Cervical Spinal Cord InjurySUReNCT06743607
Spinal Stimulation for Upper Extremity Recovery in the Home
A study testing Immediate Intervention in people with Cervical Spinal Cord Injury, run by Craig Hospital at 1 site in United States.
Trial summary
The purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and/or community in combination with a functional home exercise program for the upper extremities (arm/hand function) as well as their combined impacts on changes in upper extremity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spinal Cord Injury
- What is being tested?
- Immediate Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2025to Aug 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- History of traumatic SCI
- Less than 12 months post SCI
- SCI injury level C1-C8
- SCI categorized as AIS B-D
- Have passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows
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- Have caregiver support to attend three in-person sessions and ongoing training at home
- Have a caregiver who, in the judgment of the research team, is qualified to assist the participant in the safe use of TSS
- Able to complete in-person training sessions and return to Craig Hospital for assessments
- Experience no complicating physical or cognitive conditions as determined by their physician that would preclude the safe use of electrical stimulation
- If using prescribed anti-spasticity medications, must be at a stable dose for at least four weeks prior to starting study procedures
- Agrees to comply with investigational devices instructions for use, protocol visits, and return of the device
- Able to provide informed consent
Who cannot join
- Experience unstable chronic cardiac or respiratory complaints
- Have a recent history of fracture, contractures, or skin pressure injuries that might interfere with the intervention
- Received Botox injections to the UEs, neck, or hands within the last three months
- Pregnant, planning to become pregnant, or currently breastfeeding
- Have breakdown in skin area that will come into contact with electrodes
- Prior nerve or tendon transfer procedure for the UEs
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- Concurrently are participating in another drug or device trial that may interfere with this study
- Have an implanted pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intrathecal pump
- In the opinion of the investigators, the study is not safe or appropriate for the participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Craig Hospital
Englewood, Colorado, 80113
Candy Tefertiller, PT, DPT, PhD, NCS, 303-789-8000, ctefertiller@craighospital.org
Bria Mellick, MS, 303-789-8757, bmellick@craighospital.org
About this study
Official title: Spinal Stimulation to Improve Upper Extremity Recovery in the Home (SSTIM UE Recover [SURe])
The purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and/or community in combination with a functional home exercise program for the upper extremities (arm/hand function) as well as their combined impacts on changes in upper extremity function. The expected duration of participation in this study is about 31-33 hours over a 13-25-week period. Enrollees in this study will be randomly assigned to one of two groups: 1) upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation, or 2) waitlist control, which involves the same intervention, but with a 12-week delayed start. Participants complete initial testing (one time if in group one and three times [at weeks 0, 8, and 12] if in group two), 24 1-hour training sessions (2x/week in home with caregiver/companion support and 1x/week with research team in person or via video conference for 8 weeks), a post-treatment evaluation, and a final evaluation (4 weeks after post-treatment).
- Conditions
- Cervical Spinal Cord Injury
- Being tested
- Immediate Intervention, Waitlist control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate InterventionBehavioural
Participants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences immediately after enrollment.
Waitlist controlBehavioural
Participants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences 12 weeks after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Active comparator | For the immediate intervention group, each participant will complete the following:
* Initial baseline evaluation
* 24 training sessions (3x/week for eight weeks) of UE Functional Task Practice (FTP)+TSS (two training sessions/week will be completed in the home with caregiver/companion support; the third weekly session will be conducted via videoconference with a research therapist)
* Post-treatment evaluation (after eight weeks of training) and follow-up evaluation (four weeks after post-treatment evaluation).
* Post-treatment and follow-up assessments will be conducted over two days: assessments completed without TSS on day one and with TSS on day two. Receives: Behavioral: Immediate Intervention |
| Waitlist Control | Active comparator | The waitlist control group will participate in a protocol similar to the immediate intervention group, except:
* 12-week waiting period before starting the active intervention.
* Assessments will be completed at 0, 8, and 12 weeks before starting the active intervention to control for spontaneous recovery.
