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RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation (RS-01)

Primary Purpose

Chronic Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
RESToration Of Rehabilitative function with Epidural spinal Stimulation
Sponsored by
National Neuroscience Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Spinal Cord Injury focused on measuring Spinal cord injury, Epidural spinal stimulation, Implantation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Neuroscience InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with motor complete chronic spinal cord injury

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events assessed by CTCAE v5.0
The adverse events in patient's with proposed surgical implantation and robotic neuro-rehabilitation during the course of study will be assessed. Particularly, during the first 6 months of the study and post implantation.

Secondary Outcome Measures

Assessing the improvement in motor outcomes post surgical implantation
Volitional control including independent locomotion with epidural spinal stimulation and robotic neuro-rehabilitation will be assessed to check for improvement in motor functions. This assessment will be done during rehabilitation session where the post-surgical movement results will be compared against the pre-surgical results for better understanding and study.
Assessing autonomic function post surgical implantation
The improvement in hemodynamic, bowel and bladder control with epidural spinal stimulation and robotic neuro-rehabilitation will be assessed continuously post surgical implantation

Full Information

First Posted
October 30, 2022
Last Updated
March 13, 2023
Sponsor
National Neuroscience Institute
Collaborators
Agency for Science, Technology and Research, Tan Tock Seng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05644171
Brief Title
RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation
Acronym
RS-01
Official Title
RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Neuroscience Institute
Collaborators
Agency for Science, Technology and Research, Tan Tock Seng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Spinal Cord Injury (SCI), being a devastating diagnosis, has little to no recovery which leads to a long-standing of debilitating impairment for affected patients. The National Neuroscience Institute (NNI) Neurosurgery team, together with our collaborators, will be embarking on a new clinical pilot trial named RESTORES: RESToration of Rehabilitative function with Epidural Spinal Stimulation. This study aims to investigate the feasibility of electrical stimulation via a spinal cord stimulator (SCS), which will be implanted into the study subjects, and advanced robotic neuro-rehabilitation to aid in improving neurological function in patients diagnosed with chronic SCI. A total of 3 patients, male and female participants, above the age of 21 who have been diagnosed with the condition for more than a year will be recruited for this study over a 2-year period. Rehab sessions will take place pre and post-surgical implant, assessing subject improvements.
Detailed Description
Motor complete SCI is defined as American Spinal Injury Association (ASIA) impairment Grade A or B, with no motor function preserved below the level of injury. This in-turn results in significant catastrophic dysfunction and disability to the individual's physical and mental health, reducing quality of life and increasing caregiver burden which translates to high socioeconomic costs. The current treatments for chronic SCI involves aggressive rehabilitation to maximize residual neurological function and devices to compensate for neurological loss. However, neurological improvement is dismal, with 94.4% of patients demonstrating no neurological improvement 5-years post-injury. Experimental and electrophysiological observations revealed that spinal networks have the capacity to generate basic locomotor rhythmicity without supraspinal input to the cord. SCS, consisting of a small array of electrodes surgically implanted into the spinal epidural space stimulates afferent sensory pathways in specific patterns to drive voluntary and autonomically controlled motor responses. Activity-based training in conjunction with SCS has been shown to bolster neuroplasticity and recovery caudal to the injury site. The investigators aim to deliver epidural spinal stimulation via an implanted SCS and together with personalized advanced neuro-rehabilitation to study the improvement of neurological function after chronic SCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spinal Cord Injury
Keywords
Spinal cord injury, Epidural spinal stimulation, Implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with motor complete chronic spinal cord injury
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
RESToration Of Rehabilitative function with Epidural spinal Stimulation
Intervention Description
Three patients with chronic motor SCI will be recruited in total for this study. The recruited patients will not be randomized nor blinded due to the nature of this study. Pre-op rehabilitation session will take place over 4 weeks. 1 month post-surgical implants, patients will undergo 24 weeks of rehabilitation. The training sessions may continue to take place after the stipulated 24 weeks as long the electrode remains implanted, and the patient is available.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events assessed by CTCAE v5.0
Description
The adverse events in patient's with proposed surgical implantation and robotic neuro-rehabilitation during the course of study will be assessed. Particularly, during the first 6 months of the study and post implantation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assessing the improvement in motor outcomes post surgical implantation
Description
Volitional control including independent locomotion with epidural spinal stimulation and robotic neuro-rehabilitation will be assessed to check for improvement in motor functions. This assessment will be done during rehabilitation session where the post-surgical movement results will be compared against the pre-surgical results for better understanding and study.
Time Frame
2 years
Title
Assessing autonomic function post surgical implantation
Description
The improvement in hemodynamic, bowel and bladder control with epidural spinal stimulation and robotic neuro-rehabilitation will be assessed continuously post surgical implantation
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
⦁ Inclusion Criteria For inclusion in the study, the potential patient has to fulfil all of the following criteria: 21 years old and older Chronic (greater than one year) motor complete (AIS classification A or B) SCI Spinal injury between the levels of Thoracic 2 (T2) to Lumbar 1 (L1) Segmental reflexes that remain functional below the level of lesion 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: Significant medical co-morbidities that would significantly increase the risk of the operation Severe dysautonomia with systolic blood pressure fluctuation less than 50 or more than 200mmHg on tilt table testing Painful musculoskeletal dysfunction, contractures, unhealed fractures, pressure sores, severe spasticity, and osteoporosis Significant psychological issues or ongoing drug abuse Pregnancy and lactating patients Progressive spinal cord disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Rui Wan, MBBS
Phone
63577538
Email
wan.kai.rui@singhealth.com
Facility Information:
Facility Name
National Neuroscience Institute
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Rui Wan, MBBS
Phone
63577538
Email
wan.kai.rui@singhealth.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
15520976
Citation
Kirshblum S, Millis S, McKinley W, Tulsky D. Late neurologic recovery after traumatic spinal cord injury. Arch Phys Med Rehabil. 2004 Nov;85(11):1811-7. doi: 10.1016/j.apmr.2004.03.015.
Results Reference
background
PubMed Identifier
15124000
Citation
Minassian K, Jilge B, Rattay F, Pinter MM, Binder H, Gerstenbrand F, Dimitrijevic MR. Stepping-like movements in humans with complete spinal cord injury induced by epidural stimulation of the lumbar cord: electromyographic study of compound muscle action potentials. Spinal Cord. 2004 Jul;42(7):401-16. doi: 10.1038/sj.sc.3101615.
Results Reference
background
PubMed Identifier
17285186
Citation
Lim PA, Tow AM. Recovery and regeneration after spinal cord injury: a review and summary of recent literature. Ann Acad Med Singap. 2007 Jan;36(1):49-57.
Results Reference
background
PubMed Identifier
17343947
Citation
Minassian K, Persy I, Rattay F, Pinter MM, Kern H, Dimitrijevic MR. Human lumbar cord circuitries can be activated by extrinsic tonic input to generate locomotor-like activity. Hum Mov Sci. 2007 Apr;26(2):275-95. doi: 10.1016/j.humov.2007.01.005. Epub 2007 Mar 6.
Results Reference
background
PubMed Identifier
21091048
Citation
Teo SH, Sew S, Backman C, Forwell S, Lee WK, Chan PL, Dean E. Health of people with spinal cord injury in Singapore: implications for rehabilitation planning and implementation. Disabil Rehabil. 2011;33(15-16):1460-74. doi: 10.3109/09638288.2010.533812. Epub 2010 Nov 20.
Results Reference
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RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation

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