Traumatic Brain InjuryNCT04183998
Restorative Neuromodulation for Upper Extremity Functions
A study testing Trans-spinal Electrical Stimulation (tsES) in people with Traumatic Brain Injury and Cervical Spinal Cord Injury, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The objective of this research study is to find the efficacy of trans-spinal electrical stimulation, a non-invasive neurostimulation method to modulate the functions of spinal cord neurocircuits, on improving upper-extremity functions such as reaching and grasping in individuals suffering with traumatic brain injury… Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Cervical Spinal Cord Injury
- What is being tested?
- Trans-spinal Electrical Stimulation (tsES)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2019to 31 Jan 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least one year post-injury
- Non-progressive TBI or SCI at above C7 spinal level
- Unable to grip or reach independently, and requires assistance for daily living activities
- Spinal reflexes remain functional below the lesion
- Female participants of child-bearing potential must be on a standard method of contraception and must not be pregnant
Who cannot join
- Cardiopulmonary disease or dysfunction, high blood pressure or other medical risk factors
- Received Botox injection in the prior 6 months
- Cervical fusion with any metal which may interfere with trans-spinal electric currents
- Other electronic implants such as cardiac pacemakers, defibrillators, shunts, stents etc.
- Unhealed fracture, contracture, pressure sore, or infections
- Currently receiving treatments for either 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 to Restore Upper Extremity Functions in Individuals With Traumatic Brain Injury (TBI) or Spinal Cord Injury (SCI).
The objective of this research study is to find the efficacy of trans-spinal electrical stimulation, a non-invasive neurostimulation method to modulate the functions of spinal cord neurocircuits, on improving upper-extremity functions such as reaching and grasping in individuals suffering with traumatic brain injury (TBI) or cervical spinal cord injury (SCI); and to find the physiological changes in the neuromuscular systems after this new intervention with high-resolution electrophysiology and biomedical imaging.
Read the detailed description
Spinal cord is composed of specialized neural networks, capable of executing different functions. Although the command for upper-limb functions such as reaching and grasping is delivered from the brain, the cervical spinal cord circuits work as an important hub for not only executing the task, but also amplify the command and maintain the dynamics with proper feedback mechanisms with it's reflex circuitry. A simple reaching and grasping function requires spatiotemporal coordination of upper-limb joints and the neuromuscular systems, their adaptation and control in gravity. For human, these physiological activities are well choreographed by sets of neural networks. In combination with afferent sensory 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 traumatic brain injury (TBI) or cervical spinal cord injury (SCI), upper-limb motor tasks maybe enabled by directly activating these specialized cervical cord networks via external stimuli. Recent studies have demonstrated that neuromodulation via spinal cord stimulation can effectively restore upper-limb motor function in patients with chronic neurological injuries.
Traumatic injuries to the central nervous system (CNS) such as TBI and SCI are 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, three recent groundbreaking pilot 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 well understood, and thus it is a challenge to be convinced with the efficacy of this new therapy. A deeper understanding of the physiology in a larger trial of two different but related neurological patient groups, proposed in this study, will significantly help the researcher to prove the efficacy and understand the mechanism of trans-spinal electrical stimulation therapy for the patients. This study will further assist the researchers to design even a better therapeutic intervention for neurological impaired patients.
- Being tested
- Trans-spinal Electrical Stimulation (tsES)
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-spinal Electrical Stimulation (tsES)Other
Stimulation will be achieved with two self-adhesive stimulation electrodes attached to the dorsal aspect of the neck overlying the cervical vertebrae and two self-adhesive rectangular return electrodes placed over the shoulders. Spinal motor evoked potentials (sMEP) induced by trans-spinal electrical stimulation (parameters, 1 Hz with a 0.1-1 ms pulse width and monophasic waveform) to determine recruitment profiles of proximal and distal motor pools with increasing stimulation intensity ranging from 10 to 200 milliampere. Stimulation parameters for the therapeutic stimulation will be ranged from 5-40 Hz and 20-100 milliampere.
| Study group | Role | What they receive |
|---|---|---|
| tsES | Experimental | trans-spinal Electrical Stimulation (tsES) Receives: Other: Trans-spinal Electrical Stimulation (tsES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment
Fugl-Meyer Assessment for upper extremity will be used for the measurement of upper limb motor functional recovery. We will adobe the version of the University of Gothenburg approved by Fugl-Meyer AR. In a cumulative numerical scoring to evaluate the physical performance including coordination and speed of the upper extremities, functions of hand and wrist will be assessed separately. The test is constructed with different stages of motor recovery: 1) reflexes reoccur; 2) stereotyped volitional movement can be imitated within flexor and extensor synergies; 3) movements can be performed that deviate from primitive synergies; and 4) reflexes are normalized. A 3-point ordinal scale will be applied to each item: 0=the detail cannot be performed, 1=the detail can be partially performed; 2=the detail can be fully performed. The maximum motor score for the upper extremity can be 66 points where higher score will indicate better function.
