Design Considerations and Clinical Applications of Closed-Loop Neural Disorder Control SoCs

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22nd Asia and South Pacific Design Automation Conference (ASP-DAC 2017) Special Session 4S: Invited Talk Design Considerations and Clinical Applications of Closed-Loop Neural Disorder Control SoCs Chung-Yu (Peter) Wu Biomedical Electronics Translational Research Center Department of Electronics Engineering National Chiao Tung University, Taiwan 1

Outline I. Introduction: Parkinson s Disease and epilepsy II. System Architecture and Design Considerations III. Experimental Results IV. Future Development 2 2

Outline I. Introduction II. System Architecture and Design Consideration III. Experimental Results IV. Future Development 3 3

I. Introduction Parkinson s Disease and Epilepsy Parkinson s disease and epilepsy are common neurological disorders. PD: 1%~2% of the people older than 65. Epilepsy: 70 million people worldwide. Parkinson's disease is caused by the death of dopamine-generating cells in the substantia nigra (SN). The movementrelated symptoms include shaking, rigidity, slowness of movement, and difficulty with walking and gait. 4 4

I. Introduction Parkinson s Disease and Epilepsy Epileptic seizures are caused by sudden excessive electrical discharges in a group of cortical neurons. Seizure Onset Courtesy of Prof. Dr. Yue-Loong Hsin 5 5

I. Introduction Open-Loop VS Closed-Loop Neuromodulation Open-loop DBS neuromodulation system leads to higher power dissipation, frequent battery replacement, and overstimulation symptoms. The closed-loop DBS system composed of neural signal acquisition, bio-signal processor, and biphasic stimulator. Extension 6 6

I. Introduction Open-Loop VS Closed-Loop Neuromodulation The closed-loop epileptic seizure control system 7 7

Outline I. Introduction II. System Architecture and Design Considerations III. Experimental Results IV. Future Development 8 8

II. System Architecture and Design Considerations A. Closed-loop PD DBS system for pre-implant Evaluation 9 9

II. System Architecture and Design Considerations A. Closed-loop PD DBS system for pre-implant Evaluation The Local Field Potential (LFP) is sensed and digitized by the bio-signal acquisition unit using TI ADS1299. The digitized LFP data are then processed by a processor in the NI platform to calculate the β-band power. Once the β-band power exceeds the preset threshold, the stimulator using NI 9269 generates the patient-specific 0.1-3V biphasic voltage stimulations. The closed-loop DBS system meets the IEC 60601-1 for medical electrical equipment. 10 10

II. System Architecture and Design Considerations A. Closed-loop PD DBS system for pre-implant Evaluation The β-band power of LFP is an efficient bio-maker for closed-loop PD DBS system. The extraction of β-band power spectral density is implemented by a decimation-in-frequency FFT algorithm in the NI platform. LFP from Data Acquisition Unit Take 1sec LFP (Sampling Frequency 1000Hz) FFT Extract Beta Band Power 11 11

II. System Architecture and Design Considerations A. Closed-loop PD DBS system for pre-implant Evaluation Specifications of the Stimulator NI 9269: 5~130Hz programmable stimulation frequency 0~3v programmable stimulation voltage Stimulation latency <0.5sec Patient Protection and Isolation Circuit DBS Electrode Reference Electrode 12 12

II. System Architecture and Design Considerations B. Closed-loop implantable SoC for seizure control on Rate [4] W. Chen, et al., A fully-integrated 8-channel closed-loop neural-prosthetic CMOS SoC for real-time epileptic seizure control, IEEE J. Solid-State Circuits, vol. 49, no. 1, pp. 232-247, Jan. 2014. 13 13

II. System Architecture and Design Considerations B. Closed-loop implantable SoC for seizure control on Rate The ieeg (ECoG) is sensed by a low-noise, low-power, and programmable gain pre-amp and digitized by a delta-modulated SAR ADC. The digitized ieeg are then processed by a specific algorithm for seizure detection in the bio-signal processor. Once the seizure is detected, the stimulator generates a fixed 30μA biphasic stimulation current to suppress the seizure onset. The wireless power and the MedRadio-band transceiver for bilateral data telemetry are implemented to extend device lifetime, to provide essential information for medical doctors., and to enable the control of implanted device from outside. 14 14

