Spinal Cord InjuriesNCT05801536
TCES for Upper Limb Function in Cervical SCI
A study testing SCONE in people with Spinal Cord Injuries, run by University of Leeds at 1 site in United Kingdom.
Trial summary
Following a cervical spinal cord injury (cSCI; damage to the spinal cord at the neck) there is catastrophic loss of hand and grip function. This has a devastating effect on quality of life and functional independence. Thus, there is a real need to identify and optimise therapy to aid functional arm and hand recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- SCONE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2022to 1 May 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cervical (between C3 and C7) spinal cord injury at least 1 year prior to the study.
- Between 18 and 80 years of age.
- Difficulty with hand functions in activities of daily living (e.g. dressing, grooming, feeding)
- Stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities.
- Capable of performing simple cued motor tasks such as reaching and touching or grasping objects.
- Ability to attend 3 sessions of weekly experimental sessions and testing activities over the course of 8 weeks.
- Ability to provide informed consent (either verbally or in writing).
- Ability to read/speak English.
Who cannot join
- History of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.
- Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).
- Rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.).
- Active cancer
- Cardiovascular or pulmonary disease that would prevent full participation in the upper limb practice intervention
- Ongoing medical complications (such as unhealed fracture, contracture, pressure sore, or urinary tract infection or other illnesses) that might interfere with upper extremity rehabilitation or testing activities
Show all 17Show fewer
- Any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
- Personal or familial history of epilepsy
- Pregnancy
- Botulinum toxin injections in the prior 6 months
- Dependent on ventilation support
- Implanted stimulator (e.g. vagus nerve stimulator, pacemaker, cochlear implant, etc) 0r infusion device (e.g. insulin pump, etc).
- Cardiac pacemaker or intracardial lines. Exclusions for general safety
- Pregnancy
- Alcohol and/or drug abuse.
- Unable to read and/or comprehend the consent form.
- Unable to understand the instructions given as part of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
Official title: The Effects of Transcutaneous Electrical Stimulation on Arm Functions in Individuals With Cervical Spinal Cord Injury.
Following a cervical spinal cord injury (cSCI; damage to the spinal cord at the neck) there is catastrophic loss of hand and grip function. This has a devastating effect on quality of life and functional independence. Thus, there is a real need to identify and optimise therapy to aid functional arm and hand recovery. One such therapy is Transcutaneous Electrical Stimulation (tCES). This involves applying sticky pads to the skin and then transmitting a low-level electrical current to the spinal cord. This activates neural circuits, allowing injured nerves to transmit signals to muscles to produce movement while completing upper limb tasks. The purpose of this pilot project is to establish if and how tCES might be used to improve arm and hand control. The investigators will recruit 8 people who have had a cSCI for >1yr. First, the investigators will invite volunteers to the University for 2 weeks, twice per week, to establish their baseline movement capacity.
Then the investigators will allocate the volunteers to one of two groups: group 1 will undertake 4 weeks of upper limb task practice (ULTP) followed by 4 weeks of ULTP+tCES; group 2 will undertake ULTP+tCES for 4 weeks followed by 4 weeks of ULTP. Participants will then complete a week (2 sessions) of post-intervention assessment. The investigators will then invite volunteers and carers to be interviewed about their experiences of being involved in the project. Finally, there will be 2 sessions of follow-up assessment after 3 months. In order to assess if and how ULTP+tCES affects arm and hand control the investigators will measure: movement capacity using standard clinical tests; muscular activity in response to brain/spinal stimulation; how fast and smooth movements are when reaching and grasping objects. The investigators will also examine how the intervention has affected Quality of Life (QoL) and independence (Spinal Cord Independence Measure).
Read the detailed description
Spinal cord injury (SCI) can be defined as a loss of communication between the brain and the body due to damage to pathways within the spinal cord. Injury to the cervical levels of the spinal cord are more common than injury to the lower segments of the spinal cord, thus tetraplegia is more common than paraplegia (Thompson et al., 2014). Tetraplegics rank regaining arm and hand function as their main priority for rehabilitation, five times greater than bowel, bladder, sexual or lower extremity function (Anderson, 2004). However, compared to recent advances made in recovery of ambulatory function, research that strives to uncover how best to optimise arm/hand rehabilitation after SCI is very limited. Thus identifying and optimising efficacious therapies to restore functional arm and hand recovery is an important clinical, economic and social goal.
