Trial Outcomes & Findings for Intraoperative Neuromonitoring Recording With a Novel SCS Paddle (NCT NCT05045625)

NCT ID: NCT05045625

Last Updated: 2023-03-01

Results Overview

Patients rate their pain on a scale from 0-10; 0 being not in pain and 10 being worst pain imaginable. A higher score indicates worse outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-03-01

Participant Flow

Participant milestones

Measure	Study Group Twelve patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care HD Study Electrode: The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.
Overall Study STARTED	12
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

Study Group Twelve patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care HD Study Electrode: The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.

Overall Study Lost to Follow-up

3

Baseline Characteristics

Intraoperative Neuromonitoring Recording With a Novel SCS Paddle

Baseline characteristics by cohort

Measure	Study Group n=12 Participants Twelve patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care HD Study Electrode: The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.
Age, Continuous	52.75 years STANDARD_DEVIATION 14.75 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	12 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

PRIMARY outcome

Timeframe: 3 months

Patients rate their pain on a scale from 0-10; 0 being not in pain and 10 being worst pain imaginable. A higher score indicates worse outcome.

Outcome measures

Measure

Study Group n=9 Participants Twelve patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care HD Study Electrode: The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.

Numeric Rating Scale (NRS)

5.333333333 score on a scale Standard Deviation 2.115700942

SECONDARY outcome

Timeframe: 3 month

Patients select words that describe their pain. There are a total of 15 words. A higher score (more words selected) indicates worse outcome with a range from 0-15.

Outcome measures

Measure

Study Group n=9 Participants Twelve patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care HD Study Electrode: The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.

McGill Pain Questionnaire (MPQ)

8.222222222 score on a scale Standard Deviation 2.886751346

SECONDARY outcome

Timeframe: 3 months

This is a multiple choice style scale where patients are presented with an activity and asked to select a description which best matches their ability to perform that activity. Multiple choice options are then scored on a scale from 0-5; where 0 is no issues performing the activity and 5 is cannot perform activity. A higher score indicates worse outcome. The range in scores is from 0-100.

Outcome measures

Measure

Study Group n=9 Participants Twelve patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care HD Study Electrode: The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.

Oswestry Disability Index (ODI)

50 units on a scale Standard Deviation 17.13086882

SECONDARY outcome

Timeframe: 3 months

Patients are presented with a series of statements and they are asked to rate on a scale from 0-4, how often these statements apply to them when they are in pain. 0= never and 4= always. A higher score indicates worse outcome. Scores range from 0-52.

Outcome measures

Measure

Study Group n=9 Participants Twelve patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care HD Study Electrode: The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.

Pain Catastrophizing Scale (PCS)

18 units on a scale Standard Deviation 12.43267584

SECONDARY outcome

Timeframe: 3 months

This is a multiple choice style scale where patients are asked to select a statement related to a feeling of sadness or a component of depression. Multiple choice options are then scored on a scale from 0-3; where 0 is they do not feel that way and 3 is they do feel that way. A higher score indicates worse outcome. Scores range from 0-63

Outcome measures

Measure

Study Group n=9 Participants Twelve patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care HD Study Electrode: The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.

Beck Depression Index (BDI)

14.33333333 units on a scale Standard Deviation 12.35198075

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Study Group n=12 participants at risk Twelve patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care HD Study Electrode: The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.

Surgical and medical procedures intraoperative

8.3% 1/12 • Number of events 1 • 1 year

Additional Information

Clinical Research Coordinator

Albany Medical College

Phone: 518-262-2367

Email: khazeno@amc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place