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| Name | Class |
|---|---|
| TIRR/Mission Connect | OTHER |
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The purpose of the study is to investigate the effects of a novel therapeutic approach with transcutaneous spinal direct current stimulation (tsDCS) to promote functional recovery and spasticity in chronic spinal cord injury (SCI).
The purpose of the study is to investigate the effects of a novel therapeutic approach to promote functional recovery and spasticity in chronic SCI. The tsDCS effect on neuro-physiological measures such as H reflex and somatosensory evoked potential (SSEP) wiil be evaluated in subjects with SCI. This incremental, design will allow the establishment of strong electrophysiological data prior to rapid clinical translation of the findings about this promising, early-stage technique.
The central hypothesis is twofold: 1) active tsDCS will lead to a change in Hmax/M max ratio than sham tsDCS, in a polarity dependent manner; and 2) active tsDCS will lead to a change in SSEP amplitude and latency, in a polarity dependent manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS | Experimental | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
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| Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS | Experimental | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
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| Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS | Experimental | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
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| Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS | Experimental | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anodal tsDCS | Device | During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Hmax | Immediately before application of tsDCS and after application of tsDCS, Hmax will be obtained from soleus muscle by stimulation of tibial nerve. The H-reflex is a compound muscle action potential elicited by low-threshold electrical stimulation of afferent fibers in the mixed nerve with subsequent monosynaptic excitation of alpha motoneurons. Changes in the excitability of the reflex pathway are estimated by measuring the amplitude of the reflex. | 10 minutes before intervention, 10 minutes after intervention |
| Change in Somatosensory Evoked Potential (SSEP) | A somatosensory evoked potential (SSEP) is the electrical activity response measured at the skin's surface along ascending sensory pathway following controlled peripheral nerve stimulation by tsDCS. For recording posterior tibial nerve SSEPs, the nerve is stimulated at the ankle, with the cathode midway between the Achilles tendon and the medial malleolus and the anode 3 cm distal to the cathode. Nerve stimulation should consist of a 0.1-0.2 ms duration square wave pulse at 3-5 Hertz (Hz). These pulses will be delivered by constant voltage stimulator applied transcutaneously over the targeted nerve. The stimulation intensity would exceed the motor threshold for eliciting a muscle twitch. Electromyogram (EMG)/ Nerve Conduction Velocity (NCV) measuring system will be used to measure SSEPs. | 30 to 40 minutes before intervention, 30 to 40 minutes after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change Systolic Blood Pressure | Systolic Blood pressure will be recorded before and after each tsDCS session. | 60 to 90 minutes before intervention, 60 to 90 minutes after intervention |
| Change in Diastolic Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Radha Korupolu, MD | The University of Texas 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 |
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2 enrolled participants were not assigned to an arm--one of these participant had leg edema that interfered with outcome assessment, and the second participant did not exhibit an H reflex due to a baclofen medication pump; therefore, these 2 participants were not randomized and did not start any intervention.
We recruited 15 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anode, Then Cathode, Then Anode, Then Sham, Then Cathode tsDCS | 5 transcutaneous spinal direct current stimulation (tsDCS) sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
| FG001 | Sham, Then Cathode, Then Anode, Then Anode, Then Cathode tsDCS | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
| FG002 | Anode, Then Cathode, Then Sham, Then Anode, Then Cathode tsDCS | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
| FG003 | Cathode, Then Anode, Then Cathode, Then Anode, Then Sham tsDCS | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
| FG004 | Anode, Then Anode, Then Sham, Then Cathode, Then Cathode tsDCS | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
| FG005 | Sham, Then Anode, Then Cathode, Then Cathode, Then Anode tsDCS | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
| FG006 | Cathode, Then Anode, Then Cathode, Then Sham, Then Anode tsDCS | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
| FG007 | Sham, Then Anode, Then Cathode, Then Anode, Then Cathode tsDCS | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
| FG008 | Cathode, Then Cathode, Then Sham, Then Anode, Then Anode tsDCS | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
| FG009 | Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
| FG010 | Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent Change in Hmax | Immediately before application of tsDCS and after application of tsDCS, Hmax will be obtained from soleus muscle by stimulation of tibial nerve. The H-reflex is a compound muscle action potential elicited by low-threshold electrical stimulation of afferent fibers in the mixed nerve with subsequent monosynaptic excitation of alpha motoneurons. Changes in the excitability of the reflex pathway are estimated by measuring the amplitude of the reflex. | Those who completed the study were analyzed. Data are reported per session. There were potentially 22 cathode, 22 anode, and 11 sham sessions. Data for the Right Lower Extremity were not collected for 3 cathode, 3 anode, and 2 sham sessions, and data for the Left Lower Extremity were not collected for 3 cathode, 1 anode, and 2 sham sessions. | Posted | Mean | Standard Deviation | percent change in Hmax | 10 minutes before intervention, 10 minutes after intervention | sessions | sessions |
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5 weeks
The urinary tract infection (UTI) was unrelated to the intervention--this subject developed a UTI after randomization and completion of one anodal stimulation session.