While promising molecular strategies have emerged to reduce secondary injury and promote axonal regrowth, an effective cure eludes people with cervical SCI, and overall recovery of arm and hand function using these means remains limited (Levi et al., 2018). Functional training, or task specific training of a motor function (e.g. reaching and grasping), is currently the most effective evidence-based way of enhancing plasticity to recover motor function. A promising approach is the use of stimulation-based rehabilitative therapies promoting neural plasticity along the spinal cord/corticospinal tract. Among these, transcutaneous electrical stimulation (TCES) (Gerasimenko et al., 2015) was demonstrated to be effective for improving hand grip strength in people with spinal cord injury (Gad et al., 2018). The investigators hypothesise that combining upper limb practice (ULTP) and TCES to the cervical spinal cord over the course of 4 weeks, could affect arm/ hand function and quality of life to a greater extent than ULTP by itself.
The principal aim of the study is to test the effects of transcutaneous electrical stimulation on arm and hand functions in individuals with cervical spinal cord injury. In addition, the investigators aim to assess the neurophysiological mechanisms with which transcutaneous electrical stimulation supports the observed changes in hand/arm function.
The primary objective of the study is to measure and compare the changes in hand and arm functions, assessed through the Graded and Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP) tool, occurring over the course of the two interventions (ULTP and ULTP + TCES). In addition, secondary objectives are:
To explain the neurophysiological mechanisms with which transcutaneous electrical stimulation results in changes in hand/arm function.
To establish a clearly defined, reproducible protocol for establishing participant specific TCES settings.
To understand factors that contribute to participants wanting to use TCES and their experience of using TCES.
The study will consist of two weeks of baseline measurements, 8 weeks of intervention (4 weeks of ULTP and 4 weeks of TCES + ULTP) in a cross-over design, followed by two-weekly and a 3 month follow-up with no further intervention (Inanici et al., 2018). The baseline measurements (see primary and secondary outcome measures) are necessary to document stability of functional status. Baseline measures will take place over 2 sessions, each week (e.g. 4 baseline testing sessions).
Participation to the study will span over the course of 25 weeks. On the first 2 weeks, participants will attend the lab twice per week. On the following 8 weeks, participants will attend the lab three times per week. On week 11, participants will attend the lab twice. On week 12, participants and their carers will be invited to a semi-structured interview. There will then be a 3-months break during which the participants are not required to attend the lab, after which (week 25) they will take part on two follow-up sessions.
- Conditions
- Spinal Cord Injuries
- Being tested
- SCONE
- Keywords
- transcutaneous electrical stimulation, cervical, upper limbs
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCONEDevice
This is a noninvasive (nonsurgical) electrical neuromodulation device to reactivate and retrain the neurons and neural networks in the spinal cord to improve function after neurological trauma. The device will be used to stimulate the cervical spinal cord as participants practice tasks involving upper limb control.
| Study group | Role | What they receive |
|---|---|---|
| Upper limb task practice with or without cervical transcutaneous electrical stimulation | Experimental | Task specific practice will be combined with cervical transcutaneous electrical stimulation. Receives: Device: SCONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
GRASSP
Graded and Redefined Assessment of Strength, Sensibility and Prehension test. The primary objective of the study is to measure and compare the changes in hand and arm functions, assessed through the Graded and Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP) tool, occurring over the course of the two interventions (ULTP and ULTP + TCES).
Measured: 17 months
Secondary outcomes (9)
Kinematics movement time
The time (seconds) taken to complete the reach to grasp tasks
Measured: 17 months
Kinematics peak velocity
The maximum velocity (m/s) value observed during the reach to grasp tasks
Measured: 17 months
Surface Electromyography (sEMG) amplitude
The root mean square amplitude (rms) of EMG signals during unimanual and bimanual standardised reach to grasp actions will be monitored.
Measured: 17 months
Surface Electromyography (sEMG) frequency
The frequency (Hz) of EMG signals during unimanual and bimanual standardised reach to grasp actions will be monitored.
Measured: 17 months
Spinal-evoked potentials
Upon electrical stimulation at the cervical level spinally evoked potentials in forearm muscles including biceps brachii (biceps), triceps brachii (triceps), extensor carpi radialis (ECR), flexor carpi radialis (FCR) and abductor pollicis brevis (APB) will be investigated.
