Cervical Spinal Cord InjuryNCT03464409
Supporting Patient Decisions About UE Surgery in Cervical SCI
A study testing Semi-structured interview, Spinal Cord Independence Measure (SCIM-SR) and SF-36 in people with Cervical Spinal Cord Injury, run by Washington University School of Medicine at 4 sites in United States.
Trial summary
The goal of this study is to collect and describe patient and caregiver reported outcomes regarding surgical and non-surgical treatment for improving hand and arm function in the setting of cervical spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Spinal Cord Injury
- What is being tested?
- Semi-structured interview, Spinal Cord Independence Measure (SCIM-SR) and SF-36
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Mar 2018to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (≥18 years and < 80 years) with cervical level SCI ASIA A, B or C (minimum 6 months and maximum 20 years post-injury).
- At least 18 years of age
- Able to answer questions about the primary participant's experiences with cervical spinal cord injury
Who cannot join
- Patient who chooses simultaneous tendon and nerve transfer procedure (this would preclude separation of the influence of one surgery compared to the other)
- Patient has ASIA D status (these patients may have progressive return of functionally useful motor function below the level of the SCI and would not routinely be offered acute surgical intervention and their experiences are less-relevant to the target patient population).
- CAREGIVER PARTICIPANTS
- The caregiver/spouse declines to participate in the study. Note: Caregiver participation is preferred, but not required, for SCI participant enrollment.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, 94304
Veterans Affairs St. Louis Health Care System
St Louis, Missouri, 63106
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
About this study
Official title: Supporting Patient Decisions About Upper Extremity Surgery in Cervical Spinal Cord Injury (Aim 2)
The goal of this study is to collect and describe patient and caregiver reported outcomes regarding surgical and non-surgical treatment for improving hand and arm function in the setting of cervical spinal cord injury. Eligible study participants will be recruited across the 4 sites and the investigators plan to recruit the following groups and numbers of participants:
- Nerve or tendon transfer recipients: people who have elected to undergo nerve (N=10) or tendon (N=10) transfer surgery to restore some hand and arm function as part of their standard clinical care and their caregiver (N=20)
- Non-surgical control group: people with cervical SCI (N=20) and their caregiver (N=20)
Read the detailed description
At present, there is limited information that provides the exact time course and probability of gain in specific function (such as hand function) that might help patients and clinicians make decisions regarding novel and time-sensitive surgical treatment options.
Understanding the pros and cons of any surgical intervention, especially in the setting of complex and often incomplete information, is challenging. Ultimately, this project will create a decision support intervention (DSI) that can be used to help clinicians and people living with cervical level SCI and their caregivers. It will be most useful to those with acute or sub-acute injury (< 1year after SCI) for both military personnel and the general public. Clinicians and patients will have evidence to help them make decisions about treatments to improve upper extremity function.
In such a manner, patients can make more well-informed choices that are consistent with their values, needs and goals.
- Conditions
- Cervical Spinal Cord Injury
- Being tested
- Semi-structured interview, Spinal Cord Independence Measure (SCIM-SR), SF-36
- Keywords
- Nerve Transfer Surgery, Tendon Transfer Surgery, Decision Support Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewOther
Semi-structured interviews to be conducted by a study team member.
Spinal Cord Independence Measure (SCIM-SR)Other
The Spinal Cord Independence Measure - Self Report (SCIM-SR) is a self-report instrument for assessing functional independence of persons with spinal cord injury.
SF-36Other
A health-related quality of life (QoL) self-reported survey.
