PMID- 35234664 OWN - NLM STAT- MEDLINE DCOM- 20220401 LR - 20230429 IS - 1741-2552 (Electronic) IS - 1741-2560 (Print) IS - 1741-2552 (Linking) VI - 19 IP - 2 DP - 2022 Mar 31 TI - Concurrent stimulation and sensing in bi-directional brain interfaces: a multi-site translational experience. LID - 10.1088/1741-2552/ac59a3 [doi] AB - Objective. To provide a design analysis and guidance framework for the implementation of concurrent stimulation and sensing during adaptive deep brain stimulation (aDBS) with particular emphasis on artifact mitigations.Approach. We defined a general architecture of feedback-enabled devices, identified key components in the signal chain which might result in unwanted artifacts and proposed methods that might ultimately enable improved aDBS therapies. We gathered data from research subjects chronically-implanted with an investigational aDBS system, Summit RC + S, to characterize and explore artifact mitigations arising from concurrent stimulation and sensing. We then used a prototype investigational implantable device, DyNeuMo, and a bench-setup that accounts for tissue-electrode properties, to confirm our observations and verify mitigations. The strategies to reduce transient stimulation artifacts and improve performance during aDBS were confirmed in a chronic implant using updated configuration settings.Main results.We derived and validated a 'checklist' of configuration settings to improve system performance and areas for future device improvement. Key considerations for the configuration include (a) active instead of passive recharge, (b) sense-channel blanking in the amplifier, (c) high-pass filter settings, (d) tissue-electrode impedance mismatch management, (e) time-frequency trade-offs in the classifier, (f) algorithm blanking and transition rate limits. Without proper channel configuration, the aDBS algorithm was susceptible to limit-cycles of oscillating stimulation independent of physiological state. By applying the checklist, we could optimize each block's performance characteristics within the overall system. With system-level optimization, a 'fast' aDBS prototype algorithm was demonstrated to be feasible without reentrant loops, and with noise performance suitable for subcortical brain circuits.Significance. We present a framework to study sources and propose mitigations of artifacts in devices that provide chronic aDBS. This work highlights the trade-offs in performance as novel sensing devices translate to the clinic. Finding the appropriate balance of constraints is imperative for successful translation of aDBS therapies.Clinical trial:Institutional Review Board and Investigational Device Exemption numbers: NCT02649166/IRB201501021 (University of Florida), NCT04043403/IRB52548 (Stanford University), NCT03582891/IRB1824454 (University of California San Francisco). IDE #180 097. CI - Creative Commons Attribution license. FAU - Anso, Juan AU - Anso J AUID- ORCID: 0000-0001-9127-0396 AD - Department of Neurological Surgery, University of California, San Francisco, CA, United States of America. FAU - Benjaber, Moaad AU - Benjaber M AUID- ORCID: 0000-0002-0506-2337 AD - MRC Brain Network Dynamics Unit, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom. FAU - Parks, Brandon AU - Parks B AUID- ORCID: 0000-0002-1317-5358 AD - Department of Electrical and Computer Engineering, University of Florida, Gainesville, FL, United States of America. FAU - Parker, Samuel AU - Parker S AD - School of Engineering and Carney Institute, Brown University, Providence, RI, United States of America. FAU - Oehrn, Carina Renate AU - Oehrn CR AD - Department of Neurological Surgery, University of California, San Francisco, CA, United States of America. FAU - Petrucci, Matthew AU - Petrucci M AD - Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Stanford, CA, United States of America. FAU - Gilron, Ro'ee AU - Gilron R AUID- ORCID: 0000-0001-8761-5654 AD - Department of Neurological Surgery, University of California, San Francisco, CA, United States of America. FAU - Little, Simon AU - Little S AD - Department of Neurology, University of California San Francisco, San Francisco, CA, United States of America. FAU - Wilt, Robert AU - Wilt R AD - Department of Neurological Surgery, University of California, San Francisco, CA, United States of America. FAU - Bronte-Stewart, Helen AU - Bronte-Stewart H AD - Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Stanford, CA, United States of America. FAU - Gunduz, Aysegul AU - Gunduz A AD - Department of Biomedical Engineering, University of Florida, Gainesville, FL, United States of America. FAU - Borton, David AU - Borton D AUID- ORCID: 0000-0003-0710-3005 AD - School of Engineering and Carney Institute, Brown University, Providence, RI, United States of America. FAU - Starr, Philip A AU - Starr PA AD - Department of Neurological Surgery, University of California, San Francisco, CA, United States of America. FAU - Denison, Timothy AU - Denison T AD - Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom. LA - eng GR - R01 NS096008/NS/NINDS NIH HHS/United States GR - T32 HD043730/HD/NICHD NIH HHS/United States GR - U24 NS113637/NS/NINDS NIH HHS/United States GR - K23 NS120037/NS/NINDS NIH HHS/United States GR - S10 OD025181/OD/NIH HHS/United States GR - UH3 NS100544/NS/NINDS NIH HHS/United States GR - UH3 NS107709/NS/NINDS NIH HHS/United States GR - UH3 NS095553/NS/NINDS NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20220331 PL - England TA - J Neural Eng JT - Journal of neural engineering JID - 101217933 SB - IM MH - Algorithms MH - Brain MH - *Deep Brain Stimulation/methods MH - Feedback MH - Humans PMC - PMC9095704 MID - NIHMS1794307 OTO - NOTNLM OT - adaptive deep brain stimulation OT - algorithms OT - artifacts OT - chronic implant OT - closed loop OT - embedded OT - neural sensing COIS- Conflict of interest JA and RG have worked for Rune Labs Inc. since September 2021. SL is a scientific advisor to Rune Labs Inc. and has received reimbursement for educational activities for Medtronic. Bronte-Stewart serves on a clinical advisory board for Medtronic PLC. TD has received funding for educational activities by Medtronic PLC, has stock ownership in Bioinduction Ltd and Amber Therapeutics, has consulted with Synchron, Cortec Neuro, and Amber Therapeutics. EDAT- 2022/03/03 06:00 MHDA- 2022/04/02 06:00 PMCR- 2023/03/31 CRDT- 2022/03/02 12:18 PHST- 2021/11/30 00:00 [received] PHST- 2022/03/01 00:00 [accepted] PHST- 2022/03/03 06:00 [pubmed] PHST- 2022/04/02 06:00 [medline] PHST- 2022/03/02 12:18 [entrez] PHST- 2023/03/31 00:00 [pmc-release] AID - 10.1088/1741-2552/ac59a3 [doi] PST - epublish SO - J Neural Eng. 2022 Mar 31;19(2):10.1088/1741-2552/ac59a3. doi: 10.1088/1741-2552/ac59a3.