RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation

Launched by NATIONAL NEUROSCIENCE INSTITUTE · Nov 30, 2022

Keywords

ClinConnect Summary

The RESTORES Trial is a study designed to explore a new way to help people with chronic spinal cord injuries (SCI) regain some movement and function. It involves using a device called an epidural spinal stimulator, which sends electrical signals to the spinal cord, along with advanced robotic rehabilitation. This trial will include three adult participants, aged 21 and older, who have had complete spinal cord injuries for more than a year and have certain reflexes still functioning below their injury site.

If you or a loved one is interested in participating, the study requires that you meet specific criteria, such as having a spinal injury between the T2 and L1 levels and being able to follow a rehabilitation program. Participants can expect to undergo rehabilitation sessions before and after the device is implanted to assess any improvements in their condition. The trial is currently recruiting participants and aims to provide valuable insights into the potential benefits of spinal stimulation in helping individuals with chronic SCI.

Gender

ALL

Eligibility criteria

• • ⦁ Inclusion Criteria
• For inclusion in the study, the potential patient has to fulfil all of the following criteria:
• • 1. 21 years old and older
• • 2. Chronic (greater than one year) motor complete (AIS classification A or B) SCI
• • 3. Spinal injury between the levels of Thoracic 2 (T2) to Lumbar 1 (L1)
• • 4. Segmental reflexes that remain functional below the level of lesion
• • 5. Able to perform the perioperative rehabilitation program as judged by the research team
• • Exclusion Criteria
• Potential patients will be excluded from the trial if they fulfil any of the following criteria:
• • 1. Significant medical co-morbidities that would significantly increase the risk of the operation
• • 2. Severe dysautonomia with systolic blood pressure fluctuation less than 50 or more than 200mmHg on tilt table testing
• • 3. Painful musculoskeletal dysfunction, contractures, unhealed fractures, pressure sores, severe spasticity, and osteoporosis
• • 4. Significant psychological issues or ongoing drug abuse
• • 5. Pregnancy and lactating patients
• • 6. Progressive spinal cord disease