| Study group | Role | What they receive |
|---|---|---|
| SCI Patient - Nerve Transfer Surgery | Active comparator | Patients aged 18 to 80 with a mid cervical level spinal cord injury seeking nerve transfer surgery to improve hand and arm function. Participants will be assessed at 3 time points: Baseline (pre-operatively), Early Followup (1 month post-operatively) and Late Followup (6-24 months later). Assessments will include the Spinal Cord Independence Measure (SCIM-SR), the 36-Item Short Form Health Survey (SF-36), and a semi-structured interview to be conducted by a study team member. Receives: Other: Semi-structured interview; Other: Spinal Cord Independence Measure (SCIM-SR); Other: SF-36 |
| SCI Patient - Tendon Transfer Surgery | Active comparator | Patients aged 18 to 80 with a mid cervical level spinal cord injury seeking tendon transfer surgery to improve hand and arm function. Participants will be assessed at 3 time points: Baseline (pre-operatively), Early Followup (1 month post-operatively) and Late Followup (6-24 months later). Assessments will include the Spinal Cord Independence Measure (SCIM-SR), the 36-Item Short Form Health Survey (SF-36), and a semi-structured interview to be conducted by a study team member. Receives: Other: Semi-structured interview; Other: Spinal Cord Independence Measure (SCIM-SR); Other: SF-36 |
| SCI Patient - No Surgery | Active comparator | Patients aged 18 to 80 with a mid cervical level spinal cord injury who did not chose to have surgery to improve hand and arm function. Participants will be assessed at 3 time points: Baseline, Early Followup (1 month later), and Late Followup (6-24 months later). Assessments will include the Spinal Cord Independence Measure (SCIM-SR), the 36-Item Short Form Health Survey (SF-36), and a semi-structured interview to be conducted by a study team member. Receives: Other: Semi-structured interview; Other: Spinal Cord Independence Measure (SCIM-SR); Other: SF-36 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative (interview) Analysis
All interviews will be transcribed verbatim and analyzed using standard qualitative text analysis. Members of the research team will read the transcripts for accuracy and to determine potential topics for coding. The investigators will develop a codebook using inductive and deductive codes. Deductive codes will be directly linked to our research questions. Adding inductive codes, where topics and codes are not pre-determined but are derived directly from the data, will allow the research team to develop a sense of how patients experience the surgical process, and allows for unexpected findings to emerge. Once the codebook is determined, two members of the research team will code the transcripts. Codes will be compared between raters. The investigators will use the codes to infer themes in the data.
Measured: 24 months
Secondary outcomes (1)
Quantitative (survey) Data Analysis
The data analysis will be conducted within each group. To account for correlations among repeated measures from the same patient, the longitudinal data will be analyzed using a mixed model to examine the change in survey outcomes.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start13 Mar 2018
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, VA St. Louis Health Care System, VA Palo Alto Health Care System, Stanford University
- Responsible party
- Sponsor
- Investigators
- Ida K Fox, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464409
- Sponsor's protocol ID
- 201706092
- Status last verified
- Nov 2021
- First submitted
- 7 Mar 2018
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Nerve Transfers to Restore Upper Extremity Function in Cervical Spinal Cord Injury: Update and Preliminary Outcomes. Plast Reconstr Surg. 2015 Oct;136(4):780-792. doi: 10.1097/PRS.0000000000001641.
PubMed 26397252Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Use of peripheral nerve transfers in tetraplegia: evaluation of feasibility and morbidity. Hand (N Y). 2015 Mar;10(1):60-7. doi: 10.1007/s11552-014-9677-z.
PubMed 25767422Curtin CM, Gater DR, Chung KC. Upper extremity reconstruction in the tetraplegic population, a national epidemiologic study. J Hand Surg Am. 2005 Jan;30(1):94-9. doi: 10.1016/j.jhsa.2004.10.007.
PubMed 15680562Bertelli JA, Ghizoni MF, Tacca CP. Transfer of the teres minor motor branch for triceps reinnervation in tetraplegia. J Neurosurg. 2011 May;114(5):1457-60. doi: 10.3171/2010.12.JNS101519. Epub 2011 Jan 21.
PubMed 21250798Bertelli JA, Ghizoni MF. Nerve transfers for elbow and finger extension reconstruction in midcervical spinal cord injuries. J Neurosurg. 2015 Jan;122(1):121-7. doi: 10.3171/2014.8.JNS14277.
PubMed 25343189Bertelli JA, Tacca CP, Ghizoni MF, Kechele PR, Santos MA. Transfer of supinator motor branches to the posterior interosseous nerve to reconstruct thumb and finger extension in tetraplegia: case report. J Hand Surg Am. 2010 Oct;35(10):1647-51. doi: 10.1016/j.jhsa.2010.07.012.
