Research report
A research report is the sourced material a domain
dossier is synthesized from — generated on a plan and a cadence, one topic per file.
A report carries no confidence tags. Its bracketed markers say who might have
an incentive to shade a line; none of them says anyone checked it. To reach a score, a line has
to be drafted onto a candidate as unverified and pass the Verifier or the
Corroborator, like everything else.
Section reference-products · Version 2026-09-30 · Cadence quarterly · Evidence class mixed · Sources 24 · Supersedes none
Domain: stress-urinary-incontinence · Scope: Analog cases for idea-001 B1 — any condition in which a sponsor recovered a microvolt
Sourcing: Rests on PubMed abstracts of nine randomised trials, one nonrandomised pivotal
Three implanted closed-loop neurostimulators that sense a microvolt neural signal and adjust stimulation from it hold US PMA (premarket approval) approval: Saluda Evoke (P190002, 2022), NeuroPace RNS (P100026,
[5][15][12][11]. Randomised trials have compared a sensed, closed-loop arm against a fixed or non-triggered arm in spinal cord stimulation, epilepsy, Parkinson disease, stroke upper-limb rehabilitation and anal incontinence, with positive and null results both on record [1][13][10][16][17][21]. In a 2026 trial in women with stress urinary incontinence, sEMG-triggered intravaginal stimulation was compared with sham stimulation, not with the same stimulation run open-loop [23]. The per-case evidence, most of it single-source or sponsor-funded, is in section 3.
_Baseline (v1). No prior version; this establishes the starting point for future diffs._
Had to show: in a double-blind RCT (randomised controlled trial) at 13 US sites, that ECAP-controlled closed-loop SCS was non-inferior, then superior, to "fixed-output, open-loop spinal cord stimulation" on the proportion of patients with ≥50% back-and-leg pain reduction without increased medication [1][2] [sponsor-reported].
What happened: 134 randomised (Feb 2017–Feb 2018); at 3 months 51/62 (82.3%) closed-loop vs 38/63 (60.3%) open-loop, difference 21.9% (95% CI 6.6–37.3; p=0.0052); at 12 months 49/59 (83.1%) vs 36/59 (61.0%), p=0.0060; "no differences in safety profiles" [1] [sponsor-reported]. In 41 closed-loop patients followed to 36 months the loop kept "the elicited ECAP within 4µV of the target", ECAP dose ≥19.3 µV, and 83% had ≥50% relief [4] [sponsor-reported]. PMA P190002 approved 2022-02-28 [5] [single-source]. A recall scan for firm "Saluda" 2021-10-01 to 2026-09-30 returned no records (see section 5).
Transfers: the signal is tens of microvolts and is evoked by the stimulus itself, and the loop adjusts "the stimulus current at each stimulus pulse" [3][4] [single-source]. It is the one case retrieved with a randomised, double-blind closed-loop vs open-loop comparison of otherwise the same stimulation that met superiority [1] [sponsor-reported].
Does not transfer: the ECAP is recorded on "any 2 nonstimulating electrodes on either lead", not on the stimulating contact [3] [single-source]; electrodes are implanted epidural leads; the signal is an evoked compound action potential, not volitional muscle EMG (electromyography).
Had to show: in a single-blind crossover pivotal trial (NCT04547712 (a ClinicalTrials.gov registration number)), that ≥50% of participants met a performance goal on on-time without troublesome dyskinesia during aDBS compared with continuous DBS [6][8] [sponsor-reported].
What happened: 68 participants in the published analysis (registry lists 85 actually enrolled [8]); the goal was met in 91% (dual-threshold) and 79% (single-threshold) with a post hoc threshold; energy delivered fell 15% under single-threshold aDBS [6] [sponsor-reported]. An LFP control signal (8–30 Hz, "≥1.2 µVp") was identified in 84.8% of patients on medication [7] [sponsor-reported]. Approval announced 2025-02-24 [11] [manufacturer]. A separate 9-patient double-blind crossover RCT (2026) found "No statistically significant differences" between aDBS and cDBS [10] [single-source].
