Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT05638191|
Recruitment Status : Recruiting
First Posted : December 6, 2022
Last Update Posted : December 6, 2022
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|Condition or disease|
|Spinal Cord Injury Spinal Cord Injury at C5-C7 Level SCI - Spinal Cord Injury Upper Extremity Paralysis Upper Extremity Dysfunction Tetraplegia Upper Extremity Paresis Cervical Spinal Cord Injury|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||60 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Nerve Transfer Surgery to Restore Upper-limb Function After Ceervical Spinal Cord Injury|
|Actual Study Start Date :||June 3, 2021|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2026|
Experiemental: Surgical Arm
Individuals in this group will receive nerve transfer surgery 6 - 9 months post cervical spine injury and be observed for two years post-operatively.
Individuals in this group will not have undergone nerve transfer surgery. They will be observed for two years post injury while receiving standard of care including medical and rehabilitation. We want to reinforce that individuals are not being randomized to surgery versus non-surgery. Rather individuals this group will either have made the decision not to undergo surgery, independent their participation in this study.
- Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) [ Time Frame: Baseline then every 3 months for 2 years ]A validated upper limb functional measures and previously is used in SCI (Kalsi-Ryan et al. 2012) incorporates three domains vital to upper limb function: sensation, strength, and prehension.
- Modified Ashworth scores (MAS) [ Time Frame: Baseline then every 3 months for 2 years ]Modified Ashworth Scale (MAS) have been utilized in spinal cord injury patient population to assess spasticity by examining muscle tones.
- Range of Motion [ Time Frame: Baseline then every 3 months for 2 years ]A Goniometer is used to measure range of motion of the joint angles (degrees) from the axis of the joint. The measurement of joint movements is compared to its full potential.
- Ultrasound [ Time Frame: Baseline then every 3 months for 2 years ]Ultrasound imaging to assess the structural health of recipient muscles and to quantify muscle fibrosis and atrophy.
- Spinal Cord Independence Measure (SCIM) [ Time Frame: Baseline then every 3 months for 2 years ]The SCIM has been developed to address three specific areas of function in patients with spinal cord injuries such as activities of daily living, respiration and sphincter management, and a patient's mobility abilities.
- Douleur Neuropathique 4 (DN-4) [ Time Frame: Baseline then every 3 months for 2 years ]A questionnaire consisting of 10 items and can be useful in assessment of neuropathic pain. The items related to pain quality are based on an interview and examination of the patient.
- Beck's Depression Inventory (BDI) [ Time Frame: Baseline then every 3 months for 2 years ]The questionnaire is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Motor complete (AIS A or B) between neurological level of injury C5 and C8
- Able to provide informed written consent
- Able to attend and comply with the testing protocols
- Able to understand and speak English or have access to an appropriate interpreter as judged by the investigator.
- An uncontrolled medical condition (e.g. uncontrolled cardiovascular disease, diabetes, kidney or liver disease)
- Have ever received botulinum toxin injections (Botox) for tone management in the upper limb
- An unmanaged secondary complication of SCI including but not limited to uncontrolled neuropathic pain or spasticity, syringomyelia, fracture, urinary tract infection or significant pressure ulcer, preventing participation in testing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05638191
|Contact: Michael Berger, MD, PhDfirstname.lastname@example.org|
|Canada, British Columbia|
|GF Strong Rehabilitation Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 2G9|
|Contact: Harvey Wu, MD email@example.com|
|Principal Investigator: Michael Berger, MD, PhD|
|Sub-Investigator: Russell O'Connor, MD|
|Sub-Investigator: Erin Brown, MD|
|Sub-Investigator: Chris Doherty, MD|
|Sub-Investigator: Amy Hanlan, MD|
|Canada, Nova Scotia|
|QEII Health Sciences Centre||Not yet recruiting|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Contact: Emily Krauss|
|Principal Investigator: Emily Krauss, MD, MSc|
|Kingston Health Sciences Centre||Not yet recruiting|
|Kingston, Ontario, Canada, K7L 5G2|
|Contact: Michael Hendry, MD, MSc|
|Principal Investigator: Michael Hendry, MD, MSc|
|Sunnybrook Health Sciences Centre||Not yet recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Jana Dengler, MD, MASc|
|Principal Investigator: Jana Dengler, MD, MASc|
|Principal Investigator:||Michael Berger, MD, PHD||University of British Columbia|
|Responsible Party:||Michael Berger, Clinical Assistant Professor, University of British Columbia|
|Other Study ID Numbers:||
|First Posted:||December 6, 2022 Key Record Dates|
|Last Update Posted:||December 6, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan Description:||The IPD sharing plan is under discussion.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
spinal cord injury
upper extremity nerve transfer
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System