* Post-treatment evaluation (after eight weeks of training)
* Follow-up assessment (four weeks after the post-treatment evaluation). Receives: Behavioral: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capabilities of Upper Extremity Questionnaire (CUE-Q)
The CUE-Q version 2.1 measures functional limitation and perceived difficulty of performing actions with upper extremities in individuals with tetraplegia. The CUE-Q has 32 items; each scored on a 1-to-7-point scale representing self-perceived difficulty with total scores ranging from 32 to 224 (higher scores demonstrating greater UE function) and right and left scores assessed separately
Measured: Weeks 0, 8, 12, 21, and 25
Secondary outcomes (9)
Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)
This multimodal test measures sensorimotor and prehension function in three domains important in describing arm and hand function
Measured: Weeks 0, 8, 12, 21, and 25
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
The ISNCSCI is a universal classification tool for SCI based on a standardized sensory and motor exam. The ISNCSCI involves a detailed examination to determine the sensory and motor levels for both the right and left sides, the overall neurological level of the injury, and the completeness of the injury as designated by the American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS). The motor exam also results in a total Upper Extremity Motor Score (UEMS) ranging from 0 to 50, with higher scores indicative of greater UE strength.
Measured: Weeks 0, 8, 12, 21, and 25
Pinch and Grasp Force
Pinch and grasp force will be measured by the Commander Echo Console with the JTech Pinch and Hand Dynamometer to quantify finger and grasp strength.
Measured: Weeks 0, 8, 12, 21, and 25
Global Rating of Change (GRC)
The GRC assesses perceived change from an intervention. The scale is designed to quantify an individual's perceived improvement or deterioration over time. The magnitude of the change is then scored on a visual analog scale. GRC scales have been recommended for use as a core outcome measure in rehabilitation studies to improve the applicability of information from clinical trials to clinical practice.
Measured: Weeks 8, 12, 21, and 25
Satisfaction with Treatment Scale
The Satisfaction with Treatment Scale is a 6-point scale (0=strongly disagree; 5= strongly agree) used to rate satisfaction with treatment in previous intervention studies conducted in the home environment85 and will be modified specifically to address the transcutaneous spinal stimulation (TSS) intervention.
Measured: Weeks 8, 12, 21, and 25
Qualitative Questions
Participants and caregivers will be asked questions regarding their experience during the intervention, such as their likes and dislikes, notable changes or observations, and overall satisfaction with using TSS in their homes
Measured: Weeks 8 and 21
Canadian Occupational Performance Measure (COPM)
The COPM is an individualized, client-centered instrument designed to measure an individual's self-perception of physical functioning and satisfaction in the activities identified as important by the client. The COPM will directly assess the true importance of functional improvements with regard to the subject's ability to perform activities of daily living and/or to function occupationally.
Measured: Weeks 0, 8, 12, 21, and 25
International Spinal Cord Injury Quality of Life Basic Data Set (QoL-BDS) Version 2.0
This instrument measures self-reported quality of life across four domains: overall well-being, physical health, psychological health, and social life. For each domain, respondents are asked to rate their satisfaction on a 0-10 scale (0=completely dissatisfied; 10=completely satisfied).
Measured: Weeks 0, 8, 12, 21, and 25
International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) Version 3.0
This instrument identifies pain region, pain type (e.g., nociceptive, neuropathic), and treatments used to reduce pain in addition to pain intensity on a 0-10 scale (0=no pain; 10=pain as bad as you can imagine) and interference with various aspects of the respondent's life on a 0-10 scale (0=no interference; 10=extreme interference).
