Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04883463
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2020-11-24
Brief Title:
Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 1 study of safety and feasibility of cervical spinal cord stimulator implantation in cervical SCI subjects who are ventilator dependent The Investigators will be focusing on the safety and feasibility of this approach Participants may qualify for the study if they are male or female 18-75 years old are at least 1 year after original injury have injury at C2 to C7 level and dependent on mechanical ventilation to help them breathe Additionally they need to be able to attend up to twice weekly testing sessions for up to 21 months
Detailed Description:
There are five main phases to this study The first phase is baseline testing second phase is temporary implant third phase is post-temporary implant mappingtreatment fourth phase is permanent implant and fifth phase is post-permanent implant treatment During each of the three phases subjects will have twice weekly laboratory testing sessions and daily home training sessions As this is a feasibility study the phases are designed to select for subjects that will be most responsive and will benefit from this strategy
Phase 1 Baseline testingtraining up to 6 months UCLA Semel Institute for Neuroscience and Human Behavior the purpose of which is to ensure that each subject begins with the full benefits achievable by standard rehabilitative respiratory therapy and has stable baseline of function before they begin epidural stimulation 15 subjects will undergo this phase Maximum inspiratory and expiratory pressure resting spontaneous respiratory activity and respiratory muscle EMG will be measured during this phase Subjects on ventilator assist mode unless or until they can sustain adequate respiration on their own will be monitored via pneumotachometer for respiratory frequency changes Additionally subjects will undergo motor and sensory testing The subjects must show stable respiratory function before implantation therefore if a subject is showing small improvements at 3 months the subject will continue training until they have reached their maximal effect from training up to 6 months Subjects that show stable baseline at 3 months will proceed to Phase 2 If a subjects health worsens including non-respiratory functioning subject will be assessed by appropriate physician and testing will be held until subjects health has improved and maintains stable for at least 2 months
Phase 2 Temporary Implant 1 day 24 hours overnight stay UCLA Medical Center Santa Monica Subjects will undergo temporary stimulator implant surgery During surgery intraoperative mapping with the implant will be performed to demonstrate effective stimulation areas Up to 12 subjects with evidence of response to baseline testing will undergo this phase from the pool of 12 subjects in Phase 1 above Response to respiratory training will be based on maximal respiratory effort respiratory abilities at rest and respiratory muscle EMG Subjects will be monitored overnight following surgery as a pre-cautionary measure
Phase 3 Post-temporary implant mappingtreatment up to 10 days UCLA Semel Institute for Neuroscience and Human Behavior Respiratory ability will be assessed Respiratory rehabilitation regimen with the stimulator will be used to re-enable respiratory function Subjects will be tested daily up to 10 non-consecutive sessions in the clinic Each session will last up to 2 hours Subject will have the temporary implant for a minimum of 1 week and maximum of 2 weeks Maximal respiratory effort and resting respiratory abilities will be evaluated as well as post-implant PROMs will be assessed Once optimal parameters have been identified electrode configurations that allow subjects to manipulate their respiratory pattern will be used Subjects will be allowed to use stimulator at home daily with identified parameters with respiratory training in addition to twice weekly testing Home use will involve turning on the stimulator breathing with the ventilator The same 12 subjects from Phase 2 will undergo this phase
Phase 4 Permanent implant 1 day 24 hours overnight stay UCLA Medical Center Santa Monica Subjects will undergo stimulator implant surgery During surgery implantation of electrodes will be performed The ideal placement location will be based on previous temporary trial location Up to 10 subjects with most connectivity and evidence of response to baseline testing will undergo this phase from the pool of 12 subjects in Phase 3 above Response to respiratory training will be assessed Subjects will be monitored overnight following surgery as a pre-cautionary measure
Phase 5 Post-permanent implant mappingtreatment up to 12 months UCLA Semel Institute for Neuroscience and Human Behavior in which the electrode configurations that activate respiratory muscles will be used Respiratory rehabilitation regimen with the stimulator will be used to re-enable respiratory function 10 subjects will be tested up to twice weekly in the clinic for up to 2 hours per session Respiratory response to stimulation will be assessed Once optimal parameters have been identified electrode configurations that allow subjects to manipulate their respiratory pattern will be used Subjects will be allowed to use stimulator at home daily with identified parameters with respiratory training in addition to twice weekly testing The same 10 subjects from Phase 4 will undergo this phase
Timeline The study is a safety and feasibility trial This is a single arm implantation of permanent electrode to assess safety and early efficacy of cervical spinal epidural stimulation to improve respiratory function It is conducted over a period of up to 6 months or 21 months in 1 2 or 3 periods respectively Fig 3 Phase 1 Baseline training up to 6 months Phase 2 Temporary Trial Implant 1 day Phase 3 Post-temporary trial implant treatment up to 10 days Phase 4 Permanent Implant 1 day with up to 2 months for surgical recovery Phase 5 Post-permanent implant treatment up to 12 months Therefore 15 subjects will be involved for up to 6 months while 12 subjects will be involved for up to 7 months and 10 subjects involved for up to 21 months 18 months of testing with up to 2 months recovery
Home Use To ensure safety the ventilator will provide support for the patient during home use with stimulator turned on just as it does when epidural stimulation is not on The patient will not be completely disconnected to the ventilator unless independence from the ventilator is achieved through a gradual and very closely supervised weaning process in which the patient will demonstrate stable O2 saturation and adequate minute ventilation through the stages of weaning Weaning and evidence of improved respiratory muscle function will consist of gradually reducing the level of support delivered by the ventilator while requiring that as weaning occurs the patient maintains stable minute ventilation on his own
