EPT at baseline)] - a positive value indicates an increase in pain threshold. | Baseline, 5 minutes after intervention |
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| NOT COMPLETED |
|
| BG001 | BreEStim 240, Then BreEStim 120 | BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment. BreEStim 120: 120 BreEStim stimuli will applied for about 10-15 minutes. BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BreEStim 240 |
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment. BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes. |
|
|
| Secondary | Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST) | 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. Change is reported as [(EST at 5 minutes after intervention) - (EST at baseline)] - a positive value indicates a decrease in sensation perception. | Posted | Mean | Standard Deviation | milliampere (mA) | Baseline, 5 minutes after intervention |
|
|
|
| Secondary | Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT) | 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. Change is reported as [(EPT at 5 minutes after intervention) - (EPT at baseline)] - a positive value indicates an increase in pain threshold. | Posted | Mean | Standard Deviation | milliampere (mA) | Baseline, 5 minutes after intervention |
|
|
|
| Other Pre-specified | Change in Heart Rate Variability (HRV) Measured by Electrocardiogram (ECG) | 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. | Not Posted | Baseline, 10 minutes after intervention | Participants |
| 0 |
| 17 |
| 0 |
| 17 |
| 17 |
| 17 |
| EG001 | BreEStim 240 | BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment. BreEStim 240: 240 BreEStim stimuli will applied for about 20-30 minutes. | 0 | 17 | 0 | 17 | 17 | 17 |
| Discomfort | General disorders | Non-systematic Assessment |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |