Spinal Cord InjuriesNCT04171375
Restorative Neuromodulation for Lower Extremity Functions
A study testing trans-spinal Electrical Stimulation (tsES) in people with Spinal Cord Injuries and Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The overall objective of the proposed study is to restore lower-extremity functions of paraplegic individuals. Paralysis following Stroke or spinal cord injury (SCI) result harsh sufferings including lifelong dependence on wheelchairs and thus often life threatening conditions such as pressure sore resulted from the… Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Stroke, Paralysis
- What is being tested?
- trans-spinal Electrical Stimulation (tsES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2019to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be at least one year post-injury and not dependent on ventilation support
- Lower-extremity paralyzed and half of key muscles below neurological level having a motor score of less than 2/5
- Female subjects must be on standard contraception method and must not be pregnant throughout the study
- Segmental reflexes are functional below the lesion
- Ability to exercises 1-2 hours per day and commit for 1 year training program
Who cannot join
- Cardiopulmonary disease or dysfunction, high blood pressure or other condition which contraindicate participation in lower extremity rehabilitation exercise
- Received of Botox injections in the prior 6 months
- Weakened bone, unhealed fracture, contracture, pressure sore, or infection that might interfere with the exercise
- Thoracic or lumbar fusion with any metal which may interfere with electric currents
- Other electronic implants such as cardiac pacemaker, defibrillator, shunt, stent etc.
- Currently receiving treatments for pain management or spasticity or depression.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Biomedical Engineering, The Hong Kong Polytechnic University
Kowloon
About this study
Official title: Trans-spinal Electrical Stimulation Along With Locomotor Training to Restore Walking in Paraplegic Patients
The overall objective of the proposed study is to restore lower-extremity functions of paraplegic individuals. Paralysis following Stroke or spinal cord injury (SCI) result harsh sufferings including lifelong dependence on wheelchairs and thus often life threatening conditions such as pressure sore resulted from the immobility. Recently, electrical stimulation targeting the lumbosacral spinal cord has shown activation of spinal circuits that control standing and walking functions; while body-weight supported locomotor training has shown overall health improvement of the paraplegic patients through activity dependent rehabilitation. In the current project we aim to combine the trans-spinal electrical stimulation and locomotor training in an efficient, cost-effective and simplified manner for functional rehabilitation. In this proposed study, Stroke and SCI paraplegics will be regularly trained to stand and walk on a body-weight support system with the aid of lower-limb orthoses and trans-spinal electrical stimulation. In progressive weeks the orthotic support of the lower-limb would be slowly lifted off and only the stimulation therapy will be delivered during the locomotor training. Repetitive training with this combination therapy, the spinal pathways would likely reorganize and would promote long-term rehabilitation of the lower-extremity. After successful demonstration of this in our laboratory settings, we aim to transform this technology for community use.
Read the detailed description
Spinal cord is composed of specialized neural networks, capable of executing different functions. Although the command for lower-limb functions such as standing and walking is primarily delivered from the brain, it was found that the spinal cord circuits not only execute it but also maintain the task and control the dynamics with proper feedback mechanisms with it's reflex circuitry. Simple bipedal standing and walking requires spatiotemporal coordination of muscles, limb joints, balance etc., their adaptation and control in gravity. For human, these physiological activities are well choreographed by sets of neural networks. In combination with afferent proprioceptive inputs, these network circuits work with the motor periphery to generate a series of motor acts during each task. Normally, the activity of these spinal networks are regulated supraspinally and by peripheral sensory inputs. In case of the loss of supraspinal inputs, resultant of a Stroke or spinal cord injury (SCI), motor tasks maybe enabled by directly activating these specialized spinal cord networks via external stimuli. Recent studies have demonstrated that neuromodulation via spinal cord stimulation can effectively restore lower-extremity functions in patients with chronic neurological injuries.
Traumatic injury to the central nervous system (CNS) such as SCI is devastating events leaving patients with impairment of motor, sensory and autonomic functions. Mainstay for the treatment is still limited to rehabilitation by physical therapy and training. In few patients, however, neuroplasticity and repair mechanisms are considered to contribute to recovery of paresis in the acute stage of the injury and stops in the chronic stage. But, recent groundbreaking studies have shown that the recovery can be further amplified in the chronic stage by the novel treatment of trans-spinal electrical stimulation. However, the rehabilitation related to this recovery is not very significant, and thus it is a challenge to be convinced with the efficacy of this new therapy. A combination therapy of trans-spinal electrical stimulation along with body-weight would promote better recovery and benefit the patients more. The current study will further assist the researchers to design such combinational therapeutic intervention for neurologically impaired patients to stimulate to walk again. Successful translation of this novel technology would facilitate the paraplegic community to become more healthy, independent and happy.
- Conditions
- Spinal Cord Injuries, Stroke, Paralysis
- Being tested
- trans-spinal Electrical Stimulation (tsES)
- Medical subject headings
- Spinal Cord Injuries, Stroke, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans-spinal Electrical Stimulation (tsES)Device
The trans-spinal pulsed-current stimulation utilizes non-invasive russian stimulation using a research grade stimulator and direct-current stimulation utilizes non-invasive constant stimulation using a medical grade stimulator. Both pulsed- and direct-current stimulation will be achieved with cutaneous cathode electrodes attached to the dorsal aspect of the back overlying at and bellow thoracic vertebrae and anode electrodes placed over the iliac crests or lower abdomen. Spinal motor evoked potentials will be induced by trans-spinal pulsed-current stimulation (parameters, 1 Hz with a 1 millisecond pulse width and monophasic waveform) to determine recruitment profiles of proximal and distal motor pools with increasing stimulation intensity ranging from 10-200 milliampere. Stimulation parameters for the therapeutic stimulation will be ranged from 5-50 Hz and 20-200 milliampere. For direct-current stimulation, the stimulation current will be kept constant at 2-2.5 milliampere.
| Study group | Role | What they receive |
|---|---|---|
| trans-spinal Electrical Stimulation (tsES) | Experimental | Not described Receives: Device: trans-spinal Electrical Stimulation (tsES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Spinal Injury Association Impairment Scale
An experienced physiotherapist will assess the patient at baseline and every month until the end of the study. The physiotherapist will use the American Spinal Injury Association Impairment Scale, a maximum possible score is 112 points to evaluate the sensation and muscle strengths of the patient. In particular, the examinations will involve manual muscle testing (with grades 0 to 5*; higher grades indicate stronger muscle strength), anorectal examination, as well as assessments of light touch (using a piece of cotton) and pinprick sensation (using a paper clip). All assessments will follow the myotome and dermatome. Based on the findings, an American Spinal Injury Association Impairment Scale grade will be given to indicate the severity of paralysis.
Measured: 18 months
Modified Ashworth Scale
The spasticity of the patient was evaluated by the Modified Ashworth Scale, which is a 6-point scale to assess the resistance experienced by the therapist during passive muscle stretching. Higher scores indicate greater spasticity.
Measured: 18 months
Neuromuscular Recovery Scale
The neuromuscular recovery scale will be used to quantify functionally motor tasks without compensation. It consists of 14 items/tasks (e.g., sit-to-stand, or standing). The physiotherapist will rate each item by comparing the deviations of patients' performance from the normative task performance in the movement pattern. Lower scores indicate major deviations. The maximum sum of all item scores is 161.
Measured: 18 months
Spinal Cord Independence Measure
The functional performance of the patient will be assessed by the Spinal Cord Independence Measure. This is an observational examination contains three subscales with a maximum score of 100: (1) self-care; (2) respiration and sphincter; and (3) mobility. The self-care subscale includes six tasks (with a score ranging from 0 to 20). The respiration and sphincter subscale includes four tasks (with a score ranging from 0 to 40). The mobility subscale (with a score ranging from 0 to 40) contains two more subscales to evaluate mobility in "room and toilet", and "indoors and outdoors, on even surface". A higher score indicates a better function.
Measured: 18 months
Secondary outcomes (1)
5-10 meter overground walking test
Tests overground walking improvements of the paraplegics.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Apr 2019
- Primary completion30 Jun 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Dr Monzurul Alam, The Hong Kong Polytechnic University
- Investigators
- Monzurul Alam, PhD, Principal investigator, Research Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171375
- Sponsor's protocol ID
- HSEARS20190201002
- Status last verified
- Jan 2022
- First submitted
- 17 Nov 2019
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-spinal Electrical Stimulation Along With Locomotor Training to Restore Walking in Paraplegic Patients
- ClinicalTrials.gov ID
- NCT04171375
- Acronym / sponsor ID
- HSEARS20190201002
- Conditions
- Spinal Cord Injuries, Stroke, Paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Hospital Authority, Hong Kong
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the proposed study is to restore lower-extremity functions of paraplegic individuals. Paralysis following Stroke or spinal cord injury (SCI) result harsh sufferings including lifelong dependence on wheelchairs and thus often life threatening conditions such as pressure sore resulted from the immobility. Recently, electrical stimulation targeting the lumbosacral spinal cord has shown activation of spinal circuits that control standing and walking functions; while body-weight supported locomotor training has shown overall health improvement of the paraplegic patients through activity dependent rehabilitation. In the current project we aim to combine the trans-spinal electrical stimulation and locomotor training in an efficient, cost-effective and simplified manner for functional rehabilitation. In this proposed study, Stroke and SCI paraplegics will be regularly trained to stand and walk on a body-weight support system with the aid of lower-limb orthoses and trans-spinal electrical stimulation. In progressive weeks the orthotic support of the lower-limb would be slowly lifted off and only the stimulation therapy will be delivered during the locomotor training. Repetitive training with this combination therapy, the spinal pathways would likely reorganize and would promote long-term rehabilitation of the lower-extremity. After successful demonstration of this in our laboratory settings, we aim to transform this technology for community use.
Detailed description
Spinal cord is composed of specialized neural networks, capable of executing different functions. Although the command for lower-limb functions such as standing and walking is primarily delivered from the brain, it was found that the spinal cord circuits not only execute it but also maintain the task and control the dynamics with proper feedback mechanisms with it's reflex circuitry. Simple bipedal standing and walking requires spatiotemporal coordination of muscles, limb joints, balance etc., their adaptation and control in gravity. For human, these physiological activities are well choreographed by sets of neural networks. In combination with afferent proprioceptive inputs, these network circuits work with the motor periphery to generate a series of motor acts during each task. Normally, the activity of these spinal networks are regulated supraspinally and by peripheral sensory inputs. In case of the loss of supraspinal inputs, resultant of a Stroke or spinal cord injury (SCI), motor tasks maybe enabled by directly activating these specialized spinal cord networks via external stimuli. Recent studies have demonstrated that neuromodulation via spinal cord stimulation can effectively restore lower-extremity functions in patients with chronic neurological injuries.
Traumatic injury to the central nervous system (CNS) such as SCI is devastating events leaving patients with impairment of motor, sensory and autonomic functions. Mainstay for the treatment is still limited to rehabilitation by physical therapy and training. In few patients, however, neuroplasticity and repair mechanisms are considered to contribute to recovery of paresis in the acute stage of the injury and stops in the chronic stage. But, recent groundbreaking studies have shown that the recovery can be further amplified in the chronic stage by the novel treatment of trans-spinal electrical stimulation. However, the rehabilitation related to this recovery is not very significant, and thus it is a challenge to be convinced with the efficacy of this new therapy. A combination therapy of trans-spinal electrical stimulation along with body-weight would promote better recovery and benefit the patients more. The current study will further assist the researchers to design such combinational therapeutic intervention for neurologically impaired patients to stimulate to walk again. Successful translation of this novel technology would facilitate the paraplegic community to become more healthy, independent and happy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trans-spinal Electrical Stimulation (tsES) | Experimental | Device: trans-spinal Electrical Stimulation (tsES) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be at least one year post-injury and not dependent on ventilation support
- Lower-extremity paralyzed and half of key muscles below neurological level having a motor score of less than 2/5
- Female subjects must be on standard contraception method and must not be pregnant throughout the study
- Segmental reflexes are functional below the lesion
- Ability to exercises 1-2 hours per day and commit for 1 year training program
Key exclusion criteria (6 listed)
- Cardiopulmonary disease or dysfunction, high blood pressure or other condition which contraindicate participation in lower extremity rehabilitation exercise
- Received of Botox injections in the prior 6 months
- Weakened bone, unhealed fracture, contracture, pressure sore, or infection that might interfere with the exercise
- Thoracic or lumbar fusion with any metal which may interfere with electric currents
- Other electronic implants such as cardiac pacemaker, defibrillator, shunt, stent etc.
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 |
|---|---|---|
| trans-spinal Electrical Stimulation (tsES)The trans-spinal pulsed-current stimulation utilizes non-invasive russian stimulation using a research grade stimulator and direct-current stimulation utilizes non-invasive constant stimulation using a medical grade stimulator. Both pulsed- and direct-current stimulation will be achieved with cutaneous cathode electrodes attached to the dorsal aspect of the back overlying at and bellow thoracic vertebrae and anode electrodes placed over the iliac crests or lower abdomen. Spinal motor evoked potentials will be induced by trans-spinal pulsed-current stimulation (parameters, 1 Hz with a 1 millisecond pulse width and monophasic waveform) to determine recruitment profiles of proximal and distal motor pools with increasing stimulation intensity ranging from 10-200 milliampere. Stimulation parameters for the therapeutic stimulation will be ranged from 5-50 Hz and 20-200 milliampere. For direct-current stimulation, the stimulation current will be kept constant at 2-2.5 milliampere. | Device | trans-spinal Electrical Stimulation (tsES) |
Primary outcome
American Spinal Injury Association Impairment Scale
Time frame: 18 months
An experienced physiotherapist will assess the patient at baseline and every month until the end of the study. The physiotherapist will use the American Spinal Injury Association Impairment Scale, a maximum possible score is 112 points to evaluate the sensation and muscle strengths of the patient. In particular, the examinations will involve manual muscle testing (with grades 0 to 5*; higher grades indicate stronger muscle strength), anorectal examination, as well as assessments of light touch (using a piece of cotton) and pinprick sensation (using a paper clip). All assessments will follow the myotome and dermatome. Based on the findings, an American Spinal Injury Association Impairment Scale grade will be given to indicate the severity of paralysis.
Modified Ashworth Scale
Time frame: 18 months
The spasticity of the patient was evaluated by the Modified Ashworth Scale, which is a 6-point scale to assess the resistance experienced by the therapist during passive muscle stretching. Higher scores indicate greater spasticity.
Neuromuscular Recovery Scale
Time frame: 18 months
The neuromuscular recovery scale will be used to quantify functionally motor tasks without compensation. It consists of 14 items/tasks (e.g., sit-to-stand, or standing). The physiotherapist will rate each item by comparing the deviations of patients' performance from the normative task performance in the movement pattern. Lower scores indicate major deviations. The maximum sum of all item scores is 161.
Spinal Cord Independence Measure
Time frame: 18 months
The functional performance of the patient will be assessed by the Spinal Cord Independence Measure. This is an observational examination contains three subscales with a maximum score of 100: (1) self-care; (2) respiration and sphincter; and (3) mobility. The self-care subscale includes six tasks (with a score ranging from 0 to 20). The respiration and sphincter subscale includes four tasks (with a score ranging from 0 to 40). The mobility subscale (with a score ranging from 0 to 40) contains two more subscales to evaluate mobility in "room and toilet", and "indoors and outdoors, on even surface". A higher score indicates a better function.
1 secondary outcome
5-10 meter overground walking test
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Monzurul Alam, PhD principal investigator
Research Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trans-spinal Electrical Stimulation (tsES) in people with Spinal Cord Injuries and Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 5 inclusion and 6 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 6 Jan 2022. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
American Spinal Injury Association Impairment Scale (time frame: 18 months). The study lists 4 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 6 Jan 2022.