Spinal Cord InjuriesPhase 2NCT04041063
Rehabilitation and Cortical Remodeling After Surgical Intervention for Spinal Cord Injury
A Phase 2 study testing Upper limb robotic training and Nerve transfer surgery in people with Spinal Cord Injuries and Tetraplegia, run by Burke Medical Research Institute at 1 site in United States.
Trial summary
The aim of this study is to determine the effects of rehabilitation on dexterous hand movements and cortical motor map changes in tetraplegic patients following nerve transfer surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Spinal Cord Injuries, Tetraplegia, Cervical Spinal Cord Injury
- What is being tested?
- Upper limb robotic training and Nerve transfer surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2019to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Tetraplegia (cervical lesion) with some degree of motor dysfunction in the hand
- Motor incomplete or complete lesion (measured by the ASIA Impairment Scale, A, B, C, D).
- Chronic lesion (at least 6months after the injury)
- Demonstrate stability of motor examination for at least six months.
- Retain intact innervation within paralyzed target muscles (axon recipient) as determined by electrodiagnostics.
- Have muscles innervated by the nerves to be used for the transfers (axon donors) of MRC grade 4/5 or greater and sufficient innervation as determined by electrodiagnostics.
- Have access to an at home caregiver who can assist with customary postsurgical physical therapy.
- Ability to give informed consent and understand the tasks involved.
Who cannot join
- Presence of potential risk factor for brain stimulation: history of seizures, presence of surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull.
- History of head trauma and/or cognitive deficit
- Medically unstable
- Contraindicated for nerve transfer surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Neurological Institute
White Plains, New York, 10605
About this study
The aim of this study is to determine the effects of rehabilitation on dexterous hand movements and cortical motor map changes in tetraplegic patients following nerve transfer surgery. The working hypothesis is that robot-assisted, intensive rehabilitation will support the return of hand and arm function and strengthen the cortical representations of targeted muscles. The investigators will assess this through TMS mapping and clinical measures of hand and arm function.
Read the detailed description
The recovery of hand and arm function is of critical importance for decreasing long-term care costs and increasing quality of life for individuals with tetraplegia due to spinal cord injury (SCI). A subset of these individuals, with injuries in the mid to low cervical spinal cord, are candidates for nerve transfer surgery. Nerve transfer surgery restores function after SCI through coaptation of redundant, intact donor nerves to recipient nerves arising at or below the level of SCI. The use of nerve transfer after SCI is relatively novel and many patients exhibit a remarkable recovery of hand and arm motor function in the months that follow, however others show a much more limited recovery. The extent of recovery is likely limited, in part, by variability in rehabilitation and the ability of the motor cortex to incorporate the new peripheral circuitry resulting from this surgical procedure. There is a critical need to determine the response of cortical motor networks to nerve transfer and the role that rehabilitation plays in supporting cortical plasticity and motor recovery. If this need is not met, incomplete recovery from this state-of-the-art surgical intervention will persist and the potential application to a wider patient population will not be realized.
The investigators will test the central hypothesis that nerve transfer surgery after cervical SCI creates a novel cortical motor network, which can support the return of dexterous hand/forelimb function through rehabilitation-dependent remodeling. The hypothesis has been based upon 1) previous work in an animal model showing that rehabilitation reshapes cortical motor maps, 2) the pioneering work of a handful of clinicians, including the study collaborator, Justin Brown, that have applied nerve transfer to bypass spinal levels affected by injury, and 3) recent work using transcranial magnetic stimulation (TMS) in human SCI to map the cortical representation of arm muscles in the zone of partial preservation, and the ability to improve hand-arm function through intensive robotic training in chronically impaired subjects. The use of TMS to map cortical motor networks will allow the investigators to measure the cortical reorganization resulting from nerve transfer and determine the extent to which rehabilitation can engage this alternative cortical motor network. The rationale for the proposed studies is that a determination of the mechanisms that support rehabilitation-mediated recovery after nerve transfer will be required for optimizing and refining current clinical practice.
- Being tested
- Upper limb robotic training, Nerve transfer surgery
- Keywords
- robotics, hand function
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper limb robotic trainingDevice
Subjects will remain seated in their own wheelchair in front of the InMotion Hand™ Robot (Interactive Motion Technologies, Massachusetts, MA, Figure 6) facing a video screen.
The arm of the participants will be abducted, forearm supported, and hand grasping a cone shaped handle. Velcro straps will lightly hold the forearm and fingers secure. The InMotion Hand™ robot attaches to the InMotion Arm™ robots to provide 'assisted-as-needed'™ gross grasp and release motion and support for functional reach. In each session, patients perform a total of 1024 movement repetitions (Cortes et al., 2013). Patients will receive a total of 18 sessions (3x/week, 6 weeks) comprising one hour of interactive hand robotic training. The interactive robotic features involve visuomotor task, moving the robotic manipulandum according to targets on a computer screen mounted at eye level.
Nerve transfer surgeryProcedure or surgery
C5 injury; Teres minor branch of axillary nerve transferred to long head of triceps branch of radial nerve (RN); Brachialis branch of musculocutaneous nerve to anterior interosseous nerve (AIN); Supinator branch of RN to posterior interosseous nerve (PIN). C6 injury; Teres minor branch of axillary nerve to long head of triceps branch of RN; Extensor carpi radialis brevis (ECRB) branch of RN to AIN; Supinator branch of RN to PIN. C7 injury with preserved triceps, loss of grasp/release; Pronator teres branch of median nerve to AIN; Terminal branch of ECRB branch of RN to flexor pollicis longus branch of AIN; Supinator branch of RN transferred to PIN. C7 injury with preserved triceps/finger extension, loss of grasp; Pronator teres branch of median nerve to AIN; Terminal branch of ECRB branch of RN to flexor pollicis longus branch of AIN.
| Study group | Role | What they receive |
|---|---|---|
| Nerve transfer + robotic training | Experimental | Participants will receive nerve transfer surgery at Massachusetts General Hospital in Boston, MA. One year after the surgery, participants will receive six weeks of upper limb robotic training at the Burke Neurological Institute in White Plains, NY. Receives: Device: Upper limb robotic training; Procedure: Nerve transfer surgery |
| Nerve transfer + delayed robotic training | Active comparator | Participants will receive nerve transfer surgery at Massachusetts General Hospital in Boston, MA. One year + six weeks after the surgery, participants will receive six weeks of upper limb robotic training at the Burke Neurological Institute in White Plains, NY. Receives: Device: Upper limb robotic training; Procedure: Nerve transfer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Box and Blocks test score
The Box and Blocks test measures how many blocks a person can grasp and transfer in one minute. A higher score is associated with better hand function.
Measured: 1 year post surgery, immediately post training, minus baseline before surgery
Secondary outcomes (4)
Upper extremity motor score (UEMS)
The Upper extremity motor score (UEMS) tests the clinical motor strength from 0 to 5 from each key muscle using the ASIA scale. This sum score ranges from 0 (paralyzed) to 25 (normal) in each limb.
Measured: 1 year post surgery, immediately post training, minus baseline before surgery
Spinal Cord Independence Measure (SCIM III)
The Spinal Cord Independence Measure (SCIM III) measures the ability of patients with SCI to perform everyday tasks according to their value for the patient. SCIM is used for quantitative functional outcome assessment following interventions designed to promote recovery from spinal cord injury and to increase functional achievement; and it covers 19 tasks in 16 categories (score range 0-100); all activities of daily living, grouped into four areas of function (subscales): Self-Care (scored 0-20), Respiration and Sphincter Management (0-40), Mobility in Room and Toilet (0-10), Mobility Indoors and Outdoors (0-30).
Measured: 1 year post surgery, immediately post training, minus baseline before surgery
Modified Ashworth Scale
The Modified Ashworth Scale (MAS) will be used to measure change in spasticity. The scale is a scale from 0 to 4 that measures muscle stiffness. A higher score is associated with greater spasticity.
Measured: 1 year post surgery, immediately post training, minus baseline before surgery
Single pulse transcranial magnetic stimulation
Changes in resting motor threshold (RMT), motor evoked potential (MEP) amplitude will be measured in each muscle of both arms using a MagStim X100 stimulator (MagStim) and a figure-8 coil. We will investigate the neurophysiological correlates of function, and the characteristics of participants who respond better to the training.
Measured: 1 year post surgery, immediately post training, minus baseline before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start26 Jul 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will receive nerve transfer surgery. Half of the participants will receive 6 weeks of robotic training starting one year after the surgery. The other half of the participants will receive 6 weeks of robotic training starting one year plus 6 weeks after the nerve transfer surgery.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burke Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041063
- Sponsor's protocol ID
- SCI_nerve_transfer_robotics
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2019
- Last updated
- 23 Aug 2024
- Results posted
- No
- 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation and Cortical Remodeling After Surgical Intervention for Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04041063
- Acronym / sponsor ID
- SCI_nerve_transfer_robotics
- Keywords
- robotics, hand function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Burke Medical Research InstituteUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Aug 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 aim of this study is to determine the effects of rehabilitation on dexterous hand movements and cortical motor map changes in tetraplegic patients following nerve transfer surgery. The working hypothesis is that robot-assisted, intensive rehabilitation will support the return of hand and arm function and strengthen the cortical representations of targeted muscles. The investigators will assess this through TMS mapping and clinical measures of hand and arm function.
Detailed description
The recovery of hand and arm function is of critical importance for decreasing long-term care costs and increasing quality of life for individuals with tetraplegia due to spinal cord injury (SCI). A subset of these individuals, with injuries in the mid to low cervical spinal cord, are candidates for nerve transfer surgery. Nerve transfer surgery restores function after SCI through coaptation of redundant, intact donor nerves to recipient nerves arising at or below the level of SCI. The use of nerve transfer after SCI is relatively novel and many patients exhibit a remarkable recovery of hand and arm motor function in the months that follow, however others show a much more limited recovery. The extent of recovery is likely limited, in part, by variability in rehabilitation and the ability of the motor cortex to incorporate the new peripheral circuitry resulting from this surgical procedure. There is a critical need to determine the response of cortical motor networks to nerve transfer and the role that rehabilitation plays in supporting cortical plasticity and motor recovery. If this need is not met, incomplete recovery from this state-of-the-art surgical intervention will persist and the potential application to a wider patient population will not be realized.
The investigators will test the central hypothesis that nerve transfer surgery after cervical SCI creates a novel cortical motor network, which can support the return of dexterous hand/forelimb function through rehabilitation-dependent remodeling. The hypothesis has been based upon 1) previous work in an animal model showing that rehabilitation reshapes cortical motor maps, 2) the pioneering work of a handful of clinicians, including the study collaborator, Justin Brown, that have applied nerve transfer to bypass spinal levels affected by injury, and 3) recent work using transcranial magnetic stimulation (TMS) in human SCI to map the cortical representation of arm muscles in the zone of partial preservation, and the ability to improve hand-arm function through intensive robotic training in chronically impaired subjects. The use of TMS to map cortical motor networks will allow the investigators to measure the cortical reorganization resulting from nerve transfer and determine the extent to which rehabilitation can engage this alternative cortical motor network. The rationale for the proposed studies is that a determination of the mechanisms that support rehabilitation-mediated recovery after nerve transfer will be required for optimizing and refining current clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will receive nerve transfer surgery. Half of the participants will receive 6 weeks of robotic training starting one year after the surgery. The other half of the participants will receive 6 weeks of robotic training starting one year plus 6 weeks after the nerve transfer surgery.
