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| ID | Type | Description | Link |
|---|---|---|---|
| UG3NS139014 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and sham BreEStim and Transcutaneous Electrical Nerve Stimulation (TENS) in management of neuropathic pain in patients after spinal cord injury (SCI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active BreEStim Treatment | Experimental |
| |
| Sham BreEStim Treatment | Sham Comparator |
| |
| The transcutaneous electrical nerve stimulation (TENS) Treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active BreEStim Treatment | Device | During the Active BreEStim Treatment session, participants will remain relaxed while breathing is monitored using a nasal cannula. Surface electrodes will be placed over the median nerve at the wrist or another selected peripheral nerve. Electrical stimulation will be synchronized with voluntary breathing and delivered at an individually tolerated intensity for approximately 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. Mean VAS difference will be compared. | Baseline, 10-15 minutes after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| the difference in the percentage of responders between active BreEStim and Sham BreEStim groups | Given sham-controlled design, the investigators define responders as individual participants who achieve at least a 30% reduction in pain from their individual baseline scores. | Baseline, 10-15 minutes after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Li, MD, PhD | Contact | (713) 797-7125 | sheng.li@uth.tmc.edu | |
| Shengai Li, MS | Contact | 713-797-7561 | shengai.li@uth.tmc.edu |
| 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 at Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| Sham BreEStim Treatment | Device | During the Sham BreEStim Treatment session, participants will remain relaxed while breathing is monitored using a nasal cannula. Surface electrodes will be placed over the median nerve at the wrist or another selected peripheral nerve. Electrical stimulation will be synchronized with voluntary breathing and delivered at the sensory threshold level for approximately 30 minutes. |
|
| The TENS Treatment | Device | During the TENS Treatment session, participants will remain relaxed while transcutaneous electrical stimulation is applied through surface electrodes placed over the painful area. Stimulation will be delivered at an individually tolerated intensity for approximately 30 minutes. |
|
| the difference in the percentage of responders between between active BreEStim and transcutaneous electrical nerve stimulation (TENS) groups. |
Given sham-controlled design, the investigators define responders as individual participants who achieve at least a 30% reduction in pain from their individual baseline scores. |
| Baseline, 10-15 minutes after intervention |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |