Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury
1 other identifier
interventional
15
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2017
CompletedStudy Start
First participant enrolled
August 11, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2018
CompletedResults Posted
Study results publicly available
February 13, 2020
CompletedFebruary 13, 2020
January 1, 2020
1.2 years
August 2, 2017
October 23, 2019
January 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
Change Systolic Blood Pressure
60 to 90 minutes before intervention, 60 to 90 minutes after intervention
Change in Diastolic Blood Pressure
60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)
Change in Heart Rate
60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)
Study Arms (11)
Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS
EXPERIMENTAL5 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
EXPERIMENTAL5 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
EXPERIMENTAL5 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
EXPERIMENTAL5 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
EXPERIMENTAL5 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
EXPERIMENTAL5 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
EXPERIMENTAL5 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
EXPERIMENTAL5 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
EXPERIMENTAL5 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
EXPERIMENTAL5 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
EXPERIMENTAL5 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.
Interventions
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.
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.
During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
Eligibility Criteria
You may qualify if:
- Providing written informed consent prior to any study related procedures
- 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)
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Limitations and Caveats
Small sample size. We did not control for timing of oral anti-spasticity medications during different trials which can effect H reflex measurement.
Results Point of Contact
- Title
- Radha Korupolu, MD, MS
- Organization
- The University of Texas Health Science Center at Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Radha Korupolu, MD
The University of Texas Health Science Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 2, 2017
First Posted
August 15, 2017
Study Start
August 11, 2017
Primary Completion
October 26, 2018
Study Completion
October 26, 2018
Last Updated
February 13, 2020
Results First Posted
February 13, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share