Bruising was related to outcome measure collection (that is, related to preparation for measurement of h-reflex, which involves cleaning of the skin and placing electrodes) but unrelated to the intervention--this subject withdrew after randomization and completion of one session of sham stimulation.
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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 | Cathodal tsDCS | Each subject will be assigned to receive two cathodal tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions. Cathodal tsDCS: During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Small sample size. We did not control for timing of oral anti-spasticity medications during different trials which can effect H reflex measurement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Radha Korupolu, MD, MS | The University of Texas Health Science Center at Houston | 713-797-6976 | Radha.Korupolu@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 | Aug 18, 2017 | Oct 21, 2019 | Prot_SAP_000.pdf |
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Crossover design with 9 arms: Anodal tsDCS, Cathodal tsDCS, Sham tsDCS
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| Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS | Experimental | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
|
| Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS | Experimental | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
|
| Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS | Experimental | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
|
| Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS | Experimental | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
|
| Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS | Experimental | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
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| Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS | Experimental | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
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| Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS | Experimental | 5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session. |
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| Cathodal tsDCS | Device | During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level. |
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| Sham tsDCS | Device | During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes. |
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Diastolic Blood pressure will be recorded before and after delivering each intervention
| 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention) |
| Change in Heart Rate | Heart rate will be recorded before and after delivering each intervention | 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention) |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | kilograms |
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| Employment Status | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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Each subject will be assigned to receive two cathodal tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions. Cathodal tsDCS: During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level. |
| OG001 | Anodal tsDCS | Each subject will be assigned to receive two anodal tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions. Anodal tsDCS: During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level. |
| OG002 | Sham tsDCS | Each subject will be assigned to receive one sham tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions. Sham tsDCS: During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes. |
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| Primary | Change in Somatosensory Evoked Potential (SSEP) | A somatosensory evoked potential (SSEP) is the electrical activity response measured at the skin's surface along ascending sensory pathway following controlled peripheral nerve stimulation by tsDCS. For recording posterior tibial nerve SSEPs, the nerve is stimulated at the ankle, with the cathode midway between the Achilles tendon and the medial malleolus and the anode 3 cm distal to the cathode. Nerve stimulation should consist of a 0.1-0.2 ms duration square wave pulse at 3-5 Hertz (Hz). These pulses will be delivered by constant voltage stimulator applied transcutaneously over the targeted nerve. The stimulation intensity would exceed the motor threshold for eliciting a muscle twitch. Electromyogram (EMG)/ Nerve Conduction Velocity (NCV) measuring system will be used to measure SSEPs. | Data was not collected for this outcome measure. | Posted | 30 to 40 minutes before intervention, 30 to 40 minutes after intervention |
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| Secondary | Change Systolic Blood Pressure | Systolic Blood pressure will be recorded before and after each tsDCS session. | Those who completed the study were analyzed. Data are reported per session. After randomization, there were potentially 22 cathode sessions, 22 anode sessions, and 11 sham sessions--of these sessions, data were not collected for 2 cathode sessions, 3 anode sessions, and 2 sham sessions. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | 60 to 90 minutes before intervention, 60 to 90 minutes after intervention | sessions | sessions |
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| Secondary | Change in Diastolic Blood Pressure | Diastolic Blood pressure will be recorded before and after delivering each intervention | Those who completed the study were analyzed. Data are reported per session. After randomization, there were potentially 22 cathode sessions, 22 anode sessions, and 11 sham sessions--of these sessions, data were not collected for 2 cathode sessions, 3 anode sessions, and 2 sham sessions. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention) | sessions | sessions |
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| Secondary | Change in Heart Rate | Heart rate will be recorded before and after delivering each intervention | Those who completed the study were analyzed. Data are reported per session. After randomization, there were potentially 22 cathode sessions, 22 anode sessions, and 11 sham sessions--of these sessions, data were not collected for 2 cathode sessions, 3 anode sessions, and 2 sham sessions. | Posted | Mean | Standard Deviation | beats per minute (bpm) | 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention) | sessions | sessions |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Anodal tsDCS | Each subject will be assigned to receive two anodal tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions. Anodal tsDCS: During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level. | 0 | 15 | 1 | 15 | 0 | 15 |
| EG002 | Sham tsDCS | Each subject will be assigned to receive one sham tsDCS interventions randomly. There will be at least 1 week washout period between any 2 sessions. Sham tsDCS: During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes. | 0 | 15 | 0 | 15 | 1 | 15 |
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