Trial Outcomes & Findings for Medtronic Closed-Loop Spinal Cord Stimulation System (NCT NCT05177354)

Last Updated: 2025-11-05

Results Overview

The primary outcome is the proportion of low-back and/or leg pain subjects whose average overstimulation intensity score with Closed Loop On is less than their average overstimulation intensity score with Closed Loop Off. During in-clinic testing, subjects perform protocol prescribed activities and rate the intensity of the sensations on a 5-point Likert scale with both Closed Loop On and Off. The average overstimulation intensity scores within each subject are calculated separately for Closed Loop On and Off, and the proportion of subjects with a lower average overstimulation intensity score during Closed Loop On compared to their overstimulation intensity score during Closed Loop Off is calculated with a one-sided 97.5% lower bound.

Recruitment status

COMPLETED

Study phase

Target enrollment

94 participants

Primary outcome timeframe

30 days from device activation

Results posted on

2025-11-05

Participant Flow

94 subjects were enrolled. 19 exited prior to the SCS trial. 75 started the trial with 2 subjects not completing the trial and 4 subjects experiencing an unsuccessful trial. Of the 69 that had a successful trial, 9 exited before implant and 60 were implanted. All implanted subjects received SCS therapy following device activation, and subjects with clear and measurable Evoked Compound Action Potentials (ECAPs) had the option to turn the closed loop feature On.

Participant milestones

Participant milestones
Measure	All Implanted Subjects Enrolled subjects who are implanted with a spinal cord stimulation system. Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with closed loop feature capabilities.
Implant to 30-day Visit STARTED	60
Implant to 30-day Visit COMPLETED	57
Implant to 30-day Visit NOT COMPLETED	3
30-day Visit to 3-Month Visit STARTED	57
30-day Visit to 3-Month Visit COMPLETED	56
30-day Visit to 3-Month Visit NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	All Implanted Subjects Enrolled subjects who are implanted with a spinal cord stimulation system. Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with closed loop feature capabilities.
Implant to 30-day Visit Physician Decision	1
Implant to 30-day Visit Withdrawal by Subject	1
Implant to 30-day Visit Lack of compliance to the protocol including phone calls & optimisation visits.	1
30-day Visit to 3-Month Visit Adverse Event	1

Baseline Characteristics

Medtronic Closed-Loop Spinal Cord Stimulation System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Implanted Subjects n=60 Participants Enrolled subjects who are implanted with a spinal cord stimulation system. Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with closed loop feature capabilities.
Years Since Onset of Pain	10.1 years STANDARD_DEVIATION 9.69 • n=15 Participants
Age, Continuous	57.9 years STANDARD_DEVIATION 14.08 • n=15 Participants
Sex: Female, Male Female	27 Participants n=15 Participants
Sex: Female, Male Male	33 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants
Race (NIH/OMB) Asian	2 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	1 Participants n=15 Participants
Race (NIH/OMB) White	47 Participants n=15 Participants
Race (NIH/OMB) More than one race	10 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants
Primary Location of Pain Low-Back and/or Leg Pain	57 Participants n=15 Participants
Primary Location of Pain Upper Limb Pain	3 Participants n=15 Participants
Primary Indication Degenerative Disk Disease	23 Participants n=15 Participants
Primary Indication Failed Back Syndrome	20 Participants n=15 Participants
Primary Indication Radicular Pain Syndrome	5 Participants n=15 Participants
Primary Indication Post Laminectomy Pain	4 Participants n=15 Participants
Primary Indication Complex Regional Pain Syndrome	4 Participants n=15 Participants
Primary Indication Unsuccessful Disk Surgery	3 Participants n=15 Participants
Primary Indication Peripheral Causalgia	1 Participants n=15 Participants

PRIMARY outcome

Timeframe: 30 days from device activation

Population: The pre-specified Primary Analysis Set includes the first 28 low-back and/or leg pain subjects within the All Implanted Subjects Arm with clear and measurable Evoked Compound Action Potentials (ECAPs) who completed in-clinic testing at the 30-day visit. Of the 60 implanted subjects, 2 missed the 30-day visit, 55 completed the 30-day visit, 50 had low-back and/or leg pain and clear and measurable ECAPs, and the first 28 of these subjects are included in the analysis for this objective.