Measured: 12 months
Modified Ashworth Scale
Modified Ashworth Scale is a measurement tool for muscle tone which can be used to measure upper-limb spasticity at different upper extremity segments. It is a 6-point numerical scoring system: 0=no increase in muscle tone, 1=slight increase in muscle tone; 1+=slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder; 2=more marked increase in muscle tone through most of the ROM, but affected part move easily; 3=considerable increase in muscle tone, passive movement difficult; 4=affected part rigid. Lower scores after the treatment will indicate the decrease of muscle spasticity around the specific upper extremity joints, on contrary, higher scores will indicated the aggravation of the muscle spasticity of the segment.The test will be carried out before and after each of the three experimental phases (Phase 1-3).
Measured: 12 months
Action Research Arm Test
Action Research Arm Test is also a cumulative numerical rating scale for the measurement of upper extremity performance,which is frequently used in research and clinical practice. The reliability of this test has been evaluated in several studies using reliability coefficients such as Spearman's rank correlation coefficient and intra-class correlation coefficient. This test focuses more on the hand functions with 4 basic movements: grasp, grip, pinch and gross movement, and is assessed on a 4-category ordinal scale (i.e., 0,1,2, and 3) with totally 19 items.The ordinal scale is not only related to the degree of completion of an action, but also related to the time cost:0=the motion task cannot be performed, 1=the motion task can be partially performed, 2=the motion task can be fully performed, but clunky or slow, 3=the motion task can be fully performed normally.
Measured: 12 months
Wolf Motor Function Test
The Wolf Motor Function Test is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks. The Wolf Motor Function Test has been posited as instructive for assessing the motor status of higher functioning chronic patients with stroke and traumatic brain injury, in terms of severity and upper extremity motor deficiency.It has 17 items and is assessed with two scoring systems: 1) a 5-category ordinal scale where higher scores mean better motor function; 2) time counting scale where higher scores mean slower movement and worse motor function.Grip force has also been concluded in this test.
Measured: 12
Secondary outcomes (1)
Functional Independence Measurement
In addition to assessing patients' post-injury functional status, the Functional Independence Measure will also be monitored once a month and in follow-up. The Functional Independence Measure is an 18-items,7-level questionnaire assessment designed to evaluate the amount of assistance required by the disabled individual to perform basic life activities safely and effectively.
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 posted3 Dec 2019
- Study start1 May 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- NCT04183998
- Sponsor's protocol ID
- HSEARS20190121002
- Status last verified
- Mar 2022
- First submitted
- 17 Nov 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: On request and under condition.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-spinal Electrical Stimulation to Restore Upper Extremity Functions in Individuals With Traumatic Brain Injury (TBI) or Spinal Cord Injury (SCI).
- ClinicalTrials.gov ID
- NCT04183998
- Acronym / sponsor ID
- HSEARS20190121002
- 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 May 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 3 Dec 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 objective of this research study is to find the efficacy of trans-spinal electrical stimulation, a non-invasive neurostimulation method to modulate the functions of spinal cord neurocircuits, on improving upper-extremity functions such as reaching and grasping in individuals suffering with traumatic brain injury (TBI) or cervical spinal cord injury (SCI); and to find the physiological changes in the neuromuscular systems after this new intervention with high-resolution electrophysiology and biomedical imaging.
Detailed description
Spinal cord is composed of specialized neural networks, capable of executing different functions. Although the command for upper-limb functions such as reaching and grasping is delivered from the brain, the cervical spinal cord circuits work as an important hub for not only executing the task, but also amplify the command and maintain the dynamics with proper feedback mechanisms with it's reflex circuitry. A simple reaching and grasping function requires spatiotemporal coordination of upper-limb joints and the neuromuscular systems, their adaptation and control in gravity. For human, these physiological activities are well choreographed by sets of neural networks. In combination with afferent sensory 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 traumatic brain injury (TBI) or cervical spinal cord injury (SCI), upper-limb motor tasks maybe enabled by directly activating these specialized cervical cord networks via external stimuli. Recent studies have demonstrated that neuromodulation via spinal cord stimulation can effectively restore upper-limb motor function in patients with chronic neurological injuries.
