Rehabilitation and Cortical Remodeling After Surgical Intervention for Spinal Cord Injury

NCT04041063 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-08-23

No results posted yet for this study

Summary

The aim of this study is to determine the effects of rehabilitation on dexterous hand movements and cortical motor map changes in tetraplegic patients following nerve transfer surgery. The working hypothesis is that robot-assisted, intensive rehabilitation will support the return of hand and arm function and strengthen the cortical representations of targeted muscles. The investigators will assess this through TMS mapping and clinical measures of hand and arm function.

Conditions

  • Spinal Cord Injuries
  • Tetraplegia
  • Cervical Spinal Cord Injury

Interventions

DEVICE

Upper limb robotic training

Subjects will remain seated in their own wheelchair in front of the InMotion Hand™ Robot (Interactive Motion Technologies, Massachusetts, MA, Figure 6) facing a video screen. The arm of the participants will be abducted, forearm supported, and hand grasping a cone shaped handle. Velcro straps will lightly hold the forearm and fingers secure. The InMotion Hand™ robot attaches to the InMotion Arm™ robots to provide 'assisted-as-needed'™ gross grasp and release motion and support for functional reach. In each session, patients perform a total of 1024 movement repetitions (Cortes et al., 2013). Patients will receive a total of 18 sessions (3x/week, 6 weeks) comprising one hour of interactive hand robotic training. The interactive robotic features involve visuomotor task, moving the robotic manipulandum according to targets on a computer screen mounted at eye level.

PROCEDURE

Nerve transfer surgery

C5 injury; Teres minor branch of axillary nerve transferred to long head of triceps branch of radial nerve (RN); Brachialis branch of musculocutaneous nerve to anterior interosseous nerve (AIN); Supinator branch of RN to posterior interosseous nerve (PIN). C6 injury; Teres minor branch of axillary nerve to long head of triceps branch of RN; Extensor carpi radialis brevis (ECRB) branch of RN to AIN; Supinator branch of RN to PIN. C7 injury with preserved triceps, loss of grasp/release; Pronator teres branch of median nerve to AIN; Terminal branch of ECRB branch of RN to flexor pollicis longus branch of AIN; Supinator branch of RN transferred to PIN. C7 injury with preserved triceps/finger extension, loss of grasp; Pronator teres branch of median nerve to AIN; Terminal branch of ECRB branch of RN to flexor pollicis longus branch of AIN.

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER
  • Burke Medical Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-26
Primary Completion
2025-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04041063 on ClinicalTrials.gov