Transfers: the device senses and stimulates at the same time on the same lead; artifact is handled "by shorting the amplifier input briefly during the stimulation artifact, called 'blanking'" and time-locking stimulation to sampling; stated sensing range 0.55–400 µVrms [9] [single-source].
Does not transfer: sensing is bipolar between the contacts surrounding the stimulating contacts, not the stimulating contact itself [9] [single-source]; the pivotal is published as "A Nonrandomized Clinical Trial" whose primary end point was a performance goal against continuous DBS, not a superiority test [6] [sponsor-reported]; the signal is intracranial.
Had to show: in a double-blind RCT, that stimulation delivered in response to detected electrocorticographic activity reduced seizures versus sham (no stimulation) [13] [single-source].
What happened: 191 adults; blinded-period seizure change −37.9% (n=97) vs −17.3% sham (n=94), p=0.012 [13] [single-source]. PMA P100026 approved 2013-11-14 [15] [single-source].
Transfers: each lead's four electrodes "can be assigned to one or two of four amplifier channels" and the same leads deliver the stimulation [14] [manufacturer]; the device fires often — the manual's battery profile assumes 100 / 570 / 1330 bursts per day at the 5th / 50th / 95th percentile [14] [manufacturer].
Does not transfer: stimulation is brief bursts (100 ms in the manual's profile) between detections, so the comparison was responsive stimulation vs no stimulation, not vs open-loop stimulation [13][14]; no detection false-positive rate was retrieved.
Had to show: that stimulation gated or scaled by the paretic muscle's own residual EMG beats cyclic (open-loop) stimulation or usual care [16][17][18].
What happened: 122 subacute stroke survivors randomised to cyclic NMES (neuromuscular electrical stimulation), EMG-triggered NMES or sensory stimulation showed "no significant difference in the improvement among groups" (2016) [16] [single-source]; 22 chronic patients, cyclic vs EMG-triggered, no significant difference in ARAT gain (2008) [17] [single-source]. A multicentre RCT of MeCFES (82 randomised, 68 completed) "did not meet the planned sample size" and reported only a trend in subacute patients [18] [single-source].
Transfers: surface electrodes on skeletal muscle; shared-electrode stimulation and volitional EMG acquisition has been built with "hardware blanking with electrodes shorting" [19] [single-source], and a separate front-end reached a 7.6 ms blanking time with template subtraction, sEMG–torque correlation 0.48 ± 0.11 in 3 stroke participants [20] [single-source].
Does not transfer: limb muscle through skin, not pelvic floor through vaginal mucosa; clinician-supervised sessions, not self-inserted home use.
Had to show: superiority of combined amplitude-modulated medium-frequency stimulation and EMG biofeedback over biofeedback alone, then over low-frequency stimulation [21][22] [single-source].
What happened: vs LFS, 80 patients, 6 months: continence regained by 54% (3T) vs none (LFS), p<0.001 [21]; vs EMG-BF, 158 patients: Cleveland score fell 3 points more with 3T (p=0.0024) [22] [single-source].
Transfers: a pelvic floor muscle, a home-used probe, and an EMG-linked stimulation arm beat stimulation without EMG in an RCT [21] [single-source].
Does not transfer: the arms also differed in stimulation waveform (medium- vs low-frequency), so the EMG link is confounded [21]; whether EMG was sensed on the stimulating electrode during stimulation is not stated in either abstract.
Had to show: that sEMG-triggered intravaginal stimulation added to supervised PFMT (pelvic floor muscle training) improves muscle strength and continence vs PFMT plus placebo stimulation [23] [single-source].
What happened: 42 women with SUI (stress urinary incontinence) and very weak PFMs, 36 at 12 months; +0.59 Oxford points at 12 months (p=0.009), −1.51 leakage episodes/week (p=0.001) (2026) [23] [single-source].
Transfers: same population, same intravaginal interface, EMG-linked stimulation [23].
Does not transfer: comparator was sham, not open-loop stimulation; the abstract does not state whether EMG was recorded during stimulation or only to trigger it [23].