Traumatic injuries to the central nervous system (CNS) such as TBI and SCI are 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, three recent groundbreaking pilot 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 well understood, and thus it is a challenge to be convinced with the efficacy of this new therapy. A deeper understanding of the physiology in a larger trial of two different but related neurological patient groups, proposed in this study, will significantly help the researcher to prove the efficacy and understand the mechanism of trans-spinal electrical stimulation therapy for the patients. This study will further assist the researchers to design even a better therapeutic intervention for neurological impaired patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tsES | Experimental | Other: Trans-spinal Electrical Stimulation (tsES)trans-spinal Electrical Stimulation (tsES) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least one year post-injury
- Non-progressive TBI or SCI at above C7 spinal level
- Unable to grip or reach independently, and requires assistance for daily living activities
- Spinal reflexes remain functional below the lesion
- Female participants of child-bearing potential must be on a standard method of contraception and must not be pregnant
Key exclusion criteria (6 listed)
- Cardiopulmonary disease or dysfunction, high blood pressure or other medical risk factors
- Received Botox injection in the prior 6 months
- Cervical fusion with any metal which may interfere with trans-spinal electric currents
- Other electronic implants such as cardiac pacemakers, defibrillators, shunts, stents etc.
- Unhealed fracture, contracture, pressure sore, or infections
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)Stimulation will be achieved with two self-adhesive stimulation electrodes attached to the dorsal aspect of the neck overlying the cervical vertebrae and two self-adhesive rectangular return electrodes placed over the shoulders. Spinal motor evoked potentials (sMEP) induced by trans-spinal electrical stimulation (parameters, 1 Hz with a 0.1-1 ms pulse width and monophasic waveform) to determine recruitment profiles of proximal and distal motor pools with increasing stimulation intensity ranging from 10 to 200 milliampere. Stimulation parameters for the therapeutic stimulation will be ranged from 5-40 Hz and 20-100 milliampere. | Other | tsES |
Primary outcome
Fugl-Meyer Assessment
Time frame: 12 months
Fugl-Meyer Assessment for upper extremity will be used for the measurement of upper limb motor functional recovery. We will adobe the version of the University of Gothenburg approved by Fugl-Meyer AR. In a cumulative numerical scoring to evaluate the physical performance including coordination and speed of the upper extremities, functions of hand and wrist will be assessed separately. The test is constructed with different stages of motor recovery: 1) reflexes reoccur; 2) stereotyped volitional movement can be imitated within flexor and extensor synergies; 3) movements can be performed that deviate from primitive synergies; and 4) reflexes are normalized. A 3-point ordinal scale will be applied to each item: 0=the detail cannot be performed, 1=the detail can be partially performed; 2=the detail can be fully performed. The maximum motor score for the upper extremity can be 66 points where higher score will indicate better function.
Modified Ashworth Scale
Time frame: 12 months
Modified Ashworth Scale is a measurement tool for muscle tone which can be used to measure upper-limb spasticity at different upper extremity segments. It is a 6-point numerical scoring system: 0=no increase in muscle tone, 1=slight increase in muscle tone; 1+=slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder; 2=more marked increase in muscle tone through most of the ROM, but affected part move easily; 3=considerable increase in muscle tone, passive movement difficult; 4=affected part rigid. Lower scores after the treatment will indicate the decrease of muscle spasticity around the specific upper extremity joints, on contrary, higher scores will indicated the aggravation of the muscle spasticity of the segment.The test will be carried out before and after each of the three experimental phases (Phase 1-3).
Action Research Arm Test
Time frame: 12 months
Action Research Arm Test is also a cumulative numerical rating scale for the measurement of upper extremity performance,which is frequently used in research and clinical practice. The reliability of this test has been evaluated in several studies using reliability coefficients such as Spearman's rank correlation coefficient and intra-class correlation coefficient. This test focuses more on the hand functions with 4 basic movements: grasp, grip, pinch and gross movement, and is assessed on a 4-category ordinal scale (i.e., 0,1,2, and 3) with totally 19 items.The ordinal scale is not only related to the degree of completion of an action, but also related to the time cost:0=the motion task cannot be performed, 1=the motion task can be partially performed, 2=the motion task can be fully performed, but clunky or slow, 3=the motion task can be fully performed normally.
Wolf Motor Function Test
Time frame: 12
The Wolf Motor Function Test is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks. The Wolf Motor Function Test has been posited as instructive for assessing the motor status of higher functioning chronic patients with stroke and traumatic brain injury, in terms of severity and upper extremity motor deficiency.It has 17 items and is assessed with two scoring systems: 1) a 5-category ordinal scale where higher scores mean better motor function; 2) time counting scale where higher scores mean slower movement and worse motor function.Grip force has also been concluded in this test.
1 secondary outcome
Functional Independence Measurement
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 29 Mar 2022.
- Individual participant dataSharing planned: Undecided. On request and under condition.
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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 Traumatic Brain Injury and Cervical Spinal Cord Injury, 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 29 Mar 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?
Fugl-Meyer Assessment (time frame: 12 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 29 Mar 2022.