{ "id": "AIBD-0366", "title": "Xuanwu Hospital implants China's first closed-loop responsive neurostimulator, Epilcure, with an on-skull AI chip in a man with drug-resistant bilateral temporal lobe epilepsy (9 Mar 2022)", "summary": "9 Mar 2022: Xuanwu Hospital, Beijing, implanted Epilcure, a closed-loop neurostimulator whose on-skull AI chip monitors EEG and stimulates on predicted seizures, in a man with drug-resistant epilepsy.", "date_observed": "2022-03-09", "date_basis": "unassessed", "date_precision": "unassessed", "benefit_status": null, "source_collection": null, "source_entry": null, "account": "On 9 March 2022 a team at Xuanwu Hospital, Capital Medical University, Beijing, implanted the Epilcure closed-loop responsive neurostimulation system. Hospital president Zhao Guoguang and neurosurgeon Shan Yongzhi led it. The patient, a man with drug-resistant bilateral temporal lobe epilepsy, was the first enrollee in a hospital-led NMPA registration clinical trial. Sources: cnBeta and Kuai Keji (12 March 2022), both citing the neurosurgery department's WeChat account. The reports describe an AI chip implanted in the skull, with intracranial electrodes monitoring electroencephalography (EEG) rhythms around the clock. On predicting an imminent seizure, it delivers an interfering rhythm to block seizure formation at the focus. Bilateral temporal lobe epilepsy is called a relative contraindication for open surgery. The operation went smoothly and the stimulator's indicators worked normally during surgery. Post-operative reconstruction showed precise electrode placement and clear EEG signals (cnBeta). No seizure outcome, patient age or follow-up is reported; the device's maker is not named.", "category": "benefit created", "unexpected": false, "purpose": "Epilcure was built to detect the onset of seizures from continuously monitored intracranial EEG and deliver stimulation to abort them in people with drug-resistant epilepsy. Implanting it for that purpose was the intended use, though no seizure outcome is yet reported.", "system": "Epilcure closed-loop responsive neurostimulation system (brain-computer interface)", "model_version": null, "developer": null, "deployer": "Xuanwu Hospital, Capital Medical University, Beijing", "location": "Beijing, China", "domain": "Healthcare (epilepsy; responsive neurostimulation)", "segment": "Implanted neuromodulation device in a registration clinical trial", "benefit_type": "Improved Physical Health", "taxonomy_note": "The documented outcome is a successful implantation with the device working, not seizure reduction.", "registry_ids": { "oecd_aim": "2022-03-11-af88" }, "ratings": [ { "group": "personal", "depth": null, "reason": "The reports establish a successful implantation with the stimulator working normally and electrodes precisely placed. No reduction in seizures, follow-up or patient-reported outcome is given, so the benefit to the patient's health is not yet established." } ], "ai_role": { "status": "unassessed", "statement": "The hospital, as relayed by the reports, describes the AI element as an on-skull chip. It monitors intracranial EEG continuously and predicts imminent seizures to trigger interfering stimulation. The read reports establish only that the implant functioned during surgery and that electrodes were placed precisely. No detection or stimulation event, seizure count or follow-up is reported. What the AI contributed to the patient cannot be assessed from these sources." }, "evidence": [ { "kind": "news report", "citation": "cnBeta (2022). 中国首例“脑机接口”反应性闭环神经刺激系统植入成功. cnBeta.COM, 12 March 2022.", "title": "中国首例“脑机接口”反应性闭环神经刺激系统植入成功", "url": "https://www.cnbeta.com.tw/articles/tech/1246089.htm", "date": "2022-03-12", "written_by": "independent", "quote": "术中刺激器各项指标均工作正常，术后重建显示电极位置精准" }, { "kind": "news report", "citation": "Jian J (2022). 中国首例“脑机接口”反应性闭环神经刺激系统植入成功：人工智能芯片直连大脑. 快科技 (MyDrivers), 12 March 2022.", "title": "中国首例“脑机接口”反应性闭环神经刺激系统植入成功：人工智能芯片直连大脑", "url": "https://news.mydrivers.com/1/819/819786.htm", "date": "2022-03-12", "written_by": "independent", "quote": "通过将人工智能芯片植入颅骨，颅内电极植入脑内" }, { "kind": "news report", "citation": "Phoenix Technology (2022). 中国首例“脑机接口”反应性闭环神经刺激系统植入成功：AI芯片直连大脑. 凤凰网科技, 12 March 2022.", "title": "中国首例“脑机接口”反应性闭环神经刺激系统植入成功：AI芯片直连大脑", "url": "https://tech.ifeng.com/c/8EJq2tqI1TE", "date": "2022-03-12", "written_by": "independent", "quote": "一旦预测到即将发生的癫痫，即启动外源性干扰节律" }, { "kind": "registry label", "citation": "OECD.AI (2022). China's First AI-Powered Brain-Computer Interface Implanted to Prevent Epileptic Seizures. OECD AI Incidents and Hazards Monitor, entry 2022-03-11-af88.", "title": "China's First AI-Powered Brain-Computer Interface Implanted to Prevent Epileptic Seizures", "url": "https://oecd.ai/en/incidents/2022-03-11-af88", "date": null, "written_by": "independent", "quote": "The AI chip continuously monitors brain activity and intervenes to prevent seizures, marking a significant clinical application of AI in healthcare with direct positive impact on patient health." } ], "replication": { "produced_by": [ "Intracranial electrodes at the epileptic focus feeding continuous EEG to a chip implanted in the skull", "A seizure-prediction routine on the chip that triggers an interfering stimulation rhythm when it predicts an imminent seizure", "Enrollment in the hospital-led NMPA registration trial for patients whose epilepsy is drug-resistant and unsuited to open surgery" ], "must_hold": [ "Electrode placement is precise and signals are clear, as the post-operative reconstruction reported here", "The prediction fires early enough and specifically enough to abort seizures, which no cited source yet documents" ], "echoes": [] }, "paired_incident": null, "headline": "Xuanwu Hospital implants China's first responsive neurostimulator", "metric": null, "comparator": null, "later": null, "value": null, "developer_country": null, "deployer_country": "China", "unrated_because": null, "brief_notes": null, "brief": null, "revisions": [ { "date": "2026-10-21", "change": "Record drafted from the OECD Monitor entry and the cited sources.", "source": "https://oecd.ai/en/incidents/2022-03-11-af88", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Accessibility among the six first used.", "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Country of the deployer added from the organization's own site or a registry.", "source": "https://en.wikipedia.org/wiki/Xuanwu_Hospital", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: a rating reason, account, purpose, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.", "source": null, "editor": "AIBD" } ], "confidence": "reported", "shade": "medium", "claim_status": "Independently reported", "claim_basis": "Sources: three independent news reports and a registry entry. The cited evidence includes no independent study or report and no finding by a regulator or court.", "profile": { "case_id": "AIBD-0366", "catalog_version": "1.0.0", "source_fingerprint": "8763a5d15e0002a555a5ed84b4f2f4b3510344b175cf687169aa839ec3157f27", "collection_refs": [ { "collection_id": "aibd", "version": "snapshot-8bf7cfec9cb185aa" }, { "collection_id": "aibd", "version": "2026-10-25" } ], "source_ids": [ "AIBD-0366-source-0001", "AIBD-0366-source-0002", "AIBD-0366-source-0003", "AIBD-0366-source-0004" ], "families": { "strategic assessments": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "evaluations": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "monetary observations": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "institutional decisions": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] } }, "fields": { "actors[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "deployer": "Xuanwu Hospital, Capital Medical University, Beijing" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "deployer" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "actors[].ownership_control": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "ai_contribution": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "ai_relationship": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "category": "benefit created", "ai_role": { "status": "unassessed", "statement": "The hospital, as relayed by the reports, describes the AI element as an on-skull chip. It monitors intracranial EEG continuously and predicts imminent seizures to trigger interfering stimulation. The read reports establish only that the implant functioned during surgery and that electrodes were placed precisely. No detection or stimulation event, seizure count or follow-up is reported. What the AI contributed to the patient cannot be assessed from these sources." } } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "ai_role", "category" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "assessments[].alternatives": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "assessments[].assessor_date": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "assessments[].depth": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "assessments[].display_confidence": { "state": "value_present", "value": { "kind": "structured", "data": { "confidence": "medium", "evidence_word": "reported", "claim_status": "Independently reported", "basis": "Sources: three independent news reports and a registry entry. 