II. System Architecture and Design Considerations B. Closed-loop implantable SoC for seizure control on Rate Feature Extraction of Seizure Detection: 15 15

II. System Architecture and Design Considerations B. Closed-loop implantable SoC for seizure control on Rate Features of Brain Waves: 16 16

Outline I. Introduction II. System Architecture and Design Considerations III. Experimental Results IV. Future Development 17 17

III. Experimental Results A. Closed-loop PD DBS system for pre-implant Evaluation Measurement setup GUI Stimulation waveform Closed-loop PD DBS system NI 9269 simulator 18 18

III. Experimental Results A. Closed-loop PD DBS system for pre-implant Evaluation Recorded LFP waveform and power spectral density Recorded LFP waveform LFP power spectral density β-band power 19 19

III. Experimental Results A. Closed-loop PD DBS system for pre-implant Evaluation β-band power spectral density and stimulation control panel Beta band power Stimulation threshold Threshold control Stimulation control Stimulation control 20 20

III. Experimental Results A. Closed-loop PD DBS system for pre-implant Evaluation The biphasic constant-voltage stimulation waveforms 3V 130Hz 120μS 21 21

III. Experimental Results A. Closed-loop PD DBS system for pre-implant Evaluation Stimulator changing voltage 22 22

III. Experimental Results A. Closed-loop PD DBS system for pre-implant Evaluation System demonstration Closed-loop DBS 23 23

III. Experimental Results A. Closed-loop PD DBS system for pre-implant Evaluation Performance summary Parameters Experimental results LFP signal acquisition unit Input common range Input referred noise CMRR 5V 1μVpp 110dB ENOB 21.48 Biphasic constant voltage stimulator Stimulation pulse width Stimulation frequency Stimulation voltage 60μs 15-130Hz 0.1-3V 24 24

III. Experimental Results B. Closed-loop implantable SoC for seizure control on Rate Animal Experiment : 25 25

III Experimental Results B. Closed-loop implantable SoC for seizure control on Rate Acquisition, Detection & Stimulation: 26 26

III. Experimental Results B. Closed-loop implantable SoC for seizure control on Rate Animal Experimental Results : 27 27

III. Experimental Results B. Closed-loop implantable SoC for seizure control on Rate Performance summary Parameters Experimental Results Signal acquisition unit Input-referred noise 5.23μVrms NEF 1.77 Bio-signal processor Accuracy 92% Latency 0.8s Stimulator Stimulation current 30μA Wireless telemetry Rectifier power conversion efficiency Data rate 84% 4M bps Total power consumption 2.8mW (stanby) 28 28

Outline I. Introduction II. System Architecture and Design Considerations III. Experimental Results IV. Future Development 29 29

IV. Future Development A. Closed-loop PD DBS system From the prototype of closed-loop PD DBS system for pre-implant evaluation to SOC The pre-implant evaluation system will be used in clinical trial. The measured data will be used to design the SOC for both preimplant evaluation system and implantable system. SoC is more power efficient with smaller area and it is suitable for implantable system. The wireless power transmission is important to avoid frequent battery replacement. The wireless power will be used to operate the SOC and charge the implantable rechargeable Li battery. The wireless data telemetry is used to transmit LFP out and send commands in for medical doctors. 30 30

IV. Future Developemnt A. Closed-loop PD DBS system System architecture of next generation closed-loop PD DBS SOC 31 31

IV. Future Development B. Closed-loop implantable SoC for seizure control From animal test to clinical trial Up to 3mA stimulation current on cortical surface is required to control human epileptic seizures. Channel number will also be increased to 16 to cover the human brain seizure onset sites. To reduce device area, only one pair of coil is developed for wireless power and bilateral data telemetry and rechargeable battery should be integrated in the implantable device. The designed closed-loop SOC for epileptic seizure control will be used in pre-implant brain evaluation/mapping system and implantable system. 32 32

III. Future Development B. Closed-loop implantable SoC for seizure control From animal test to clinical trial Implantable Electrodes Implantable Wires Implantable Pulse Generator(IPG) 33 33

Thanks for your attention! 34 34