[1] Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial — The Lancet Neurology (published 2020-02, day not given in the PubMed record; accessed 2026-09-30). PMID (PubMed identifier) 31870766 — https://pubmed.ncbi.nlm.nih.gov/31870766/ [peer-reviewed] [2] Safety and Efficacy Study of the Evoke SCS System With Feedback vs. Conventional Stimulation — ClinicalTrials.gov (record last updated 2024-01-03; accessed 2026-09-30). NCT02924129 — https://clinicaltrials.gov/study/NCT02924129 [trial-registry] [3] Russo M et al. Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study — Neurosurgery (published 2020, month not retrieved; accessed 2026-09-30). PMID 32023344; DOI 10.1093/neuros/nyaa003 — https://pmc.ncbi.nlm.nih.gov/articles/PMC8184296/ [peer-reviewed] [4] Neurophysiological outcomes that sustained clinically significant improvements over 3 years of physiologic ECAP-controlled closed-loop spinal cord stimulation for the treatment of chronic pain — Regional Anesthesia and Pain Medicine (published 2025-06-10; accessed 2026-09-30). PMID 38490687 — https://pubmed.ncbi.nlm.nih.gov/38490687/ [peer-reviewed] [5] PMA P190002, Saluda Medical Evoke SCS System — openFDA device/pma (original decision 2022-02-28; accessed 2026-09-30). PMA P190002 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190002 [federal-registry] [6] Long-Term Personalized Adaptive Deep Brain Stimulation in Parkinson Disease: A Nonrandomized Clinical Trial — JAMA Neurology (published 2025-11-01; accessed 2026-09-30). PMID 40982287 — https://pubmed.ncbi.nlm.nih.gov/40982287/ [peer-reviewed] [7] Sensing data and methodology from the Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD (Parkinson disease)) clinical trial — NPJ Parkinson's Disease (published 2024-09-17; accessed 2026-09-30). PMID 39289373 — https://pubmed.ncbi.nlm.nih.gov/39289373/ [peer-reviewed] [8] Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease — ClinicalTrials.gov (record last updated 2025-07-08; accessed 2026-09-30). NCT04547712 — https://clinicaltrials.gov/study/NCT04547712 [trial-registry] [9] Sanger ZT et al. Neural signal data collection and analysis of Percept PC BrainSense recordings for thalamic stimulation in epilepsy — Journal of Neural Engineering (published 2024, month not retrieved; accessed 2026-09-30). PMID 38211344; DOI 10.1088/1741-2552/ad1dc3 — https://pmc.ncbi.nlm.nih.gov/articles/PMC11299490/ [peer-reviewed] [10] Clinical Outcomes with Chronic Adaptive Versus Conventional DBS in Parkinson's Disease: A Pilot Randomized Crossover Trial — Movement Disorders Clinical Practice (published 2026-09-21; accessed 2026-09-30). PMID 42765432 — https://pubmed.ncbi.nlm.nih.gov/42765432/ [peer-reviewed] [11] Medtronic earns U.S. FDA (US Food and Drug Administration) approval for the world's first Adaptive deep brain stimulation system for people with Parkinson's — Medtronic newsroom (published 2025-02-24; accessed 2026-09-30). [no-identifier] a corporate press release carries no registrar number — https://news.medtronic.com/2025-02-24-Medtronic-earns-U-S-FDA-approval-for-the-worlds-first-Adaptive-deep-brain-stimulation-system-for-people-with-Parkinsons [manufacturer] [12] PMA P960009, Medtronic Activa Tremor Control System (the PMA under which a "Percept" trade-name search resolves) — openFDA device/pma (original decision 1997-07-31; latest supplement 2026-08-21; accessed 2026-09-30). PMA P960009 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009 [federal-registry] [13] Responsive cortical stimulation for the treatment of medically intractable partial epilepsy — Neurology (published 2011-09-27; accessed 