Measured: Weeks 0, 8, 12, 21, and 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start28 May 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spinal Cord 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Candace Tefertiller, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743607
- Sponsor's protocol ID
- 2274573-1
- Acronym
- SURe
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Stimulation to Improve Upper Extremity Recovery in the Home (SSTIM UE Recover [SURe])
- ClinicalTrials.gov ID
- NCT06743607
- Acronym / sponsor ID
- SURe / 2274573-1
- Conditions
- Cervical Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 28 May 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 Dec 2024 (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 purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and/or community in combination with a functional home exercise program for the upper extremities (arm/hand function) as well as their combined impacts on changes in upper extremity function. The expected duration of participation in this study is about 31-33 hours over a 13-25-week period. Enrollees in this study will be randomly assigned to one of two groups: 1) upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation, or 2) waitlist control, which involves the same intervention, but with a 12-week delayed start. Participants complete initial testing (one time if in group one and three times [at weeks 0, 8, and 12] if in group two), 24 1-hour training sessions (2x/week in home with caregiver/companion support and 1x/week with research team in person or via video conference for 8 weeks), a post-treatment evaluation, and a final evaluation (4 weeks after post-treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Active comparator | Behavioral: Immediate InterventionFor the immediate intervention group, each participant will complete the following: * Initial baseline evaluation * 24 training sessions (3x/week for eight weeks) of UE Functional Task Practice (FTP)+TSS (two training sessions/week will be completed in the home with caregiver/companion support; the third weekly session will be conducted via videoconference with a research therapist) * Post-treatment evaluation (after eight weeks of training) and follow-up evaluation (four weeks after post-treatment evaluation). * Post-treatment and follow-up assessments will be conducted over two days: assessments completed without TSS on day one and with TSS on day two. |
| Waitlist Control | Active comparator | Behavioral: Waitlist controlThe waitlist control group will participate in a protocol similar to the immediate intervention group, except: * 12-week waiting period before starting the active intervention. * Assessments will be completed at 0, 8, and 12 weeks before starting the active intervention to control for spontaneous recovery. * Post-treatment evaluation (after eight weeks of training) * Follow-up assessment (four weeks after the post-treatment evaluation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 or older
- History of traumatic SCI
- Less than 12 months post SCI
- SCI injury level C1-C8
- SCI categorized as AIS B-D
Key exclusion criteria (9 listed)
- Experience unstable chronic cardiac or respiratory complaints
- Have a recent history of fracture, contractures, or skin pressure injuries that might interfere with the intervention
- Received Botox injections to the UEs, neck, or hands within the last three months
- Pregnant, planning to become pregnant, or currently breastfeeding
- Have breakdown in skin area that will come into contact with electrodes
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 |
|---|---|---|
| Immediate InterventionParticipants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences immediately after enrollment. | Behavioural | Immediate Intervention |
| Waitlist controlParticipants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences 12 weeks after enrollment. | Behavioural | Waitlist Control |
Primary outcome
Capabilities of Upper Extremity Questionnaire (CUE-Q)
Time frame: Weeks 0, 8, 12, 21, and 25
The CUE-Q version 2.1 measures functional limitation and perceived difficulty of performing actions with upper extremities in individuals with tetraplegia. The CUE-Q has 32 items; each scored on a 1-to-7-point scale representing self-perceived difficulty with total scores ranging from 32 to 224 (higher scores demonstrating greater UE function) and right and left scores assessed separately
9 secondary outcomes
Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)
Time frame: Weeks 0, 8, 12, 21, and 25
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time frame: Weeks 0, 8, 12, 21, and 25
Pinch and Grasp Force
Time frame: Weeks 0, 8, 12, 21, and 25
Global Rating of Change (GRC)
Time frame: Weeks 8, 12, 21, and 25
Satisfaction with Treatment Scale
Time frame: Weeks 8, 12, 21, and 25
Qualitative Questions
Time frame: Weeks 8 and 21
Canadian Occupational Performance Measure (COPM)
Time frame: Weeks 0, 8, 12, 21, and 25
International Spinal Cord Injury Quality of Life Basic Data Set (QoL-BDS) Version 2.0
Time frame: Weeks 0, 8, 12, 21, and 25
International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) Version 3.0
Time frame: Weeks 0, 8, 12, 21, and 25
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 31 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Intervention in people with Cervical Spinal Cord Injury, run by Craig Hospital 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 13 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 31 Mar 2026. 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.
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?
Contact Candy Tefertiller, PT, DPT, PhD, NCS (303-789-8000, ctefertiller@craighospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capabilities of Upper Extremity Questionnaire (CUE-Q) (time frame: Weeks 0, 8, 12, 21, and 25). 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 31 Mar 2026.