PubMed 20888500Friden J, Gohritz A. Brachialis-to-extensor carpi radialis longus selective nerve transfer to restore wrist extension in tetraplegia: case report. J Hand Surg Am. 2012 Aug;37(8):1606-8. doi: 10.1016/j.jhsa.2012.05.005. Epub 2012 Jun 30.
PubMed 22749482Curtin CM, Hayward RA, Kim HM, Gater DR, Chung KC. Physician perceptions of upper extremity reconstruction for the person with tetraplegia. J Hand Surg Am. 2005 Jan;30(1):87-93. doi: 10.1016/j.jhsa.2004.08.014.
PubMed 15680561Wagner JP, Curtin CM, Gater DR, Chung KC. Perceptions of people with tetraplegia regarding surgery to improve upper-extremity function. J Hand Surg Am. 2007 Apr;32(4):483-90. doi: 10.1016/j.jhsa.2007.01.015.
PubMed 17398358Fox PM, Suarez P, Hentz VR, Curtin CM. Access to surgical upper extremity care for people with tetraplegia: an international perspective. Spinal Cord. 2015 Apr;53(4):302-5. doi: 10.1038/sc.2015.3. Epub 2015 Feb 17.
PubMed 25687516Anderson KD, Friden J, Lieber RL. Acceptable benefits and risks associated with surgically improving arm function in individuals living with cervical spinal cord injury. Spinal Cord. 2009 Apr;47(4):334-8. doi: 10.1038/sc.2008.148. Epub 2008 Nov 25.
PubMed 19030014Cain SA, Gohritz A, Friden J, van Zyl N. Review of Upper Extremity Nerve Transfer in Cervical Spinal Cord Injury. J Brachial Plex Peripher Nerve Inj. 2015 Aug 6;10(1):e34-e42. doi: 10.1055/s-0035-1558427. eCollection 2015 Dec.
PubMed 27917237Joseph-Williams N, Newcombe R, Politi M, Durand MA, Sivell S, Stacey D, O'Connor A, Volk RJ, Edwards A, Bennett C, Pignone M, Thomson R, Elwyn G. Toward Minimum Standards for Certifying Patient Decision Aids: A Modified Delphi Consensus Process. Med Decis Making. 2014 Aug;34(6):699-710. doi: 10.1177/0272989X13501721. Epub 2013 Aug 20.
PubMed 23963501Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
PubMed 24470076
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Patient Decisions About Upper Extremity Surgery in Cervical Spinal Cord Injury (Aim 2)
- ClinicalTrials.gov ID
- NCT03464409
- Acronym / sponsor ID
- 201706092
- Conditions
- Cervical Spinal Cord Injury
- Keywords
- Nerve Transfer Surgery, Tendon Transfer Surgery, Decision Support Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- United States Department of Defense, VA St. Louis Health Care System, VA Palo Alto Health Care System, Stanford University
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 14 Mar 2018 (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 goal of this study is to collect and describe patient and caregiver reported outcomes regarding surgical and non-surgical treatment for improving hand and arm function in the setting of cervical spinal cord injury. Eligible study participants will be recruited across the 4 sites and the investigators plan to recruit the following groups and numbers of participants:
- Nerve or tendon transfer recipients: people who have elected to undergo nerve (N=10) or tendon (N=10) transfer surgery to restore some hand and arm function as part of their standard clinical care and their caregiver (N=20)
- Non-surgical control group: people with cervical SCI (N=20) and their caregiver (N=20)
Detailed description
At present, there is limited information that provides the exact time course and probability of gain in specific function (such as hand function) that might help patients and clinicians make decisions regarding novel and time-sensitive surgical treatment options.
Understanding the pros and cons of any surgical intervention, especially in the setting of complex and often incomplete information, is challenging. Ultimately, this project will create a decision support intervention (DSI) that can be used to help clinicians and people living with cervical level SCI and their caregivers. It will be most useful to those with acute or sub-acute injury (< 1year after SCI) for both military personnel and the general public. Clinicians and patients will have evidence to help them make decisions about treatments to improve upper extremity function.
