AUDITED REPORT / FULL TEXT
Controlled report text
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Executive summary
As of 23 July 2026, no single non-invasive BCI is the performance, general-purpose, and value winner for every task. The evidence supports three separate decisions: task-specific frontiers, a risk-adjusted research platform, and an auditable low-cost prototype route. Metrics from different paradigms are not pooled into one leaderboard.
Task-specific non-invasive frontier
Recent scalp-EEG studies separately demonstrate online individual-finger class control, continuous two-dimensional pursuit, and low-density dry-electrode code-VEP selection (S0191, S0197, S0192). These are different tasks with different metrics. Selected healthy responders, same-day fine-tuning, accumulated session data, and visual-stimulus constraints prevent extrapolation to unsupervised patient home use or universal cross-day stability.
Best overall implementation
The recommended general research platform remains 32–64-channel professional EEG with hardware event verification, immutable raw data, BIDS, quality gates, classical baselines, compact neural models, confidence rejection, and a deterministic safety state machine. This is a broad platform recommendation, not a claim that more channels win every task.
Best audited value
An OpenBCI-class 8–16-channel wet-electrode system remains the auditable value route for bounded P300, SSVEP, motor-imagery, ERP teaching, and interaction prototypes. A four-channel study supports task feasibility, but does not publish price, supply, interface openness, China delivery, or total cost of ownership (S0199). Lower channel count alone therefore does not establish lower TCO or better value.
Clinical and regulatory balance
Stroke rehabilitation evidence is mixed and must be presented together. A 2025 meta-analysis reported a 3.69-point FMA-UE mean difference with substantial heterogeneity; a 17-centre Chinese RCT reported a 3.35-point between-group difference; a severe-paresis pilot RCT found no significant three-month between-group difference, p=0.382 (S0195, S0194, S0203). This supports hospital-led evaluation of defined protocols, not universal efficacy.
FDA De Novo DEN200046 is a Class II, product-code QOL, 21 CFR 890.5420 regulatory record. NCT05965713 is completed with actual enrolment of 109 but still has no posted results (S0201, S0202). Neither fact establishes Chinese approval or adds an unpublished efficacy result.
Evidence and interpretation rules
Character or word rate, WER, classification accuracy, clinical scales, and task completion time measure different endpoints. Healthy and patient cohorts, random windows and held-out sessions, offline and online tests, and scalp and implanted signals remain separate. Cost ranking is limited to routes that meet the target and have an auditable cost boundary.
Audited scorecard entries
| Option | Scenario | Canonical label |
|---|---|---|
| RP01 | 科研平台 | 32-64通道专业EEG科研平台 |
| RP02 | 科研平台 | OpenBCI类8-16通道开放EEG平台 |
| AC01 | 辅助沟通 | 专业EEG P300辅助选择 |
| AC02 | 辅助沟通 | 开放EEG SSVEP有限选择 |
| DC01 | 设备控制 | 专业EEG共享控制 |
| DC02 | 设备控制 | 开放EEG P300/SSVEP共享控制 |
| RH01 | 康复 | 临床合作EEG-MI+FES |
| RH02 | 康复 | 临床合作EEG-MI+康复机器人 |
| RH03 | 康复 | 开放EEG-MI神经反馈研究 |
| CF01 | 认知/疲劳 | 专业EEG+眼动/ECG疲劳研究 |
| HCI01 | 自适应HCI | 专业EEG可撤销自适应HCI研究 |
| HCI03 | 自适应HCI | OpenBCI低后果自适应原型 |
Source catalog
221 normalized source records are available from the bilingual source library. Each entry retains its original title, authoritative URL, evidence boundary, rights status, and download availability. The Chinese controlled report remains the normative detailed edition.