To ensure safety these weaning maneuvers will be conducted only with respiratory therapist being present and an AMBU bag with supplemental O2 will be available Additionally for safety the caregiver will obtain heart rate blood pressure temperature at 15 min intervals and O2 saturation continuously or when there is a change in the ventilator setting Additionally this will be performed only when the subject is fully conscious awake and following commands
Phase 1 Baseline testingtraining up to 6 months UCLA Semel Institute for Neuroscience and Human Behavior the purpose of which is to ensure that each subject begins with the full benefits achievable by standard rehabilitative respiratory therapy and has stable baseline of function before they begin epidural stimulation 15 subjects will undergo this phase Maximum inspiratory and expiratory pressure resting spontaneous respiratory activity and respiratory muscle EMG will be measured during this phase Subjects on ventilator assist mode unless or until they can sustain adequate respiration on their own will be monitored via pneumotachometer for respiratory frequency changes Additionally subjects will undergo motor and sensory testing The subjects must show stable respiratory function before implantation therefore if a subject is showing small improvements at 3 months the subject will continue training until they have reached their maximal effect from training up to 6 months Subjects that show stable baseline at 3 months will proceed to Phase 2 If a subjects health worsens including non-respiratory functioning subject will be assessed by appropriate physician and testing will be held until subjects health has improved and maintains stable for at least 2 months
Phase 2 Temporary Implant 1 day 24 hours overnight stay UCLA Medical Center Santa Monica Subjects will undergo temporary stimulator implant surgery During surgery intraoperative mapping with the implant will be performed to demonstrate effective stimulation areas Up to 12 subjects with evidence of response to baseline testing will undergo this phase from the pool of 12 subjects in Phase 1 above Response to respiratory training will be based on maximal respiratory effort respiratory abilities at rest and respiratory muscle EMG Subjects will be monitored overnight following surgery as a pre-cautionary measure
Phase 3 Post-temporary implant mappingtreatment up to 10 days UCLA Semel Institute for Neuroscience and Human Behavior Respiratory ability will be assessed Respiratory rehabilitation regimen with the stimulator will be used to re-enable respiratory function Subjects will be tested daily up to 10 non-consecutive sessions in the clinic Each session will last up to 2 hours Subject will have the temporary implant for a minimum of 1 week and maximum of 2 weeks Maximal respiratory effort and resting respiratory abilities will be evaluated as well as post-implant PROMs will be assessed Once optimal parameters have been identified electrode configurations that allow subjects to manipulate their respiratory pattern will be used Subjects will be allowed to use stimulator at home daily with identified parameters with respiratory training in addition to twice weekly testing Home use will involve turning on the stimulator breathing with the ventilator The same 12 subjects from Phase 2 will undergo this phase
Phase 4 Permanent implant 1 day 24 hours overnight stay UCLA Medical Center Santa Monica Subjects will undergo stimulator implant surgery During surgery implantation of electrodes will be performed The ideal placement location will be based on previous temporary trial location Up to 10 subjects with most connectivity and evidence of response to baseline testing will undergo this phase from the pool of 12 subjects in Phase 3 above Response to respiratory training will be assessed Subjects will be monitored overnight following surgery as a pre-cautionary measure
Phase 5 Post-permanent implant mappingtreatment up to 12 months UCLA Semel Institute for Neuroscience and Human Behavior in which the electrode configurations that activate respiratory muscles will be used Respiratory rehabilitation regimen with the stimulator will be used to re-enable respiratory function 10 subjects will be tested up to twice weekly in the clinic for up to 2 hours per session Respiratory response to stimulation will be assessed Once optimal parameters have been identified electrode configurations that allow subjects to manipulate their respiratory pattern will be used Subjects will be allowed to use stimulator at home daily with identified parameters with respiratory training in addition to twice weekly testing The same 10 subjects from Phase 4 will undergo this phase
Timeline The study is a safety and feasibility trial This is a single arm implantation of permanent electrode to assess safety and early efficacy of cervical spinal epidural stimulation to improve respiratory function It is conducted over a period of up to 6 months or 21 months in 1 2 or 3 periods respectively Fig 3 Phase 1 Baseline training up to 6 months Phase 2 Temporary Trial Implant 1 day Phase 3 Post-temporary trial implant treatment up to 10 days Phase 4 Permanent Implant 1 day with up to 2 months for surgical recovery Phase 5 Post-permanent implant treatment up to 12 months Therefore 15 subjects will be involved for up to 6 months while 12 subjects will be involved for up to 7 months and 10 subjects involved for up to 21 months 18 months of testing with up to 2 months recovery
Home Use To ensure safety the ventilator will provide support for the patient during home use with stimulator turned on just as it does when epidural stimulation is not on The patient will not be completely disconnected to the ventilator unless independence from the ventilator is achieved through a gradual and very closely supervised weaning process in which the patient will demonstrate stable O2 saturation and adequate minute ventilation through the stages of weaning Weaning and evidence of improved respiratory muscle function will consist of gradually reducing the level of support delivered by the ventilator while requiring that as weaning occurs the patient maintains stable minute ventilation on his own
To ensure safety these weaning maneuvers will be conducted only with respiratory therapist being present and an AMBU bag with supplemental O2 will be available Additionally for safety the caregiver will obtain heart rate blood pressure temperature at 15 min intervals and O2 saturation continuously or when there is a change in the ventilator setting Additionally this will be performed only when the subject is fully conscious awake and following commands
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None