| Condition or disease | Intervention/treatment |
|---|---|
| Tetraplegia Spinal Cord Injuries Quadriplegia Flaccid | Procedure: Surgery/Occupational Therapy |
Study Design and Feasibility: A prospective multi-institutional non-randomized single arm design will be utilized. Seventy subjects with cervical ASIA A-B (International Standards for Neurological Classification of Spinal Cord Injury) SCI and hand function impairment that fit the International Classification for Surgery of the Hand 0-4 will be identified. Only patients with stable ASIA scores and no evidence of functional improvement in motor or sensory examination for at least 3 months will be recruited. All patients will undergo Electromyography (EMG) and nerve conduction studies (NCS) to verify intact innervation (normal compound muscle action potentials (CMAPs)) to the paralyzed target muscles below the level of injury. Functional electrical stimulation (FES) will be used to verify loss of lower motor neuron function in key muscle groups in the zone of injury and help differentiate those muscle with intact connections to preserve anterior horn cells. Only those patients with clinically normal, Medical Research Council (MRC) muscle grade 5/5 donor (axonal donor) function will be enrolled.
Outcome Measures Primary Outcome Measures: Pre- and Post-operative upper motor strength. (Manual motor testing & Hand Held Dynamometry) Secondary Outcome Measures: Disabilities of the Arm, Shoulder, and Hand (DASH), Michigan Hand Questionnaire (MHQ), Spinal Cord Injury Quality of Life (SCIQOL), GRASSP test (pre-operative, post-operatively - 6 months, 12 months, and 24 months, 36 months and 48 months), rates of intraoperative and post-operative complications, and rates of reoperation.
Rehabilitation and hand therapy are critical components of motor re-education following nerve transfers. Cortical plasticity and motor remapping occurs following nerve transfers allowing independent functional control of the recipient muscles. All patients will begin rehabilitation and hand therapy beginning 2 weeks after surgery. They undergo one hour of hand therapy and occupational therapy for motor re-education once to twice a week for 48 months following surgery. Rehabilitation will be phased to early and late - added exercises focusing on co-contraction, repetition, and range of motion will be included as home therapy.
| Study Type : | Observational |
| Estimated Enrollment : | 70 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Nerve Transfers to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients |
| Actual Study Start Date : | April 13, 2020 |
| Estimated Primary Completion Date : | March 2026 |
| Estimated Study Completion Date : | December 2026 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Surgery
Surgery/ Occupational Therapy
|
Procedure: Surgery/Occupational Therapy
Surgery based on function and injury/ Occupational therapy for 48 months post-surgery
|
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria
Exclusion Criteria
| Contact: Linda A Koester, BS | 314-362-7368 | koesterl@wustl.edu | |
| Contact: Joan Atencio | 314-362-3114 | atencio@wustl.edu |
| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Anthony Bet, BS 650-683-5823 abet0915@stanford.edu | |
| Contact: Thomas Wilson, MD wilsontj@stanford.edu | |
| Principal Investigator: Thomas J Wilson, MD | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Karen Sagher 734-975-2589 kfrisch@med.umich.edu | |
| Contact: Kate Chang 734-975-2589 katewc@med.umich.edu | |
| Principal Investigator: Linda Yang, MD | |
| United States, Missouri | |
| Washington University | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Linda Koester, BS 314-362-7368 koesterl@wustl.edu | |
| Contact: Joan Atencio 314-362-3114 atencio@wustl.edu | |
| Sub-Investigator: Neringa Juknis, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Leah Coghlan, BSN 215-615-5436 ncrdneuroicu@uphs.upenn.edu | |
| Principal Investigator: Eric Zager, MD | |
| United States, Texas | |
| The University of Texas Houston Health Science Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Rebecca Martinez, BSN 713-500-6141 rebecca.martinez@uth.tmc.edu | |
| Principal Investigator: Wesley Jones, MD | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Kirby Taylor 801-587-2924 kirby.taylor@utah.edu | |
| Contact: Mark Mahan, MD mark.mahan@hsc.utah.edu | |
| Principal Investigator: Mark Mahan, MD | |
| Canada, Alberta | |
| Alberta Health Services - Foothills Medical Center | Recruiting |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Contact: Ish Bains 403-944-4334 Ish.Bains@albertahealthservices.ca | |
