RECRUITING

Grasp-Release Assessment of a Networked Neuroprosthesis Device

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Conditions

Spinal Cord Injury at C5-C7 LevelSpinal Cord InjuriesSpinal Cord Injury Cervical

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overall objective of this trial is to characterize the safety and effectiveness of the Networked Neuroprosthesis Device - Upper Extremity (NP-UE) in individuals living with cervical SCI.

Official Title

Grasp-Release Assessment of a Networked Neuroprosthesis Device

Quick Facts

Study Start:2022-01-23
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05863754

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, age \> 16 years.
  2. * Cervical level spinal cord injury, as defined by:
  3. 1. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor level of C1 through C7 and
  4. 2. American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B, or C;
  5. * Six months or more post-injury (neurostability);
  6. * Neurologically stable following any nerve transfers affecting the upper extremity (typically, one year post surgery);
  7. * Musculoskeletally and neurologically stable following any tendon transfers affecting the upper extremity (typically, 6-months).
  8. * Peripheral nerve innervation to upper extremity muscles, including a grade 3/5 or higher Stimulated Manual Muscle Test (SMMT) strength in at least two of the following muscles in one arm:
  9. 1. Adductor Pollicus, Abductor Pollicus Brevis (AbPB), Flexor Pollicus Longus (FPL), Extensor Pollicus Longus (EPL)/Extensor Pollicus Brevis (EPB), Extensor Digitorum Communis (EDC), Flexor Digitorum Superficialis (FDS), Flexor Digitorum Profundus (FDP), Pronator Quadratus (PQ), Extensor Carpi Ulnaris (ECU), Extensor Carpi Radialis Brevis (ECRB), Extensor Carpi Radialis Longus (ECRL), Flexor Carpi Ulnaris (FCU), Flexor Carpi Radialis (FCR), First Dorsal Interosseous(1DI), triceps,
  10. 2. At least two of the grade 3/5 or higher excitable muscles must also have grade 2/5 or lower voluntary strength;
  11. * Good proximal upper extremity strength as defined by biceps/brachialis/brachioradialis strength of 2/5 or higher on Manual Muscle Test on the side intended for implantation;
  12. * Medically stable;
  13. * Able to understand and provide informed consent.
  1. * Other neurological conditions (MS(multiple Sclerosis), diabetes with peripheral nerve involvement); Associated peripheral nerve / brachial plexus injury
  2. * Progressive SCI;
  3. * Co-existing cervical spine pathology (syrinx, unstable segment)
  4. * Active implantable medical device (AIMD) such as a pacemaker or defibrillator;
  5. * Active untreated infection such as pressure injury, urinary tract infection, pneumonia;
  6. * History of coagulopathy, HIV, cardiopulmonary disease, bradycardia, poorly controlled autonomic dysreflexia, or chronic obstructive pulmonary disease that would preclude safe participation in the trial as determined by the investigator;
  7. * Unhealed fractures that prevent functional use of arm;
  8. * Extensive upper extremity denervation (fewer than two excitable hand muscles);
  9. * Involvement in other ongoing clinical studies that exclude concurrent involvement in this study;
  10. * Disorder or condition that requires MRI monitoring;
  11. * Mechanical ventilator dependency;
  12. * Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant);
  13. * Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
  14. * Other significant medical findings that, in the opinion of the investigator, preclude safe participation in the trial.

Contacts and Locations

Study Contact

KIm Walsh, OTR/L
CONTACT
216-957-3512
kwalsh3@metrohealth.org
Anne Bryden, Ph.D, OTR/L
CONTACT
216-957-3594
anne.bryden@case.edu

Principal Investigator

Anne Bryden, PhD, OTR/L
PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center

Study Locations (Sites)

MetroHealth Medical Center
Cleveland, Ohio, 44109
United States

Collaborators and Investigators

Sponsor: MetroHealth Medical Center

  • Anne Bryden, PhD, OTR/L, PRINCIPAL_INVESTIGATOR, MetroHealth Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-23
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2022-01-23
Study Completion Date2027-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Cord Injury at C5-C7 Level
  • Spinal Cord Injuries
  • Spinal Cord Injury Cervical