Incomplete Spinal Cord InjuryNCT03249454
Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury
A study testing Anodal tsDCS and Cathodal tsDCS in people with Incomplete Spinal Cord Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Incomplete Spinal Cord Injury
- What is being tested?
- Anodal tsDCS and Cathodal tsDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2017to 26 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Providing written informed consent prior to any study related procedures
- 18-65 years of age
- Motor incomplete SCI classified as B, C or D by the American Spinal Injury Association Impairment Scale (AIS)
- Traumatic lesion at or above T8-T9 neurological level
- Body mass index ≤ 30 (in order to facilitate reliable location of body landmarks guiding stimulation);
- Chronic SCI (time since injury>6 months)
Who cannot join
- Unstable cardiopulmonary conditions
- History of seizure, head injury with loss of consciousness, severe alcohol or drug abuse, and/or psychiatric illness
- Any joint contracture or severe spasticity, as measured by a Modified Ashworth Score 4
- Subject who cannot provide self-transportation to the study location
- Cardiac or neural pacemakers
- Pregnancy
Show all 13Show fewer
- lower motor neuron injury (eg: peripheral neuropathy, cauda equina syndrome)
- Uncontrolled diabetes with HbA1C>7
- History of severe autonomic dysreflexia
- No planned alteration in therapy or medication for muscle tone during the course of the study(No botulinum toxin injections in last 3 months, No phenol injections in last 6 months, intrathecal baclofen pump dose stable for past 3 months, etc)
- Conditions for e.g., severe arthritis, extreme shoulder pain that would interfere with valid administration of the measures or with interpreting motor testing;
- No contraindications to tsDCS
- ferromagnetic material in the brain or in the spine (except for titanium used in segmental)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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).
Read the detailed description
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.
- Conditions
- Incomplete Spinal Cord Injury
- Being tested
- Anodal tsDCS, Cathodal tsDCS, Sham tsDCS
- Keywords
- Incomplete SCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tsDCSDevice
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.
Cathodal tsDCSDevice
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.
Sham tsDCSDevice
During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Anodal tsDCS; Device: Cathodal tsDCS; Device: Sham tsDCS |
| 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. Receives: Device: Anodal tsDCS; Device: Cathodal tsDCS; Device: Sham tsDCS |
| 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. Receives: Device: Anodal tsDCS; Device: Cathodal tsDCS; Device: Sham tsDCS |
| 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. Receives: Device: Anodal tsDCS; Device: Cathodal tsDCS; Device: Sham tsDCS |
| 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. Receives: Device: Anodal tsDCS; Device: Cathodal tsDCS; Device: Sham tsDCS |
| 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. Receives: Device: Anodal tsDCS; Device: Cathodal tsDCS; Device: Sham tsDCS |
| 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. Receives: Device: Anodal tsDCS; Device: Cathodal tsDCS; Device: Sham tsDCS |
| 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. Receives: Device: Anodal tsDCS; Device: Cathodal tsDCS; Device: Sham tsDCS |
| 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. Receives: Device: Anodal tsDCS; Device: Cathodal tsDCS; Device: Sham tsDCS |
| 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. Receives: Device: Anodal tsDCS; Device: Cathodal tsDCS; Device: Sham tsDCS |
| 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. Receives: Device: Anodal tsDCS; Device: Cathodal tsDCS; Device: Sham tsDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 to 40 minutes before intervention, 30 to 40 minutes after intervention
Secondary outcomes (3)
Change Systolic Blood Pressure
Systolic Blood pressure will be recorded before and after each tsDCS session.