Measured: 17 months
Motor Evoked Potentials
Motor-evoked potentials recorded from the dominant (APB) muscle induced via transcranial magnetic stimulation will be monitored.
Measured: 17 months
Monosynaptic reflex
Evoked upon median nerve stimulation in FCR and APB muscles.
Measured: 17 months
Spinal Cord Independence Measure (SCIM) questionnaire score
Measures independence across 3 sub-domains. Range 0 to 100 with 100 indicating better independence
Measured: 17 months
Quality of Life (QoL) questionnaire score.
Measures quality of life according to measures of satisfaction and importance across multiple domains. Scale 1-6 with 6 indicating more satisfied or more important
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start13 Jun 2022
- Primary completion1 May 2024
- Study completion1 May 2024
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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- International Spinal Research Trust
- Responsible party
- Principal investigator, Professor Sarah Astill, University of Leeds
- Investigators
- Sarah Astill, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801536
- Sponsor's protocol ID
- NMN007
- Status last verified
- Jun 2024
- First submitted
- 16 Mar 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcutaneous Electrical Stimulation on Arm Functions in Individuals With Cervical Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT05801536
- Acronym / sponsor ID
- NMN007
- Conditions
- Spinal Cord Injuries
- Keywords
- transcutaneous electrical stimulation, cervical, upper limbs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- International Spinal Research Trust
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 6 Apr 2023 (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.
Following a cervical spinal cord injury (cSCI; damage to the spinal cord at the neck) there is catastrophic loss of hand and grip function. This has a devastating effect on quality of life and functional independence. Thus, there is a real need to identify and optimise therapy to aid functional arm and hand recovery. One such therapy is Transcutaneous Electrical Stimulation (tCES). This involves applying sticky pads to the skin and then transmitting a low-level electrical current to the spinal cord. This activates neural circuits, allowing injured nerves to transmit signals to muscles to produce movement while completing upper limb tasks. The purpose of this pilot project is to establish if and how tCES might be used to improve arm and hand control. The investigators will recruit 8 people who have had a cSCI for >1yr. First, the investigators will invite volunteers to the University for 2 weeks, twice per week, to establish their baseline movement capacity.
Then the investigators will allocate the volunteers to one of two groups: group 1 will undertake 4 weeks of upper limb task practice (ULTP) followed by 4 weeks of ULTP+tCES; group 2 will undertake ULTP+tCES for 4 weeks followed by 4 weeks of ULTP. Participants will then complete a week (2 sessions) of post-intervention assessment. The investigators will then invite volunteers and carers to be interviewed about their experiences of being involved in the project. Finally, there will be 2 sessions of follow-up assessment after 3 months. In order to assess if and how ULTP+tCES affects arm and hand control the investigators will measure: movement capacity using standard clinical tests; muscular activity in response to brain/spinal stimulation; how fast and smooth movements are when reaching and grasping objects. The investigators will also examine how the intervention has affected Quality of Life (QoL) and independence (Spinal Cord Independence Measure).
Detailed description
Spinal cord injury (SCI) can be defined as a loss of communication between the brain and the body due to damage to pathways within the spinal cord. Injury to the cervical levels of the spinal cord are more common than injury to the lower segments of the spinal cord, thus tetraplegia is more common than paraplegia (Thompson et al., 2014). Tetraplegics rank regaining arm and hand function as their main priority for rehabilitation, five times greater than bowel, bladder, sexual or lower extremity function (Anderson, 2004). However, compared to recent advances made in recovery of ambulatory function, research that strives to uncover how best to optimise arm/hand rehabilitation after SCI is very limited. Thus identifying and optimising efficacious therapies to restore functional arm and hand recovery is an important clinical, economic and social goal.
