FOI release

FOI request: GB-PRIME study

This request was refused in full, so we didn't provide the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00168

Received 16 February 2026

Published 8 May 2026

Request

Under the Freedom of Information Act 2000, I am requesting information regarding the GB-PRIME study (ClinicalTrials.gov ID: NCT07127172; IRAS ID: 354112), specifically concerning the Neuralink N1 Brain-Computer Interface and the R1 Surgical Robot. • I request the following information: • The total number of Serious Adverse Events (SAEs) reported to the MHRA in relation to this study from its commencement in the UK through February 2026. • The number of reported incidents of electrode thread retraction or displacement in UK participants. • The number of surgical site infections or secondary surgeries required for any UK trial participants. • A copy of the non-technical summary of the clinical trial authorization, including any specific safety conditions imposed by the MHRA for the UK arm of the study. I understand that personal data is exempt under Section 40, and I am not seeking the identities of any participants. Moreover, while I recognise commercial sensitivity (Section 43), I believe the public interest in the safety of invasive neurological implants outweighs the commercial interest in withholding aggregate safety figures.

Response

See attached

Documents

• FOI2026_00168 (redacted).pdf (1.0 MB)

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