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Hospital president Zhao Guoguang and neurosurgeon Shan Yongzhi led it. The patient, a man with drug-resistant bilateral temporal lobe epilepsy, was the first enrollee in a hospital-led NMPA registration clinical trial. Sources: cnBeta and Kuai Keji (12 March 2022), both citing the neurosurgery department's WeChat account. The reports describe an AI chip implanted in the skull, with intracranial electrodes monitoring electroencephalography (EEG) rhythms around the clock. On predicting an imminent seizure, it delivers an interfering rhythm to block seizure formation at the focus. Bilateral temporal lobe epilepsy is called a relative contraindication for open surgery. The operation went smoothly and the stimulator's indicators worked normally during surgery. Post-operative reconstruction showed precise electrode placement and clear EEG signals (cnBeta). No seizure outcome, patient age or follow-up is reported; the device's maker is not named.", "benefit_type": "Improved Physical Health" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "account", "benefit_type" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "outcomes[].distribution": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].duration": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].id": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].stakeholder_group": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "ratings": [ { "group": "personal", "reason": "The reports establish a successful implantation with the stimulator working normally and electrodes precisely placed. No reduction in seizures, follow-up or patient-reported outcome is given, so the benefit to the patient's health is not yet established." } ] } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "ratings" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "outcomes[].status": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].tradeoffs": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].unexpected": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "unexpected": false, "purpose": "Epilcure was built to detect the onset of seizures from continuously monitored intracranial EEG and deliver stimulation to abort them in people with drug-resistant epilepsy. Implanting it for that purpose was the intended use, though no seizure outcome is yet reported." } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "unexpected", "purpose" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "places[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "location": "Beijing, China", "deployer_country": "China" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "location", "deployer_country" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "purpose": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "purpose": "Epilcure was built to detect the onset of seizures from continuously monitored intracranial EEG and deliver stimulation to abort them in people with drug-resistant epilepsy. Implanting it for that purpose was the intended use, though no seizure outcome is yet reported." } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "purpose" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "record_dates": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "date_observed": "2022-03-09", "revisions": [ { "date": "2026-10-21", "change": "Record drafted from the OECD Monitor entry and the cited sources.", "source": "https://oecd.ai/en/incidents/2022-03-11-af88", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Accessibility among the six first used.", "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Country of the deployer added from the organization's own site or a registry.", "source": "https://en.wikipedia.org/wiki/Xuanwu_Hospital", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: a rating reason, account, purpose, the system's part rewritten in shorter sentences with abbreviations expanded; 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facts, figures and quotations unchanged.", "editor": "AIBD" } ] } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "revisions" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "sector": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "domain": "Healthcare (epilepsy; responsive neurostimulation)", "segment": "Implanted neuromodulation device in a registration clinical trial" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "domain", "segment" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "sources[].access_version": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "sources[].citation_locator": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "evidence": [ { "kind": "news report", "citation": "cnBeta (2022). 中国首例“脑机接口”反应性闭环神经刺激系统植入成功. cnBeta.COM, 12 March 2022.", "title": "中国首例“脑机接口”反应性闭环神经刺激系统植入成功", "url": "https://www.cnbeta.com.tw/articles/tech/1246089.htm", "date": "2022-03-12", "written_by": "independent", "quote": "术中刺激器各项指标均工作正常，术后重建显示电极位置精准" }, { "kind": "news report", "citation": "Jian J (2022). 中国首例“脑机接口”反应性闭环神经刺激系统植入成功：人工智能芯片直连大脑. 快科技 (MyDrivers), 12 March 2022.", "title": "中国首例“脑机接口”反应性闭环神经刺激系统植入成功：人工智能芯片直连大脑", "url": "https://news.mydrivers.com/1/819/819786.htm", "date": "2022-03-12", "written_by": "independent", "quote": "通过将人工智能芯片植入颅骨，颅内电极植入脑内" }, { "kind": "news report", "citation": "Phoenix Technology (2022). 