Measured: 60 to 90 minutes before intervention, 60 to 90 minutes after intervention
Change in Diastolic Blood Pressure
Diastolic Blood pressure will be recorded before and after delivering each intervention
Measured: 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
Measured: 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start11 Aug 2017
- Primary completion26 Oct 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Incomplete Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover design with 9 arms: Anodal tsDCS, Cathodal tsDCS, Sham tsDCS
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- TIRR/Mission Connect
- Responsible party
- Principal investigator, Radha Korupolu, The University of Texas Health Science Center, Houston
- Investigators
- Radha Korupolu, MD, Principal investigator, The University of Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249454
- Sponsor's protocol ID
- HSC-MS-17-0166
- Status last verified
- Jan 2020
- First submitted
- 2 Aug 2017
- Last updated
- 13 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03249454
- Acronym / sponsor ID
- HSC-MS-17-0166
- Conditions
- Incomplete Spinal Cord Injury
- Keywords
- Incomplete SCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- TIRR/Mission Connect
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Posted 13 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 11
- Model description
- Crossover design with 9 arms: Anodal tsDCS, Cathodal tsDCS, Sham tsDCS
| Arm | Type | Receives |
|---|---|---|
| Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS | Experimental | Device: Anodal tsDCS, Device: Cathodal tsDCS, Device: Sham tsDCS5 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 | Experimental | Device: Anodal tsDCS, Device: Cathodal tsDCS, Device: Sham tsDCS5 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 | Experimental | Device: Anodal tsDCS, Device: Cathodal tsDCS, Device: Sham tsDCS5 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 | Experimental | Device: Anodal tsDCS, Device: Cathodal tsDCS, Device: Sham tsDCS5 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 | Experimental | Device: Anodal tsDCS, Device: Cathodal tsDCS, Device: Sham tsDCS5 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 | Device: Anodal tsDCS, Device: Cathodal tsDCS, Device: Sham tsDCS5 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 | Device: Anodal tsDCS, Device: Cathodal tsDCS, Device: Sham tsDCS5 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 | Device: Anodal tsDCS, Device: Cathodal tsDCS, Device: Sham tsDCS5 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 | Device: Anodal tsDCS, Device: Cathodal tsDCS, Device: Sham tsDCS5 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 | Experimental | Device: Anodal tsDCS, Device: Cathodal tsDCS, Device: Sham tsDCS5 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 | Experimental | Device: Anodal tsDCS, Device: Cathodal tsDCS, Device: Sham tsDCS5 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Providing written informed consent prior to any study related procedures
- 18-65 years of age
- Motor incomplete SCI classified as B, C or D by the American Spinal Injury Association Impairment Scale (AIS)
- Traumatic lesion at or above T8-T9 neurological level
- Body mass index ≤ 30 (in order to facilitate reliable location of body landmarks guiding stimulation);
Key exclusion criteria (13 listed)
- Unstable cardiopulmonary conditions
- History of seizure, head injury with loss of consciousness, severe alcohol or drug abuse, and/or psychiatric illness
- Any joint contracture or severe spasticity, as measured by a Modified Ashworth Score 4
- Subject who cannot provide self-transportation to the study location
- Cardiac or neural pacemakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal tsDCSDuring 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. | Device | Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS, Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS, Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS, Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS, Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS, Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS, Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS, Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS, Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS, Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS, Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS |
| Cathodal tsDCSDuring 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. | Device | Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS, Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS, Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS, Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS, Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS, Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS, Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS, Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS, Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS, Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS, Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS |
| Sham tsDCSDuring Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes. | Device | Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS, Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS, Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS, Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS, Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS, Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS, Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS, Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS, Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS, Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS, Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS |
Primary outcome
Percent Change in Hmax
Time frame: 10 minutes before intervention, 10 minutes after intervention
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.
Change in Somatosensory Evoked Potential (SSEP)
Time frame: 30 to 40 minutes before intervention, 30 to 40 minutes after intervention
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.
3 secondary outcomes
Change Systolic Blood Pressure
Time frame: 60 to 90 minutes before intervention, 60 to 90 minutes after intervention
Change in Diastolic Blood Pressure
Time frame: 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)
Change in Heart Rate
Time frame: 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radha Korupolu, MD principal investigator
The University of Texas Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tsDCS and Cathodal tsDCS in people with Incomplete Spinal Cord Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Hmax (time frame: 10 minutes before intervention, 10 minutes after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.