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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 after multiple sessions of treatment.
Subjects will receive 10-session BreEStim and 10-session EStim treatment in a random order. The interval between BreEStim and EStim is at least 2 weeks. The following assessment will be made before and after
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BreEStim 240, then EStim 240 | Experimental | BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. |
|
| EStim 240, then BreEstim 240 | Experimental | EStim is transcutaneous electrical nerve stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BreEStim 240 | Device | 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Pain 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. 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. | From Baseline to completion of 10 intervention sessions (about 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection 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. 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. |
| 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, after 10 intervention sessions, about 2 weeks |
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 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (2 Weeks) |
| |||||||||||||
| Washout (About 3 to 12 Months) |
| |||||||||||||
| Second Intervention (2 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Average Change in Pain 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. 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. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to completion of 10 intervention sessions (about 2 weeks) |
|
up to 18 months
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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 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. |
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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 20, 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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| EStim 240 | Device | 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect. |
|
| From Baseline to completion of 10 intervention sessions (about 2 weeks) |
| Average 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. 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. | From Baseline to completion of 10 intervention sessions (about 2 weeks) |
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| NOT COMPLETED |
|
| BG001 |
| 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. |
| 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 |
|
| OG001 |
| EStim 240 |
EStim is transcutaneous electrical nerve stimulation. EStim 240: 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect. |
|
|
| Secondary | Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection 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. 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. | Posted | Mean | Standard Deviation | mA | From Baseline to completion of 10 intervention sessions (about 2 weeks) |
|
|
|
| Secondary | Average 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. 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. | Posted | Mean | Standard Deviation | mA | From Baseline to completion of 10 intervention sessions (about 2 weeks) |
|
|
|
| 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, after 10 intervention sessions, about 2 weeks | Participants |
| 0 |
| 11 |
| 0 |
| 11 |
| 11 |
| 11 |
| EG001 | EStim 240 | EStim is transcutaneous electrical nerve stimulation. EStim 240: 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect. | 0 | 11 | 0 | 11 | 11 | 11 |
| Discomfort | Skin and subcutaneous tissue 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 |