中国首例“脑机接口”反应性闭环神经刺激系统植入成功：AI芯片直连大脑. 凤凰网科技, 12 March 2022.", "title": "中国首例“脑机接口”反应性闭环神经刺激系统植入成功：AI芯片直连大脑", "url": "https://tech.ifeng.com/c/8EJq2tqI1TE", "date": "2022-03-12", "written_by": "independent", "quote": "一旦预测到即将发生的癫痫，即启动外源性干扰节律" }, { "kind": "registry label", "citation": "OECD.AI (2022). China's First AI-Powered Brain-Computer Interface Implanted to Prevent Epileptic Seizures. 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China's First AI-Powered Brain-Computer Interface Implanted to Prevent Epileptic Seizures. 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No seizure outcome, patient age or follow-up is reported; the device's maker is not named." } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "summary", "account" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "systems[].autonomy_permissions": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].component_role": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].deployment_configuration": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].inputs_outputs": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].model_name": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].model_version": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].product_name": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "system": "Epilcure closed-loop responsive neurostimulation system (brain-computer interface)" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "system" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "systems[].provider": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "taxonomy_crosswalks[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "title": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "title": "Xuanwu Hospital implants China's first closed-loop responsive neurostimulator, Epilcure, with an on-skull AI chip in a man with drug-resistant bilateral temporal lobe epilepsy (9 Mar 2022)", "headline": "Xuanwu Hospital implants China's first responsive neurostimulator" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "title", "headline" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "version": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "8763a5d15e0002a555a5ed84b4f2f4b3510344b175cf687169aa839ec3157f27" ], "role": "SHA-256 of normalized original case data" }, "provenance": { "kind": "curatorial", "basis": "Deterministic content version assigned by the local migration.", "record_fields": [], "source_refs": [] }, "review_state": "record_mapped", "coverage": "complete" }, "workflow": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "account": "On 9 March 2022 a team at Xuanwu Hospital, Capital Medical University, Beijing, implanted the Epilcure closed-loop responsive neurostimulation system. Hospital president Zhao Guoguang and neurosurgeon Shan Yongzhi led it. The patient, a man with drug-resistant bilateral temporal lobe epilepsy, was the first enrollee in a hospital-led NMPA registration clinical trial. Sources: cnBeta and Kuai Keji (12 March 2022), both citing the neurosurgery department's WeChat account. The reports describe an AI chip implanted in the skull, with intracranial electrodes monitoring electroencephalography (EEG) rhythms around the clock. On predicting an imminent seizure, it delivers an interfering rhythm to block seizure formation at the focus. Bilateral temporal lobe epilepsy is called a relative contraindication for open surgery. The operation went smoothly and the stimulator's indicators worked normally during surgery. Post-operative reconstruction showed precise electrode placement and clear EEG signals (cnBeta). No seizure outcome, patient age or follow-up is reported; the device's maker is not named.", "replication": { "produced_by": [ "Intracranial electrodes at the epileptic focus feeding continuous EEG to a chip implanted in the skull", "A seizure-prediction routine on the chip that triggers an interfering stimulation rhythm when it predicts an imminent seizure", "Enrollment in the hospital-led NMPA registration trial for patients whose epilepsy is drug-resistant and unsuited to open surgery" ], "must_hold": [ "Electrode placement is precise and signals are clear, as the post-operative reconstruction reported here", "The prediction fires early enough and specifically enough to abort seizures, which no cited source yet documents" ], "echoes": [] } } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "account", "replication" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" } }, "summary": { "total": 91, "addressed": 91, "known": 25, "reviewed": 0, "record_mapped": 25, "not_assessed": 66, "complete": false, "by_state": { "value_present": 25, "not_reported": 0, "unresolved": 0, "not_assessed": 66, "not_applicable": 0, "withheld": 0, "source_unavailable": 0 } } } }