| Arm | Type | Receives |
|---|---|---|
| Nerve transfer + robotic training | Experimental | Device: Upper limb robotic training, Procedure: Nerve transfer surgeryParticipants will receive nerve transfer surgery at Massachusetts General Hospital in Boston, MA. One year after the surgery, participants will receive six weeks of upper limb robotic training at the Burke Neurological Institute in White Plains, NY. |
| Nerve transfer + delayed robotic training | Active comparator | Device: Upper limb robotic training, Procedure: Nerve transfer surgeryParticipants will receive nerve transfer surgery at Massachusetts General Hospital in Boston, MA. One year + six weeks after the surgery, participants will receive six weeks of upper limb robotic training at the Burke Neurological Institute in White Plains, NY. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Tetraplegia (cervical lesion) with some degree of motor dysfunction in the hand
- Motor incomplete or complete lesion (measured by the ASIA Impairment Scale, A, B, C, D).
- Chronic lesion (at least 6months after the injury)
- Demonstrate stability of motor examination for at least six months.
- Retain intact innervation within paralyzed target muscles (axon recipient) as determined by electrodiagnostics.
Key exclusion criteria (4 listed)
- Presence of potential risk factor for brain stimulation: history of seizures, presence of surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull.
- History of head trauma and/or cognitive deficit
- Medically unstable
- Contraindicated for nerve transfer surgery.
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 |
|---|---|---|
| Upper limb robotic trainingSubjects will remain seated in their own wheelchair in front of the InMotion Hand™ Robot (Interactive Motion Technologies, Massachusetts, MA, Figure 6) facing a video screen. The arm of the participants will be abducted, forearm supported, and hand grasping a cone shaped handle. Velcro straps will lightly hold the forearm and fingers secure. The InMotion Hand™ robot attaches to the InMotion Arm™ robots to provide 'assisted-as-needed'™ gross grasp and release motion and support for functional reach. In each session, patients perform a total of 1024 movement repetitions (Cortes et al., 2013). Patients will receive a total of 18 sessions (3x/week, 6 weeks) comprising one hour of interactive hand robotic training. The interactive robotic features involve visuomotor task, moving the robotic manipulandum according to targets on a computer screen mounted at eye level. | Device | Nerve transfer + delayed robotic training, Nerve transfer + robotic training |
| Nerve transfer surgeryC5 injury; Teres minor branch of axillary nerve transferred to long head of triceps branch of radial nerve (RN); Brachialis branch of musculocutaneous nerve to anterior interosseous nerve (AIN); Supinator branch of RN to posterior interosseous nerve (PIN). C6 injury; Teres minor branch of axillary nerve to long head of triceps branch of RN; Extensor carpi radialis brevis (ECRB) branch of RN to AIN; Supinator branch of RN to PIN. C7 injury with preserved triceps, loss of grasp/release; Pronator teres branch of median nerve to AIN; Terminal branch of ECRB branch of RN to flexor pollicis longus branch of AIN; Supinator branch of RN transferred to PIN. C7 injury with preserved triceps/finger extension, loss of grasp; Pronator teres branch of median nerve to AIN; Terminal branch of ECRB branch of RN to flexor pollicis longus branch of AIN. | Procedure or surgery | Nerve transfer + delayed robotic training, Nerve transfer + robotic training |
Primary outcome
Change in Box and Blocks test score
Time frame: 1 year post surgery, immediately post training, minus baseline before surgery
The Box and Blocks test measures how many blocks a person can grasp and transfer in one minute. A higher score is associated with better hand function.
4 secondary outcomes
Upper extremity motor score (UEMS)
Time frame: 1 year post surgery, immediately post training, minus baseline before surgery
Spinal Cord Independence Measure (SCIM III)
Time frame: 1 year post surgery, immediately post training, minus baseline before surgery
Modified Ashworth Scale
Time frame: 1 year post surgery, immediately post training, minus baseline before surgery
Single pulse transcranial magnetic stimulation
Time frame: 1 year post surgery, immediately post training, minus baseline before surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Upper limb robotic training and Nerve transfer surgery in people with Spinal Cord Injuries and Tetraplegia, run by Burke Medical Research Institute 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 8 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 23 Aug 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in Box and Blocks test score (time frame: 1 year post surgery, immediately post training, minus baseline before surgery). 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 23 Aug 2024.