Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BreEStim 120, then EStim 120 | Experimental | BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation. |
|
| EStim 120, then BreEStim 120 | Experimental | BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BreEStim | Device | 120 BreEStim stimuli will applied for about 10-30 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 |
|---|---|---|
| Difference 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. 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (15-30 Minutes) |
| |||||||||||||
| Washout (About 3-14 Days) |
| |||||||||||||
| Second Intervention (15-30 Minutes) |
|
0 participants were assigned to the EStim 120, then BreEStim 120 arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| 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
Not provided
Not provided
| 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 BreEStim stimuli will applied for about 10-30 minutes. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| 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 |
Not provided
| 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 |
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010591 | Phantom Limb |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| EStim | Device | 120 EStim stimuli will applied for about 10-30 minutes. |
|
| Baseline, 5 minutes after intervention |
| Change in Pain Threshold on Amputated Limb Measured by Electrical Pain 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 |
| Baseline, 10 minutes after intervention |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| 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. |
| 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 |
|
|
|
| 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 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 | Difference 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. 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. | Not Posted | Baseline, 10 minutes after intervention | Participants |
| 0 |
| 15 |
| 0 |
| 15 |
| 15 |
| 15 |
| EG001 | EStim 120 | EStim is transcutaneous electrical nerve stimulation. 120 EStim stimuli will applied for about 10-30 minutes. | 0 | 15 | 0 | 15 | 15 | 15 |
| discomfort | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |