Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Institute for Rehabilitation and Research (TIRR) | UNKNOWN |
| Baylor College of Medicine | OTHER |
| Case Western Reserve University | OTHER |
| University of Houston |
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to evaluate the effects upon the bladder of electric stimulation of the leg's tibial nerve in people with acute spinal cord injury with an intervention called transcutaneous tibial nerve stimulation (TTNS).
In this study, TTNS will be used to help neurogenic bladder in SCI. First, acute SCI subjects which respond to TTNS will be identified as seen on urodynamic studies (USD). Then, responders will be invited to participate in a randomized control trial of a 2-week protocol of TTNS to test for safety and efficacy during inpatient rehabilitation to evaluate bladder changes based upon pre- and post- urodynamic testing, as well as 2-month follow-up.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Tibial Nerve Stimulation | Experimental | Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol. |
|
| Control | Sham Comparator | Sham stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Tibial Nerve Stimulation | Device | 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Infection | All infections were urinary tract infections (UTIs). | about 4 weeks |
| Number of Participants With Skin Irritation | Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury. | about 4 weeks |
| Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital | about 4 weeks | |
| Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS) | Participants received 30 minutes of TTNS (or sham stimulation) on each of 10 days over a 16-day period, and on each of the 10 days, pain was recorded immediately before stimulation (baseline) and at about 30 minutes later at the end of stimulation. For a single subject's "mean change in pain score": [Average of the post-stimulation measurements for all 10 time points] minus [Average of baseline measurements for all 10 time points time point] = [mean change in pain score]. The value reported is the mean of all participants' "mean change in pain score." The range of possible pain scores on the numeric pain scale is 1 to 10, with higher scores indicating higher level of pain. | baseline, about 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Detrusor Pressure as Evaluated by Urodynamic Study | baseline | |
| Maximum Detrusor Pressure as Evaluated by Urodynamic Study | 2 weeks | |
| Maximum Bladder Capacity as Evaluated by Urodynamic Study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Argyrios Stampas, MD | University of Texas at Houston Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30837835 | Derived | Stampas A, Gustafson K, Korupolu R, Smith C, Zhu L, Li S. Bladder Neuromodulation in Acute Spinal Cord Injury via Transcutaneous Tibial Nerve Stimulation: Cystometrogram and Autonomic Nervous System Evidence From a Randomized Control Pilot Trial. Front Neurosci. 2019 Feb 19;13:119. doi: 10.3389/fnins.2019.00119. eCollection 2019. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Transcutaneous Tibial Nerve Stimulation | Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol. Transcutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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 | Oct 4, 2016 |
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
|
| Control | Device | 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero. |
|
| baseline |
| Maximum Bladder Capacity as Evaluated by Urodynamic Study | 2 weeks |
| FG001 | Control | Control (Sham stimulation). Control: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Transcutaneous Tibial Nerve Stimulation | Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol. Transcutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis. |
| BG001 | Control | Control (Sham stimulation). Control: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Neurologic Level Number | The neurologic level number indicates the degree of neurologic functioning, with higher numbers indicating a higher degree of neurologic functioning. This is a continuous scale with 30 levels beginning at C1 (closest to the head) and moving caudal along the body to S5--C1 corresponds to level 1 and S5 corresponds to level 30. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Number of Days from Injury | Mean | Standard Deviation | days |
| |||||||||||||||
| Admission Functional Independence Measure (FIM) motor subscale | The FIM motor subscale consists of 13 items: Eating, Grooming, Bathing, Dressing (upper body), Dressing (lower body), Toileting, Bladder management, Bowel management, Transfers (bed/chair/wheelchair), Transfers (toilet), Transfers (bath/shower), Walk/wheelchair, and Stairs. Each individual item is scored from 1 to 7. The range of total scores is 13 to 91, with a higher score indicating more independence in performing the task associated with each item. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Admission Functional Independence Measure (FIM) bladder item | The FIM bladder item (which is part of the FIM motor subscale) is scored from 1 to 7, with a range of possible scores from 1 to 7. A higher score indicates more independence in bladder management. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Admission Functional Independence Measure (FIM) cognition subscale | The FIM cognitive subscale consists of 5 items: Comprehension, Expression, Social interaction, Problem solving, and Memory. Each individual item is scored from 1 to 7. The range of total scores is 5 to 35, with a higher score indicating more independence in performing the task associated with each item. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Number of Participants with Tetraplegia | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants with American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A | Injuries are classified in as being neurologically "complete" or "incomplete" based "Sacral Sparing," which refers to the presence of sensory or motor function in the most caudal sacral segments as determined by the examination (i.e. preservation of light touch or pin prick sensation at the S4-5 dermatome, DAP or voluntary anal sphincter contraction). A complete injury is defined as the absence of sacral sparing, whereas an incomplete injury is defined as the presence of sacral. Grade A = Complete. No sensory or motor function is preserved in the sacral segments S4-S5. | Count of Participants | Participants |
| |||||||||||||||
| American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade B | See ASIA Grade A baseline measure description for further description of ASIA grading. Grade B = Sensory incomplete. Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5, AND no motor function is preserved more than three levels below the motor level on either side of the body. | Count of Participants | Participants |
| |||||||||||||||
| American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade C | See ASIA Grade A baseline measure description for further description of ASIA grading. Grade C = Motor incomplete. Motor function is preserved below the neurological level of injury, and more than half of key muscle functions below the single neurological level of injury have a muscle grade less than 3 (Grades 0-2). | Count of Participants | Participants |
| |||||||||||||||
| American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade D | See ASIA Grade A baseline measure description for further description of ASIA grading. D = Motor incomplete. Motor function is preserved below the neurological level of injury, and at least half (half or more) of key muscle functions below the neurological level of injury have a muscle grade >3. | Count of Participants | 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 | Number of Participants With Infection | All infections were urinary tract infections (UTIs). | Posted | Count of Participants | Participants | about 4 weeks |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With Skin Irritation | Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury. | Posted | Count of Participants | Participants | about 4 weeks |
| ||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital | Posted | Count of Participants | Participants | about 4 weeks |
|
| ||||||||||||||||||||||||||||||||
| Primary | Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS) | Participants received 30 minutes of TTNS (or sham stimulation) on each of 10 days over a 16-day period, and on each of the 10 days, pain was recorded immediately before stimulation (baseline) and at about 30 minutes later at the end of stimulation. For a single subject's "mean change in pain score": [Average of the post-stimulation measurements for all 10 time points] minus [Average of baseline measurements for all 10 time points time point] = [mean change in pain score]. The value reported is the mean of all participants' "mean change in pain score." The range of possible pain scores on the numeric pain scale is 1 to 10, with higher scores indicating higher level of pain. | Posted | Mean | Standard Deviation | units on a scale | baseline, about 30 minutes |
| |||||||||||||||||||||||||||||||
| Secondary | Maximum Detrusor Pressure as Evaluated by Urodynamic Study | Posted | Mean | Standard Deviation | cm H2O | baseline |
|
| |||||||||||||||||||||||||||||||
| Secondary | Maximum Detrusor Pressure as Evaluated by Urodynamic Study | One subject declined to repeat the post-TTNS urodynamic study, leaving 11 remaining in the TTNS group for the urodynamic measurements. | Posted | Mean | Standard Deviation | cm H2O | 2 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Maximum Bladder Capacity as Evaluated by Urodynamic Study | Posted | Mean | Standard Deviation | mL | baseline |
|
| |||||||||||||||||||||||||||||||
| Secondary | Maximum Bladder Capacity as Evaluated by Urodynamic Study | One subject declined to repeat the post-TTNS urodynamic study, leaving 11 remaining in the TTNS group for the urodynamic measurements. | Posted | Mean | Standard Deviation | mL | 2 weeks |
|
About 4 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 | Transcutaneous Tibial Nerve Stimulation | Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol. Transcutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG001 | Control | Control (Sham stimulation). Control: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero. | 0 | 7 | 0 | 7 | 3 | 7 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis/Pulmonary Embolism | Vascular disorders | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Pressure Injury | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Argyrios Stampas, MD | The University of Texas Health Science Center at Houston | (713) 797-5007 | Argyrios.Stampas@uth.tmc.edu |
| Aug 7, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
Control (Sham stimulation).
Control: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|