Outcome measures

Outcome measures
Measure	All Implanted Subjects n=28 Participants Enrolled subjects who are implanted with a spinal cord stimulation system. Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with closed loop feature capabilities.
Reduction in Overstimulation Sensation	25 Participants

SECONDARY outcome

Timeframe: 3 months from device activation

Population: All implanted subjects with low-back and/or leg pain who have data at baseline and the 3-month visit. As all subjects were implanted with a spinal cord stimulation system with closed loop feature capabilities, the analysis was pre-specified in the statistical analysis plan to report the combined responder rate for these subjects with data at baseline and the 3-month visit, regardless of whether in-clinic testing of the closed loop feature had been conducted at the 30-day visit.

Responder rate defined as a reduction in Overall (back/leg) pain VAS of at least 50%.

Outcome measures

Outcome measures
Measure	All Implanted Subjects n=51 Participants Enrolled subjects who are implanted with a spinal cord stimulation system. Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with closed loop feature capabilities.
Responder Rate for Treatment of Overall Pain	44 Participants

SECONDARY outcome

Timeframe: 3 months from device activation

Population: All implanted subjects with low-back pain (baseline VAS ≥ 60mm) who have data at baseline and the 3-month visit. As all subjects were implanted with a spinal cord stimulation system with closed loop feature capabilities, the analysis was pre-specified in the statistical analysis plan to report the combined responder rate for these subjects with data at baseline and the 3-month visit, regardless of whether in-clinic testing of the closed loop feature had been conducted at the 30-day visit.

Responder rate defined as a reduction in back pain VAS of at least 50%.

Outcome measures

Outcome measures
Measure	All Implanted Subjects n=43 Participants Enrolled subjects who are implanted with a spinal cord stimulation system. Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with closed loop feature capabilities.
Responder Rate for Treatment of Low-back Pain	38 Participants

SECONDARY outcome

Timeframe: 3 months from device activation

Population: All implanted subjects with leg pain (baseline VAS ≥ 60mm) who have data at baseline and the 3-month visit. As all subjects were implanted with a spinal cord stimulation system with closed loop feature capabilities, the analysis was pre-specified in the statistical analysis plan to report the combined responder rate for these subjects with data at baseline and the 3-month visit, regardless of whether in-clinic testing of the closed loop feature had been conducted at the 30-day visit.

Responder rate defined as a reduction in leg pain VAS of at least 50%.

Outcome measures

Outcome measures
Measure	All Implanted Subjects n=41 Participants Enrolled subjects who are implanted with a spinal cord stimulation system. Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with closed loop feature capabilities.
Responder Rate for Treatment of Leg Pain	30 Participants

