SCI - Spinal Cord Injury
Conditions
Keywords
SCI - Spinal Cord Injury, VNS - Vagus Nerve Stimulation, TPT - Targeted Plasticity Therapy
Brief summary
This study is an open label extension of the SCI EFS clinical trial (NCT04288245) that developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury. The objectives of this study are to provide continued safety assessment for the investigational ReStore system, and to gain further estimate of the effect of Vagus Nerve Stimulation (VNS) with rehabilitative exercises in four different tracks - upper limb (UL), lower limb (LL), bladder control (BC), and sensory (SY) for participants with chronic SCI (Spinal Cord Injury).
Detailed description
A prospective, multi-center, non-randomized, open label extension of the SCI EFS trial (NCT04288245) participants implanted with the investigational ReStore Device for VNS Therapy. Following the completion of Phase 2 of the SCI EFS study, participants can enroll to one of the four tracks. Under each track, participants will undergo up to 36 sessions of rehabilitative exercises self-paced by participants with targeted completion of 3 sessions per week. Evaluations will be administered at the beginning and end of each track (additional progress checks may be conducted, as required by the staff) to monitor participant progress. Upon completion of a track, participants can choose to re-enroll in the same or a different track. Adverse events will be documented and assessed throughout the trial.
Interventions
DEVICEActive VNS
Subjects will receive active VNS paired with track-specific rehabilitation exercises.
Sponsors
The University of Texas at Dallas
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a non-randomized, open-label, adaptive, optional extension study model
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Completed phase 2 of the SCI EFS study (NCT04288245) 2. Willing to comply with procedures for the entire duration of the study (study protocol compliance) 3. Provision of signed and dated informed consent form 4. Access to reliable communication and internet connections (for those intending to complete sessions at home) 5. Has not had their VNS device explanted General
Exclusion criteria
1. Concurrent participation in another active interventional trial or participation in an active interventional trial within 7 days prior to enrollment 2. Any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator 3. Any condition which would preclude adequate evaluation of device's safety and performance in the judgment of the Investigator 4. Individuals who have a change in medical condition or health status such that they would meet the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (device safety) | Starting at session 1 on week 1, throughout the study up to last session 36 on week 15. | UL, LL, BC and SY - Review of adverse events reported throughout the trial will be used to inform the potential risks associated with the ReStore System |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Jebsen-Taylor Hand Function (JTHF) Score | At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14. | UL only - Determine whether VNS therapy improves Jebsen-Taylor Hand Function (JTHF) score compared to baseline. This measure is not a scale. Each item is timed from 0 to 120 seconds. Lower/faster values are better. |
| Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) | At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14. | UL only - Determine whether VNS therapy improves the GRASSP score compared to baseline. This scale is from 0 to 116 points. Higher scores are better. |
| Force & Range of motion | At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14. | UL only - Determine whether VNS therapy improves force and range of motion in the hand and wrist compared to baseline. |
| 6 Meter Walk Test (6MWT) | At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14. | LL only - Determine whether VNS therapy improves six-minute walking test (6MWT) score compared to baseline. This measure is not a scale. Higher distance covered is better. |
| 10 Meter Walk Test (10MWT) | At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14. | LL only - Determine whether VNS therapy improves 10-Meter Walk Test (10-MWT) score compared to baseline. This measure is not a scale. Lower time to complete is better. |
| Walking Index for Spinal Cord Injury II (WISCI II) | At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14. | LL only - Determine whether VNS therapy improves Walking Index for Spinal Cord Injury II (WISCI II) score compared to baseline. This scale is from 0-20. Higher scores are better. |
| Berg's Balance Scale (BBG) | At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14. | LL only - Determine whether VNS therapy improves Berg's Balance Scale (BBG) score compared to baseline. This scale is from 0 to 56. Higher scores are better. |
| Timed Up-and Go (TUG)Test | At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14. | LL only - Determine whether VNS therapy improves Timed Up-and Go (TUG)Test score compared to baseline. This measure is not a scale. Lower time to complete is better. |
| Lower Extremity Motor Score (LEMS) | At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14. | LL only - Determine whether VNS therapy improves Lower Extremity Motor Score (LEMS) compared to baseline. This scale is from 0 to 50. Higher scores are better. |
| Voiding efficiency | At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13. | BC only - Estimate the shift in voiding efficiency through bladder ultrasonography assessment following active VNS |
| Bladder volume capacity | At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13. | BC only - Estimate the shift in bladder volume capacity during bladder ultrasonography assessment following active VNS |
| Postvoid residual volume (PVR) | At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13. | BC only - Estimate the shift in PVR during bladder ultrasonography assessment following active VNS |
| Neurogenic Bladder Symptom Score (NBSS) questionnaire | At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13. | BC only - Estimate the shift in NBSS score following active VNS. This scale is from 0 to 78. Lower scores are better. |
| Urinary Distress Inventory (UDI-6), short form questionnaire | At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13. | BC only - Estimate the shift in the UDI-6 questionnaire score following active VNS. This scale is from 0 to 18. Lower scores are better. |
| Two - Point Discrimination | At session 1 on week 1, on week 8, week 12 and as needed during intervening sessions from week 2 to 7. | SY only - Determine whether VNS therapy improves Two-Point Discrimination (2PD) score compared to baseline. This measure is not a scale but the ability to feel two separate points of touch on the skin instead of just one. It's a sensory test used in neurological exams to assess the density and health of nerve innervation in a specific area of the body. The test involves determining the smallest distance between two points that a person can still perceive as two separate stimuli. |
| Tactile Discrimination Test (TDT) | At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7. | SY only- Determine whether VNS therapy improves Tactile Discrimination Test (TDT) score compared to baseline. This scale is from 0 to 25 points. Higher scores are better. |
| Semmes-Weinstein Monofilaments (SWM) | At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7. | SY only - Determine whether VNS therapy improves Semmes-Weinstein Monofilaments (SWM) test score compared to baseline. This measure is not a scale but a test to assess a person's light touch sensation using a set of filaments of different thickness to identify loss of protective sensation in areas like feet or hands. The level of the filament required to elicit a response provides a measurement of the patient's sensory threshold. Thinner filament indicates better sensory function. |
| US-Nottingham Sensory Assessment (US-NSA) | At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7. | SY only - Determine whether VNS therapy improves US-Nottingham Sensory Assessment (US-NSA) score compared to baseline. This assessment is a scale ranging from 0 to 92 for the upper extremity, and 0 to 172 for the combined upper and lower extremities. Higher scores indicate better sensory function. |
| International SCI Pain Basic Data | At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7. | SY only- Determine whether VNS therapy can reduce pain severity and improve patient-reported outcomes of the International SCI Pain Basic Data Set, compared to baseline measures. This measure uses a numeric rating scale from 0 to 10, where 0 indicates no pain. Lower scores indicate lower pain intensity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJane Wigginton
The University of Texas at Dallas
PRINCIPAL_INVESTIGATORRobert Rennaker
The University of Texas at Dallas
PRINCIPAL_INVESTIGATORRita Hamilton
Baylor Scott and White Institute for Rehabilitation
Outcome results
None listed