In such a manner, patients can make more well-informed choices that are consistent with their values, needs and goals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SCI Patient - Nerve Transfer Surgery | Active comparator | Other: Semi-structured interview, Other: Spinal Cord Independence Measure (SCIM-SR), Other: SF-36Patients aged 18 to 80 with a mid cervical level spinal cord injury seeking nerve transfer surgery to improve hand and arm function. Participants will be assessed at 3 time points: Baseline (pre-operatively), Early Followup (1 month post-operatively) and Late Followup (6-24 months later). Assessments will include the Spinal Cord Independence Measure (SCIM-SR), the 36-Item Short Form Health Survey (SF-36), and a semi-structured interview to be conducted by a study team member. |
| SCI Patient - Tendon Transfer Surgery | Active comparator | Other: Semi-structured interview, Other: Spinal Cord Independence Measure (SCIM-SR), Other: SF-36Patients aged 18 to 80 with a mid cervical level spinal cord injury seeking tendon transfer surgery to improve hand and arm function. Participants will be assessed at 3 time points: Baseline (pre-operatively), Early Followup (1 month post-operatively) and Late Followup (6-24 months later). Assessments will include the Spinal Cord Independence Measure (SCIM-SR), the 36-Item Short Form Health Survey (SF-36), and a semi-structured interview to be conducted by a study team member. |
| SCI Patient - No Surgery | Active comparator | Other: Semi-structured interview, Other: Spinal Cord Independence Measure (SCIM-SR), Other: SF-36Patients aged 18 to 80 with a mid cervical level spinal cord injury who did not chose to have surgery to improve hand and arm function. Participants will be assessed at 3 time points: Baseline, Early Followup (1 month later), and Late Followup (6-24 months later). Assessments will include the Spinal Cord Independence Measure (SCIM-SR), the 36-Item Short Form Health Survey (SF-36), and a semi-structured interview to be conducted by a study team member. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult subjects (≥18 years and < 80 years) with cervical level SCI ASIA A, B or C (minimum 6 months and maximum 20 years post-injury).
- At least 18 years of age
- Able to answer questions about the primary participant's experiences with cervical spinal cord injury
Key exclusion criteria (4 listed)
- Patient who chooses simultaneous tendon and nerve transfer procedure (this would preclude separation of the influence of one surgery compared to the other)
- Patient has ASIA D status (these patients may have progressive return of functionally useful motor function below the level of the SCI and would not routinely be offered acute surgical intervention and their experiences are less-relevant to the target patient population).
- CAREGIVER PARTICIPANTS
- The caregiver/spouse declines to participate in the study. Note: Caregiver participation is preferred, but not required, for SCI participant enrollment.
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 |
|---|---|---|
| Semi-structured interviewSemi-structured interviews to be conducted by a study team member. | Other | SCI Patient - Nerve Transfer Surgery, SCI Patient - No Surgery, SCI Patient - Tendon Transfer Surgery |
| Spinal Cord Independence Measure (SCIM-SR)The Spinal Cord Independence Measure - Self Report (SCIM-SR) is a self-report instrument for assessing functional independence of persons with spinal cord injury. | Other | SCI Patient - Nerve Transfer Surgery, SCI Patient - No Surgery, SCI Patient - Tendon Transfer Surgery |
| SF-36A health-related quality of life (QoL) self-reported survey. | Other | SCI Patient - Nerve Transfer Surgery, SCI Patient - No Surgery, SCI Patient - Tendon Transfer Surgery |
Primary outcome
Qualitative (interview) Analysis
Time frame: 24 months
All interviews will be transcribed verbatim and analyzed using standard qualitative text analysis. Members of the research team will read the transcripts for accuracy and to determine potential topics for coding. The investigators will develop a codebook using inductive and deductive codes. Deductive codes will be directly linked to our research questions. Adding inductive codes, where topics and codes are not pre-determined but are derived directly from the data, will allow the research team to develop a sense of how patients experience the surgical process, and allows for unexpected findings to emerge. Once the codebook is determined, two members of the research team will code the transcripts. Codes will be compared between raters. The investigators will use the codes to infer themes in the data.
1 secondary outcome
Quantitative (survey) Data Analysis
Time frame: 24 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 3 Nov 2021.
