Nerve Transfers for Restoration of Hand Function in Cervical Spinal Cord Injury: Effects and Influencing Factors

NCT06596629 | Completed

• 1 other identifier: 2024-17418
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about influencing factors on the clinical outcomes of nerve transfers used to restore hand function in patients with cervical spinal cord injury (CSCI). Specifically, the study focuses on the reinnervation of the posterior interosseus nerve (PIN) and the anterior interosseus nerve (AIN). The main questions it aims to answer are:

1. 1.What is the duration after nerve transfer surgery until effect is achieved?
2. 2.What is the influence of the participants age during surgery on the effect of a nerve transfer?
3. 3.What is the impact of time interval from the date of spinal cord injury to the date of nerve transfer surgery?

Conditions

Nerve Transfer

Keywords

spinal cord injury; tetraplegia; posterior interosseus nerve; anterior interosseus nerve; hand function

Outcome Measures

Primary Outcomes (1)

• Duration until result of nerve transfers

  Defined as the time until 'first result' or 'desired result' is achieved following nerve transfer surgery. First result: defined as the first visible muscle contraction in the reinnervated muscles. For the posterior interosseus nerve (PIN), this includes any contraction of thumb and/or finger extension. For the anterior interosseus nerve (AIN), this refers to any visible flexion of thumb, index finger and middle fingers . Desired result: for reanimation of the posterior interosseus nerve (PIN), this is defined as the patient's ability to extent the thumb and fingers sufficiently to achieve a desirable hand opening. Successful reinnervation of the anterior interosseus nerve (AIN) will be documented when patients are able to flex the thumb and fingers to form a fist. Dates of first result, desired result and date of surgery will be extracted from patient's records. Duration after surgery until 'first result' and 'desired result' will be expressed in months.

  up to 4 weeks

Secondary Outcomes (2)

• Age during surgery

  Up to 4 weeks

• Time between spinal cord injury and nerve transfer surgery

  Up to 4 weeks

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a cervical spinal cord injury, ≥ 12 years and older, who underwent single or multiple nerve transfers in one or both upper limbs to reanimate the posterior interosseus nerve (PIN) and/or anterior interosseus nerve (AIN).

You may qualify if:

• patients with cervical spinal cord injury
• single or multiple nerve transfers in one or both upper limbs to reanimate the posterior interosseus nerve (PIN) or anterior interosseus nerve (AIN).
• Surgery performed in Medical Spectrum Twente (MST) in Enschede.
• Postoperative treatment in Roessingh, Centre for Rehabilitation (RCR) in Enschede.
• Surgeries performed between February 2019 and February 2024.

You may not qualify if:

• patients with pre-existing neurological comorbidities

Sponsors & Collaborators

• Roessingh Research and Development: lead

Study Sites (1)

Roessingh, Centre for Rehabilitation

Enschede, Overijssel, 7522AH, Netherlands

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nora W Jacobs, MD

  Roessingh,Centre for Rehabilitation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

NL (1)