Rehabilitation and Cortical Remodeling After Surgical Intervention for Spinal Cord Injury

NCT04041063 | Active Not Recruiting Phase 2 FDA Device

• 1 other identifier: SCI_nerve_transfer_robotics
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

robotics, hand function

Outcome Measures

Primary Outcomes (1)

• Change in Box and Blocks test score

  The Box and Blocks test measures how many blocks a person can grasp and transfer in one minute. A higher score is associated with better hand function.

  1 year post surgery, immediately post training, minus baseline before surgery

Secondary Outcomes (4)

• Upper extremity motor score (UEMS)

  1 year post surgery, immediately post training, minus baseline before surgery

• Spinal Cord Independence Measure (SCIM III)

  1 year post surgery, immediately post training, minus baseline before surgery

• Modified Ashworth Scale

  1 year post surgery, immediately post training, minus baseline before surgery

• Single pulse transcranial magnetic stimulation

  1 year post surgery, immediately post training, minus baseline before surgery

Study Arms (2)

Nerve transfer + robotic training

EXPERIMENTAL

Participants will receive nerve transfer surgery at Massachusetts General Hospital in Boston, MA. One year after the surgery, participants will receive six weeks of upper limb robotic training at the Burke Neurological Institute in White Plains, NY.

Device: Upper limb robotic training; Procedure: Nerve transfer surgery

Nerve transfer + delayed robotic training

ACTIVE COMPARATOR

Participants will receive nerve transfer surgery at Massachusetts General Hospital in Boston, MA. One year + six weeks after the surgery, participants will receive six weeks of upper limb robotic training at the Burke Neurological Institute in White Plains, NY.

Device: Upper limb robotic training; Procedure: Nerve transfer surgery

Interventions

Upper limb robotic training DEVICE

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.

Nerve transfer + delayed robotic training; Nerve transfer + robotic training

Nerve transfer surgery PROCEDURE

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.

Nerve transfer + delayed robotic training; Nerve transfer + robotic training

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Tetraplegia (cervical lesion) with some degree of motor dysfunction in the hand
• Motor incomplete or complete lesion (measured by the ASIA Impairment Scale, A, B, C, D).
• Chronic lesion (at least 6months after the injury)
• Demonstrate stability of motor examination for at least six months.
• Retain intact innervation within paralyzed target muscles (axon recipient) as determined by electrodiagnostics.
• Have muscles innervated by the nerves to be used for the transfers (axon donors) of MRC grade 4/5 or greater and sufficient innervation as determined by electrodiagnostics.
• Have access to an at home caregiver who can assist with customary postsurgical physical therapy.
• Ability to give informed consent and understand the tasks involved.

You may not qualify if:

• Presence of potential risk factor for brain stimulation: history of seizures, presence of surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull.
• History of head trauma and/or cognitive deficit
• Medically unstable
• Contraindicated for nerve transfer surgery.

Sponsors & Collaborators

• Burke Medical Research Institute: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Burke Neurological Institute

White Plains, New York, 10605, United States

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will not have knowledge of the time point at which they are assessing the participant.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive nerve transfer surgery. Half of the participants will receive 6 weeks of robotic training starting one year after the surgery. The other half of the participants will receive 6 weeks of robotic training starting one year plus 6 weeks after the nerve transfer surgery.

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 1, 2019
• Study Start: July 26, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)