Trial Outcomes & Findings for Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury (NCT NCT03249454)
NCT ID: NCT03249454
Last Updated: 2020-02-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
10 minutes before intervention, 10 minutes after intervention
Results posted on
2020-02-13
Participant Flow
We recruited 15 subjects.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
2
|
1
|
1
|
2
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
First Intervention (1 Day)
|
1
|
1
|
2
|
1
|
1
|
2
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Washout (1 Week)
|
1
|
1
|
2
|
1
|
1
|
2
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Second Intervention (1 Day)
|
1
|
1
|
2
|
1
|
1
|
2
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Third Intervention (1 Day)
|
1
|
1
|
2
|
1
|
1
|
2
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Fourth Intervention (1 Day)
|
1
|
1
|
2
|
1
|
1
|
2
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Fifth Intervention (1 Day)
|
1
|
1
|
2
|
1
|
1
|
2
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
1
|
2
|
1
|
1
|
2
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
All Participants
n=15 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.
|
|---|---|
|
Age, Continuous
|
37.40 Years
STANDARD_DEVIATION 13.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
|
Height
|
173.05 centimeters
STANDARD_DEVIATION 7.90 • n=5 Participants
|
|
Weight
|
76.69 kilograms
STANDARD_DEVIATION 16.92 • n=5 Participants
|
|
Employment Status
Employed
|
3 Participants
n=5 Participants
|
|
Employment Status
Unemployed
|
11 Participants
n=5 Participants
|
|
Employment Status
Student
|
1 Participants
n=5 Participants
|
|
Marital Status
Single
|
7 Participants
n=5 Participants
|
|
Marital Status
Engaged
|
1 Participants
n=5 Participants
|
|
Marital Status
Married
|
5 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 minutes before intervention, 10 minutes after interventionPopulation: 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.
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.
Outcome measures
| Measure |
Cathodal tsDCS
n=19 sessions
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.
|
Anodal tsDCS
n=21 sessions
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.
|
Sham tsDCS
n=9 sessions
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.
|
|---|---|---|---|
|
Percent Change in Hmax
Right Lower Extremity
|
27.85 percent change in Hmax
Standard Deviation 63.57
|
8.43 percent change in Hmax
Standard Deviation 29.21
|
-4.91 percent change in Hmax
Standard Deviation 39.12
|
|
Percent Change in Hmax
Left Lower Extremity
|
16.20 percent change in Hmax
Standard Deviation 55.37
|
-3.99 percent change in Hmax
Standard Deviation 23.04
|
34.04 percent change in Hmax
Standard Deviation 94.72
|
PRIMARY outcome
Timeframe: 30 to 40 minutes before intervention, 30 to 40 minutes after interventionPopulation: Data was not collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 to 90 minutes before intervention, 60 to 90 minutes after interventionPopulation: 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.
Systolic Blood pressure will be recorded before and after each tsDCS session.
Outcome measures
| Measure |
Cathodal tsDCS
n=20 sessions
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.
|
Anodal tsDCS
n=19 sessions
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.
|
Sham tsDCS
n=9 sessions
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.
|
|---|---|---|---|
|
Change Systolic Blood Pressure
|
7.90 millimeters of mercury (mmHg)
Standard Deviation 13.31
|
7.58 millimeters of mercury (mmHg)
Standard Deviation 10.37
|
-4.00 millimeters of mercury (mmHg)
Standard Deviation 6.68
|
SECONDARY outcome
Timeframe: 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)Population: 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.
Diastolic Blood pressure will be recorded before and after delivering each intervention
Outcome measures
| Measure |
Cathodal tsDCS
n=20 sessions
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.
|
Anodal tsDCS
n=19 sessions
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.
|
Sham tsDCS
n=9 sessions
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.
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure
|
4.80 millimeters of mercury (mmHg)
Standard Deviation 15.07
|
2.16 millimeters of mercury (mmHg)
Standard Deviation 6.65
|
-0.44 millimeters of mercury (mmHg)
Standard Deviation 9.06
|
SECONDARY outcome
Timeframe: 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)Population: 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.
Heart rate will be recorded before and after delivering each intervention
Outcome measures
| Measure |
Cathodal tsDCS
n=20 sessions
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.
|
Anodal tsDCS
n=19 sessions
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.
|
Sham tsDCS
n=9 sessions
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.
|
|---|---|---|---|
|
Change in Heart Rate
|
-7.35 beats per minute (bpm)
Standard Deviation 5.28
|
-6.53 beats per minute (bpm)
Standard Deviation 6.99
|
-4.78 beats per minute (bpm)
Standard Deviation 5.63
|
Adverse Events
Cathodal tsDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anodal tsDCS
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tsDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cathodal tsDCS
n=15 participants at risk
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.
|
Anodal tsDCS
n=15 participants at risk
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.
|
Sham tsDCS
n=15 participants at risk
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.
|
|---|---|---|---|
|
Renal and urinary disorders
Hospitalization for Urinary Tract Infection
|
0.00%
0/15 • 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.
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/15 • 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.
|
Other adverse events
| Measure |
Cathodal tsDCS
n=15 participants at risk
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.
|
Anodal tsDCS
n=15 participants at risk
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.
|
Sham tsDCS
n=15 participants at risk
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.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/15 • 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.
|
0.00%
0/15 • 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.
|
6.7%
1/15 • Number of events 1 • 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.
|
Additional Information
Radha Korupolu, MD, MS
The University of Texas Health Science Center at Houston
Phone: 713-797-6976
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place