- Background: PubMed 26397252Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Nerve Transfers to Restore Upper Extremity Function in Cervical Spinal Cord Injury: Update and Preliminary Outcomes. Plast Reconstr Surg. 2015 Oct;136(4):780-792. doi: 10.1097/PRS.0000000000001641.
- Background: PubMed 25767422Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Use of peripheral nerve transfers in tetraplegia: evaluation of feasibility and morbidity. Hand (N Y). 2015 Mar;10(1):60-7. doi: 10.1007/s11552-014-9677-z.
- Background: PubMed 15680562Curtin CM, Gater DR, Chung KC. Upper extremity reconstruction in the tetraplegic population, a national epidemiologic study. J Hand Surg Am. 2005 Jan;30(1):94-9. doi: 10.1016/j.jhsa.2004.10.007.
- Background: PubMed 21250798Bertelli JA, Ghizoni MF, Tacca CP. Transfer of the teres minor motor branch for triceps reinnervation in tetraplegia. J Neurosurg. 2011 May;114(5):1457-60. doi: 10.3171/2010.12.JNS101519. Epub 2011 Jan 21.
- Background: PubMed 25343189Bertelli JA, Ghizoni MF. Nerve transfers for elbow and finger extension reconstruction in midcervical spinal cord injuries. J Neurosurg. 2015 Jan;122(1):121-7. doi: 10.3171/2014.8.JNS14277.
- Background: PubMed 20888500Bertelli JA, Tacca CP, Ghizoni MF, Kechele PR, Santos MA. Transfer of supinator motor branches to the posterior interosseous nerve to reconstruct thumb and finger extension in tetraplegia: case report. J Hand Surg Am. 2010 Oct;35(10):1647-51. doi: 10.1016/j.jhsa.2010.07.012.
- Background: PubMed 22749482Friden J, Gohritz A. Brachialis-to-extensor carpi radialis longus selective nerve transfer to restore wrist extension in tetraplegia: case report. J Hand Surg Am. 2012 Aug;37(8):1606-8. doi: 10.1016/j.jhsa.2012.05.005. Epub 2012 Jun 30.
- Background: PubMed 15680561Curtin CM, Hayward RA, Kim HM, Gater DR, Chung KC. Physician perceptions of upper extremity reconstruction for the person with tetraplegia. J Hand Surg Am. 2005 Jan;30(1):87-93. doi: 10.1016/j.jhsa.2004.08.014.
- Background: PubMed 17398358Wagner JP, Curtin CM, Gater DR, Chung KC. Perceptions of people with tetraplegia regarding surgery to improve upper-extremity function. J Hand Surg Am. 2007 Apr;32(4):483-90. doi: 10.1016/j.jhsa.2007.01.015.
- Background: PubMed 25687516Fox PM, Suarez P, Hentz VR, Curtin CM. Access to surgical upper extremity care for people with tetraplegia: an international perspective. Spinal Cord. 2015 Apr;53(4):302-5. doi: 10.1038/sc.2015.3. Epub 2015 Feb 17.
- Background: PubMed 19030014Anderson KD, Friden J, Lieber RL. Acceptable benefits and risks associated with surgically improving arm function in individuals living with cervical spinal cord injury. Spinal Cord. 2009 Apr;47(4):334-8. doi: 10.1038/sc.2008.148. Epub 2008 Nov 25.
- Background: PubMed 27917237Cain SA, Gohritz A, Friden J, van Zyl N. Review of Upper Extremity Nerve Transfer in Cervical Spinal Cord Injury. J Brachial Plex Peripher Nerve Inj. 2015 Aug 6;10(1):e34-e42. doi: 10.1055/s-0035-1558427. eCollection 2015 Dec.
- Center for Nerve Injury \& Paralysis, Washington University in St. Louis School of MedicineLink provided by the sponsor.
- 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.
Ida K Fox, MD principal investigator
Washington University School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-structured interview, Spinal Cord Independence Measure (SCIM-SR) and SF-36 in people with Cervical Spinal Cord Injury, run by Washington University School of Medicine at 4 sites 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 3 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: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Qualitative (interview) Analysis (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03464409, which also lists 14 linked publications.
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 3 Nov 2021.