Trial Outcomes & Findings for Effect of Epidural Stimulation on Muscle Activation and Sensory Perception (NCT NCT04157400)
NCT ID: NCT04157400
Last Updated: 2023-02-15
Results Overview
During intraoperative testing of varying stimulation parameters, the research team plans to collect evoked potentials via electromyography (EMG) as the primary outcome for step one. Evoked potential amplitude, recorded at specific muscles of interest, will be collected for nerve root activation threshold. The research team plans to look at musculature receiving innervation from varying levels of the spinal cord in order to determine any difference among stimulation type regarding nerve root isolation.
COMPLETED
NA
5 participants
Data collection for step one is expected to last approximately fifteen minutes during the spinal cord stimulation surgery.
2023-02-15
Participant Flow
Participant milestones
| Measure |
Epidural Spinal Cord Stimulation
Subjects with chronic pain that have been scheduled to receive spinal cord simulators for standard of care treatment.
Intraoperative Parameter Testing: Step 1: Recording and stimulation of spinal potentials during insertion of epidural spinal stimulator paddle
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|---|---|
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Overall Study
STARTED
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5
|
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Overall Study
COMPLETED
|
1
|
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Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Epidural Spinal Cord Stimulation
Subjects with chronic pain that have been scheduled to receive spinal cord simulators for standard of care treatment.
Intraoperative Parameter Testing: Step 1: Recording and stimulation of spinal potentials during insertion of epidural spinal stimulator paddle
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Effect of Epidural Stimulation on Muscle Activation and Sensory Perception
Baseline characteristics by cohort
| Measure |
Epidural Spinal Cord Stimulation
n=5 Participants
Subjects with chronic pain that have been scheduled to receive spinal cord simulators for standard of care treatment.
Intraoperative Parameter Testing: Step 1: Recording and stimulation of spinal potentials during insertion of epidural spinal stimulator paddle
Once the epidural paddle is placed, study procedures will begin by connecting the terminals of the paddle to an electrophysiological recording device for signal amplification and filtering. Using this recording setup, motor evoked potential (MEP) and somatosensory evoked potential (SSEP) protocols will be performed to determine motor and sensory thresholds, respectively. Next, the surgical procedure will resume and after the implantable pulse generator (IPG) has been placed, study procedures will begin again and include activation of both low-frequency tonic stimulation (LFTS) and high-frequency burst stimulation (HFBS) patterns from the inserted paddle while recording EMG signals.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Data collection for step one is expected to last approximately fifteen minutes during the spinal cord stimulation surgery.Population: Three participants did not have sufficient data to analyze - 2 of the patients did not undergo the 2nd part of the protocol and 1 patient decided not to have surgery. One patient withdrew from the study prior to undergoing surgery.
During intraoperative testing of varying stimulation parameters, the research team plans to collect evoked potentials via electromyography (EMG) as the primary outcome for step one. Evoked potential amplitude, recorded at specific muscles of interest, will be collected for nerve root activation threshold. The research team plans to look at musculature receiving innervation from varying levels of the spinal cord in order to determine any difference among stimulation type regarding nerve root isolation.
Outcome measures
| Measure |
Epidural Spinal Cord Stimulation
n=1 Participants
Subjects with chronic pain that have been scheduled to receive spinal cord simulators for standard of care treatment.
|
|---|---|
|
Electromyography Response Amplitude
Vastus Lateralis (EMG); 40 Hz LFTS (Stimulation)
|
33.7 microvolts (mV)
Standard Error 0.7
|
|
Electromyography Response Amplitude
Vastus Lateralis (EMG); 600 Hz HFBS, 40 Hz interburst (Stimulation)
|
122.1 microvolts (mV)
Standard Error 2.5
|
|
Electromyography Response Amplitude
Tibialis Anterior (EMG); 40 Hz LFTS (Stimulation)
|
39.2 microvolts (mV)
Standard Error 0.8
|
|
Electromyography Response Amplitude
Soleus (EMG); 40 Hz LFTS (Stimulation)
|
90.4 microvolts (mV)
Standard Error 1.2
|
|
Electromyography Response Amplitude
Soleus (EMG); 600 Hz HFBS, 40 Hz interburst (Stimulation)
|
143.0 microvolts (mV)
Standard Error 2.6
|
|
Electromyography Response Amplitude
Tibialis Anterior (EMG); 600 Hz HFBS, 40 Hz interburst (Stimulation)
|
69.7 microvolts (mV)
Standard Error 0.9
|
PRIMARY outcome
Timeframe: Data collection for step two is expected to last approximately two hours.Population: Three participants did not have sufficient data to analyze - 2 of the patients did not undergo the 2nd part of the protocol and 1 patient decided not to have surgery. One patient withdrew from the study prior to undergoing surgery.
Proprioception signaling will be tested using a Biodex machine that can apply passive flexion/extension at the knee while the subject reports 1) Feeling of movement and 2) Direction of movement. Specific data of interest will be the amount of degrees of flexion/extension of the knee that have occurred before the subject perceives the movement, which is reflective of proprioceptive signaling. Testing while experiencing varying types of stimulation will yield important information regarding physiological sensory modulation from the stimulator. The research team plans to use a repeated measures two-way ANOVA with epidural stimulation type and current amplitude of above and below EMG activation threshold to investigate effects on proprioception detection signaling.
Outcome measures
| Measure |
Epidural Spinal Cord Stimulation
n=1 Participants
Subjects with chronic pain that have been scheduled to receive spinal cord simulators for standard of care treatment.
|
|---|---|
|
Proprioception Testing
Degrees of passive knee flexion / extension before detection: No stimulation
|
3.93 Degrees of Flexion / Extension
Standard Error 0.35
|
|
Proprioception Testing
Degrees of passive knee flexion / extension before detection: 40 Hz LFTS
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6.71 Degrees of Flexion / Extension
Standard Error 0.63
|
|
Proprioception Testing
Degrees of passive knee flexion / extension before detection: 600 Hz HFBS, 40 Hz interburst
|
4.52 Degrees of Flexion / Extension
Standard Error 0.21
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PRIMARY outcome
Timeframe: Data collection for step three is expected to last approximately two hours.Population: Three participants did not have sufficient data to analyze - 2 of the patients did not undergo the 2nd part of the protocol and 1 patient decided not to have surgery. One patient withdrew from the study prior to undergoing surgery.
During gait analysis, the research team plans to collect surface electromyography (EMG) signals of lower extremity musculature to measure activation synergies and amplitudes. Segments of EMG that are recorded during walking will be analyzed with an algorithm that yields hierarchal complexities representing muscle synergies known as EMG moduling. The research team plans to use a two-way repeated measures ANOVA model in order to investigate the varying differences in stimulation type and effect on EMG module complexity to investigate the relationship between sensory pathway modulation and motor control during functional task.
Outcome measures
| Measure |
Epidural Spinal Cord Stimulation
n=1 Participants
Subjects with chronic pain that have been scheduled to receive spinal cord simulators for standard of care treatment.
|
|---|---|
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Change in Electromyography Microvoltage Signal During Walking
EMG Module Complexity During No Stimulation
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4.1 microvolts (mV)
|
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Change in Electromyography Microvoltage Signal During Walking
EMG Module Complexity During 40 Hz LFTS
|
2.6 microvolts (mV)
|
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Change in Electromyography Microvoltage Signal During Walking
EMG Module Complexity During 600 Hz HFBS, 40 Hz interburst
|
3.2 microvolts (mV)
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Adverse Events
Epidural Spinal Cord Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place