While promising molecular strategies have emerged to reduce secondary injury and promote axonal regrowth, an effective cure eludes people with cervical SCI, and overall recovery of arm and hand function using these means remains limited (Levi et al., 2018). Functional training, or task specific training of a motor function (e.g. reaching and grasping), is currently the most effective evidence-based way of enhancing plasticity to recover motor function. A promising approach is the use of stimulation-based rehabilitative therapies promoting neural plasticity along the spinal cord/corticospinal tract. Among these, transcutaneous electrical stimulation (TCES) (Gerasimenko et al., 2015) was demonstrated to be effective for improving hand grip strength in people with spinal cord injury (Gad et al., 2018). The investigators hypothesise that combining upper limb practice (ULTP) and TCES to the cervical spinal cord over the course of 4 weeks, could affect arm/ hand function and quality of life to a greater extent than ULTP by itself.
The principal aim of the study is to test the effects of transcutaneous electrical stimulation on arm and hand functions in individuals with cervical spinal cord injury. In addition, the investigators aim to assess the neurophysiological mechanisms with which transcutaneous electrical stimulation supports the observed changes in hand/arm function.
The primary objective of the study is to measure and compare the changes in hand and arm functions, assessed through the Graded and Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP) tool, occurring over the course of the two interventions (ULTP and ULTP + TCES). In addition, secondary objectives are:
To explain the neurophysiological mechanisms with which transcutaneous electrical stimulation results in changes in hand/arm function.
To establish a clearly defined, reproducible protocol for establishing participant specific TCES settings.
To understand factors that contribute to participants wanting to use TCES and their experience of using TCES.
The study will consist of two weeks of baseline measurements, 8 weeks of intervention (4 weeks of ULTP and 4 weeks of TCES + ULTP) in a cross-over design, followed by two-weekly and a 3 month follow-up with no further intervention (Inanici et al., 2018). The baseline measurements (see primary and secondary outcome measures) are necessary to document stability of functional status. Baseline measures will take place over 2 sessions, each week (e.g. 4 baseline testing sessions).
Participation to the study will span over the course of 25 weeks. On the first 2 weeks, participants will attend the lab twice per week. On the following 8 weeks, participants will attend the lab three times per week. On week 11, participants will attend the lab twice. On week 12, participants and their carers will be invited to a semi-structured interview. There will then be a 3-months break during which the participants are not required to attend the lab, after which (week 25) they will take part on two follow-up sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper limb task practice with or without cervical transcutaneous electrical stimulation | Experimental | Device: SCONETask specific practice will be combined with cervical transcutaneous electrical stimulation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cervical (between C3 and C7) spinal cord injury at least 1 year prior to the study.
- Between 18 and 80 years of age.
- Difficulty with hand functions in activities of daily living (e.g. dressing, grooming, feeding)
- Stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities.
- Capable of performing simple cued motor tasks such as reaching and touching or grasping objects.
Key exclusion criteria (17 listed)
- History of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.
- Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).
- Rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.).
- Active cancer
- Cardiovascular or pulmonary disease that would prevent full participation in the upper limb practice intervention
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 |
|---|---|---|
| SCONEThis is a noninvasive (nonsurgical) electrical neuromodulation device to reactivate and retrain the neurons and neural networks in the spinal cord to improve function after neurological trauma. The device will be used to stimulate the cervical spinal cord as participants practice tasks involving upper limb control. | Device | Upper limb task practice with or without cervical transcutaneous electrical stimulation |
Primary outcome
GRASSP
Time frame: 17 months
Graded and Redefined Assessment of Strength, Sensibility and Prehension test. The primary objective of the study is to measure and compare the changes in hand and arm functions, assessed through the Graded and Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP) tool, occurring over the course of the two interventions (ULTP and ULTP + TCES).
9 secondary outcomes
Kinematics movement time
Time frame: 17 months
Kinematics peak velocity
Time frame: 17 months
Surface Electromyography (sEMG) amplitude
Time frame: 17 months
Surface Electromyography (sEMG) frequency
Time frame: 17 months
Spinal-evoked potentials
Time frame: 17 months
Motor Evoked Potentials
Time frame: 17 months
Monosynaptic reflex
Time frame: 17 months
Spinal Cord Independence Measure (SCIM) questionnaire score
Time frame: 17 months
Quality of Life (QoL) questionnaire score.
Time frame: 17 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 20 Jun 2024.
- 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.
Sarah Astill, PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCONE in people with Spinal Cord Injuries, run by University of Leeds at 1 site in United Kingdom.
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 8 inclusion and 17 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 20 Jun 2024. 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 Kingdom. 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?
GRASSP (time frame: 17 months). 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 20 Jun 2024.