2026-09-30). PMID 21917777 — https://pubmed.ncbi.nlm.nih.gov/21917777/ [peer-reviewed] [14] RNS System User Manual, Model RNS-300M — NeuroPace, Inc. (Rev Date 2019-01, day not given; accessed 2026-09-30). [no-identifier] manufacturer labelling; its only number is NeuroPace's internal document number DN 1017309 Rev 4, which no registrar issues — https://www.neuropace.com/wp-content/uploads/2021/02/rns-system-manual-300m.pdf [manufacturer] [15] PMA P100026, NeuroPace RNS System — openFDA device/pma (original decision 2013-11-14; accessed 2026-09-30). PMA P100026 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100026 [federal-registry] [16] Upper-Limb Recovery After Stroke: A Randomized Controlled Trial Comparing EMG-Triggered, Cyclic, and Sensory Electrical Stimulation — Neurorehabilitation and Neural Repair (published 2016-11, day not given in the PubMed record; accessed 2026-09-30). PMID 27225977 — https://pubmed.ncbi.nlm.nih.gov/27225977/ [peer-reviewed] [17] Electrical stimulation of the upper extremity in stroke: cyclic versus EMG-triggered stimulation — Clinical Rehabilitation (published 2008-08, day not given in the PubMed record; accessed 2026-09-30). PMID 18678569 — https://pubmed.ncbi.nlm.nih.gov/18678569/ [peer-reviewed] [18] Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach — PLoS One (published 2017, month not given in the PubMed record; accessed 2026-09-30). PMID 29200424 — https://pubmed.ncbi.nlm.nih.gov/29200424/ [peer-reviewed] [19] Design of a Savitzky-Golay Filter-Based vEMG-FES System — IEEE Transactions on Neural Systems and Rehabilitation Engineering (published 2025, month not given in the PubMed record; accessed 2026-09-30). PMID 40031144 — https://pubmed.ncbi.nlm.nih.gov/40031144/ [peer-reviewed] [20] A hybrid method for real-time stimulation artefact removal during functional electrical stimulation with time-variant parameters — Journal of Neural Engineering (published 2021-04-26; accessed 2026-09-30). PMID 33836509 — https://pubmed.ncbi.nlm.nih.gov/33836509/ [peer-reviewed] [21] Triple-target treatment versus low-frequency electrostimulation for anal incontinence: a randomized, controlled trial — Deutsches Ärzteblatt International (published 2011-09, day not given in the PubMed record; accessed 2026-09-30). PMID 22013492; DRKS00000138 — https://pubmed.ncbi.nlm.nih.gov/22013492/ [peer-reviewed] [22] Triple target treatment (3T) is more effective than biofeedback alone for anal incontinence: the 3T-AI study — Diseases of the Colon and Rectum (published 2010-07, day not given in the PubMed record; accessed 2026-09-30). PMID 20551752; NCT00525291 — https://pubmed.ncbi.nlm.nih.gov/20551752/ [peer-reviewed] [23] Pelvic muscle training and electrostimulation to treat weak pelvic floor: a multicentre-randomised parallel group trial — European Journal of Obstetrics, Gynecology, and Reproductive Biology (published 2026-07, day not given in the PubMed record; accessed 2026-09-30). PMID 42190320 — https://pubmed.ncbi.nlm.nih.gov/42190320/ [peer-reviewed] [24] Device-level comparisons of sensing and stimulation in implantable closed-loop neurostimulation for epilepsy — Neurotherapeutics (published 2026-07, day not given in the PubMed record; accessed 2026-09-30). PMID 42641499 — https://pubmed.ncbi.nlm.nih.gov/42641499/ [peer-reviewed]
Well established: only the section 1 lines — three US PMA records for sensing closed-loop stimulators [5][12][15] with the Percept adaptive feature dated by the manufacturer [11], and the existence of randomised sensed-vs-unsensed comparisons across five conditions [1][10][13][16][17][21].