Adverse Events

All Implanted Subjects

Serious events: 10 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Implanted Subjects n=60 participants at risk Enrolled subjects who are implanted with a spinal cord stimulation system. Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with closed loop feature capabilities.
Infections and infestations Medical device site infection	5.0% 3/60 • Number of events 3 • From Implant through 3 months post activation All device/therapy-related adverse events (AEs) related to the implanted spinal cord stimulation (SCS) system, accessories, surgical procedures, and therapy were collected. Non-serious, non-device/therapy-related AEs were not collected. All serious AEs were collected regardless of device/therapy-relatedness. AEs were not collected separately by whether the closed loop feature was On or Off; it was pre-specified to report the AE rates through the 3-month visit for all implanted subjects.
Cardiac disorders Coronary artery occlusion	1.7% 1/60 • Number of events 1 • From Implant through 3 months post activation All device/therapy-related adverse events (AEs) related to the implanted spinal cord stimulation (SCS) system, accessories, surgical procedures, and therapy were collected. Non-serious, non-device/therapy-related AEs were not collected. All serious AEs were collected regardless of device/therapy-relatedness. AEs were not collected separately by whether the closed loop feature was On or Off; it was pre-specified to report the AE rates through the 3-month visit for all implanted subjects.
General disorders Stent-graft endoleak	1.7% 1/60 • Number of events 1 • From Implant through 3 months post activation All device/therapy-related adverse events (AEs) related to the implanted spinal cord stimulation (SCS) system, accessories, surgical procedures, and therapy were collected. Non-serious, non-device/therapy-related AEs were not collected. All serious AEs were collected regardless of device/therapy-relatedness. AEs were not collected separately by whether the closed loop feature was On or Off; it was pre-specified to report the AE rates through the 3-month visit for all implanted subjects.
General disorders Medical device site pain	1.7% 1/60 • Number of events 1 • From Implant through 3 months post activation All device/therapy-related adverse events (AEs) related to the implanted spinal cord stimulation (SCS) system, accessories, surgical procedures, and therapy were collected. Non-serious, non-device/therapy-related AEs were not collected. All serious AEs were collected regardless of device/therapy-relatedness. AEs were not collected separately by whether the closed loop feature was On or Off; it was pre-specified to report the AE rates through the 3-month visit for all implanted subjects.
General disorders Medical device site hematoma	1.7% 1/60 • Number of events 1 • From Implant through 3 months post activation All device/therapy-related adverse events (AEs) related to the implanted spinal cord stimulation (SCS) system, accessories, surgical procedures, and therapy were collected. Non-serious, non-device/therapy-related AEs were not collected. All serious AEs were collected regardless of device/therapy-relatedness. AEs were not collected separately by whether the closed loop feature was On or Off; it was pre-specified to report the AE rates through the 3-month visit for all implanted subjects.
Infections and infestations Staphylococcal bacteremia	1.7% 1/60 • Number of events 1 • From Implant through 3 months post activation All device/therapy-related adverse events (AEs) related to the implanted spinal cord stimulation (SCS) system, accessories, surgical procedures, and therapy were collected. Non-serious, non-device/therapy-related AEs were not collected. All serious AEs were collected regardless of device/therapy-relatedness. AEs were not collected separately by whether the closed loop feature was On or Off; it was pre-specified to report the AE rates through the 3-month visit for all implanted subjects.
Injury, poisoning and procedural complications Skin laceration	1.7% 1/60 • Number of events 1 • From Implant through 3 months post activation All device/therapy-related adverse events (AEs) related to the implanted spinal cord stimulation (SCS) system, accessories, surgical procedures, and therapy were collected. Non-serious, non-device/therapy-related AEs were not collected. All serious AEs were collected regardless of device/therapy-relatedness. AEs were not collected separately by whether the closed loop feature was On or Off; it was pre-specified to report the AE rates through the 3-month visit for all implanted subjects.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.7% 1/60 • Number of events 1 • From Implant through 3 months post activation All device/therapy-related adverse events (AEs) related to the implanted spinal cord stimulation (SCS) system, accessories, surgical procedures, and therapy were collected. Non-serious, non-device/therapy-related AEs were not collected. All serious AEs were collected regardless of device/therapy-relatedness. AEs were not collected separately by whether the closed loop feature was On or Off; it was pre-specified to report the AE rates through the 3-month visit for all implanted subjects.
Nervous system disorders Transient ischemic attack	1.7% 1/60 • Number of events 1 • From Implant through 3 months post activation All device/therapy-related adverse events (AEs) related to the implanted spinal cord stimulation (SCS) system, accessories, surgical procedures, and therapy were collected. Non-serious, non-device/therapy-related AEs were not collected. All serious AEs were collected regardless of device/therapy-relatedness. AEs were not collected separately by whether the closed loop feature was On or Off; it was pre-specified to report the AE rates through the 3-month visit for all implanted subjects.
Respiratory, thoracic and mediastinal disorders Dysponea	1.7% 1/60 • Number of events 1 • From Implant through 3 months post activation All device/therapy-related adverse events (AEs) related to the implanted spinal cord stimulation (SCS) system, accessories, surgical procedures, and therapy were collected. Non-serious, non-device/therapy-related AEs were not collected. All serious AEs were collected regardless of device/therapy-relatedness. AEs were not collected separately by whether the closed loop feature was On or Off; it was pre-specified to report the AE rates through the 3-month visit for all implanted subjects.

Other adverse events

Other adverse events
Measure	All Implanted Subjects n=60 participants at risk Enrolled subjects who are implanted with a spinal cord stimulation system. Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with closed loop feature capabilities.
General disorders Medical device site pain	5.0% 3/60 • Number of events 3 • From Implant through 3 months post activation All device/therapy-related adverse events (AEs) related to the implanted spinal cord stimulation (SCS) system, accessories, surgical procedures, and therapy were collected. Non-serious, non-device/therapy-related AEs were not collected. All serious AEs were collected regardless of device/therapy-relatedness. AEs were not collected separately by whether the closed loop feature was On or Off; it was pre-specified to report the AE rates through the 3-month visit for all implanted subjects.

Additional Information

Nancy McClelland

Medtronic Neuromodulation

Phone: 1-800-633-8766

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Institution must ensure the Discloser gives a copy of any proposed Publication drafted by them and/or Personnel involved in the conduct of the Study to the Sponsor at least 40 days The Sponsor may do one of the following 1. provide optional comments 2. request delay for no more than 120 days to file patent applications or take other measures to preserve or secure its IP, Institution must abide by request 3. request removal of Confidential Information from the Publication
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Restriction type: OTHER