| Principal Investigator: Rajiv Midha, MD | |
| Principal Investigator: | Wilson Z Ray, MD | Washington University School of Medicine |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 11, 2019 | ||||||||
| First Posted Date | July 17, 2019 | ||||||||
| Last Update Posted Date | October 12, 2020 | ||||||||
| Actual Study Start Date | April 13, 2020 | ||||||||
| Estimated Primary Completion Date | March 2026 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures |
|
||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Nerve Transfer After Spinal Cord Injury- Multi-center | ||||||||
| Official Title | Nerve Transfers to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients | ||||||||
| Brief Summary | Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of like and long-term functional independence will provide a significant public health impact. Specific aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and quality of life and functional independence. | ||||||||
| Detailed Description |
Study Design and Feasibility: A prospective multi-institutional non-randomized single arm design will be utilized. Seventy subjects with cervical ASIA A-B (International Standards for Neurological Classification of Spinal Cord Injury) SCI and hand function impairment that fit the International Classification for Surgery of the Hand 0-4 will be identified. Only patients with stable ASIA scores and no evidence of functional improvement in motor or sensory examination for at least 3 months will be recruited. All patients will undergo Electromyography (EMG) and nerve conduction studies (NCS) to verify intact innervation (normal compound muscle action potentials (CMAPs)) to the paralyzed target muscles below the level of injury. Functional electrical stimulation (FES) will be used to verify loss of lower motor neuron function in key muscle groups in the zone of injury and help differentiate those muscle with intact connections to preserve anterior horn cells. Only those patients with clinically normal, Medical Research Council (MRC) muscle grade 5/5 donor (axonal donor) function will be enrolled. Outcome Measures Primary Outcome Measures: Pre- and Post-operative upper motor strength. (Manual motor testing & Hand Held Dynamometry) Secondary Outcome Measures: Disabilities of the Arm, Shoulder, and Hand (DASH), Michigan Hand Questionnaire (MHQ), Spinal Cord Injury Quality of Life (SCIQOL), GRASSP test (pre-operative, post-operatively - 6 months, 12 months, and 24 months, 36 months and 48 months), rates of intraoperative and post-operative complications, and rates of reoperation. Rehabilitation and hand therapy are critical components of motor re-education following nerve transfers. Cortical plasticity and motor remapping occurs following nerve transfers allowing independent functional control of the recipient muscles. All patients will begin rehabilitation and hand therapy beginning 2 weeks after surgery. They undergo one hour of hand therapy and occupational therapy for motor re-education once to twice a week for 48 months following surgery. Rehabilitation will be phased to early and late - added exercises focusing on co-contraction, repetition, and range of motion will be included as home therapy. |
||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Participants with a traumatic cervical spine injury with little to no use of his/her arms/hands. | ||||||||
| Condition |
|
||||||||
| Intervention | Procedure: Surgery/Occupational Therapy
Surgery based on function and injury/ Occupational therapy for 48 months post-surgery
|
||||||||
| Study Groups/Cohorts | Surgery
Surgery/ Occupational Therapy
Intervention: Procedure: Surgery/Occupational Therapy
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
70 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 2026 | ||||||||
| Estimated Primary Completion Date | March 2026 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria
Exclusion Criteria
|
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| Sex/Gender |
|
||||||||
| Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
||||||||
| Listed Location Countries | Canada, United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04023591 | ||||||||
| Other Study ID Numbers | SC180063 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Washington University School of Medicine | ||||||||
| Study Sponsor | Washington University School of Medicine | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Washington University School of Medicine | ||||||||
| Verification Date | October 2020 | ||||||||