Thin: every quantity in section 3 rests on one abstract. EVOKE [1][2][4] and ADAPT-PD [6][7][8] are sponsor-funded or sponsor-registered and marked [sponsor-reported]; the RNS manual [14] and the aDBS announcement [11] are [manufacturer]. Which contact senses — Evoke [3], Percept [9] — is each single-source. Everything was read at abstract or open-access full-text depth; no appraisal of methods or risk of bias was done.
Rescoped from class 3: none in this report. The row asks what sponsors had to show and what happened, which is class 2 throughout.
Out of scope: the Evoke, RNS and Percept aDBS approval orders and SSEDs on fda.gov (bot mitigation; approval dates come from openFDA instead, and the Percept aDBS supplement number was not identified — the trade-name search resolved only to P960009); CE-marked or non-US systems named in a 2026 device-level review [24], such as Newronika AlphaDBS and PINS G106RS, which no connector here can reach; MAUDE (Manufacturer and User Facility Device Experience); patents.
Not searched vs. not found: Not found — a sensing false-trigger or false-detection rate for any case, and amplifier recovery time for any implanted case; a randomised comparison of the same intravaginal stimulation run EMG-gated versus open-loop in SUI (literature searches "EMG-triggered electrical stimulation incontinence" and "closed-loop pelvic floor stimulation" returned none or off-topic records). Not searched — published amplitude of vaginal-surface pelvic floor EMG relative to stimulation artifact, so no signal-to-artifact ratio for the pillar's interface is reported here; RNS detection-architecture details (the manual text was extracted from a PDF and no blanking statement was located in it). A recall scan (recalls --firm) returned no records for Saluda (2021-10-01 to 2026-09-30) or NeuroPace (2016-10-02 to 2026-09-30); a scan is a pointer, not a finding, and is not cited as a source.
[inference] In every implanted case retrieved, the recording contact is a different contact from the one delivering current (Evoke, Percept) or recording is interleaved with brief bursts (RNS); only the surface FES engineering papers [19][20] describe acquisition through the stimulating electrodes themselves, and neither reports a clinical closed-vs-open-loop outcome. [inference] The two closed-vs-open comparisons nearest the pillar in anatomy — 3T [21] and stroke EMG-triggered NMES [16][17] — split: 3T positive but confounded by waveform, stroke null.
| Proposition | Evidence class | Resolvable identifier | Dossier section |
|---|---|---|---|
| In a 134-patient double-blind RCT, ECAP-controlled closed-loop SCS achieved ≥50% pain reduction in 82.3% vs 60.3% for open-loop at 3 months (p=0.0052) | 2 published | PMID 31870766 | reference-products |
| The Evoke system records the ECAP on two non-stimulating electrodes, not on the stimulating contact | 2 published | PMID 32023344 | technology |
| Percept PC BrainSense suppresses stimulation artifact by blanking (shorting the amplifier input) and senses bipolar between contacts surrounding the stimulating contacts | 2 published | PMID 38211344 | technology |
| In ADAPT-PD, an LFP control signal (8–30 Hz, ≥1.2 µVp) was identified in 84.8% of patients on medication | 2 published | PMID 39289373 | technology |
| A 9-patient double-blind crossover RCT found no statistically significant difference between beta-LFP aDBS and conventional DBS | 2 published | PMID 42765432 | clinical-evidence |
| In a 122-patient RCT in subacute stroke, EMG-triggered NMES did not differ from cyclic NMES on Fugl-Meyer or mAMAT | 2 published | PMID 27225977 | clinical-evidence |
| In an 80-patient RCT in anal incontinence, 54% regained continence with 3T vs none with low-frequency stimulation at 6 months | 2 published | PMID 22013492 | clinical-evidence |
| In 42 women with SUI and very weak PFMs, sEMG-triggered intravaginal stimulation plus PFMT outperformed PFMT plus sham on 12-month leakage episodes | 2 published | PMID 42190320 | clinical-evidence |
| The NeuroPace RNS System holds PMA P100026, approved 2013-11-14 | 1 registry | PMA P100026 | reference-products |
| The Saluda Evoke SCS System holds PMA P190002, approved 2022-02-28 | 1 registry | PMA P190002 | reference-products |
_shared/plain-language.md