Rehabilitation and Cortical Remodeling After Surgical Intervention for Spinal Cord Injury
Key facts
- Who runs it
- Burke Medical Research Institute
- Where
- White Plains, United StatesSee the site
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 2
- People taking part
- 6 people enrolled
- Started
- 26 Jul 2019
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Upper limb robotic training
- Nerve transfer surgery
- Record updated
- 23 August 2024
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Contraindicated for nerve transfer surgery
- 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
Where in United States
- Burke Neurological InstituteWhite Plains, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Nerve transfer + robotic trainingTreatment being tested
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.
Treatment: Upper limb robotic training and Nerve transfer surgery
- Nerve transfer + delayed robotic trainingExisting treatment, for comparison
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.
Treatment: Upper limb robotic training and Nerve transfer surgery
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 23 August 2024