Global clinical development of transcranial temporal interference stimulation: an analysis of registered human trials
Transcranial temporal interference stimulation (tTIS) is a noninvasive approach intended to engage deep or distributed brain targets. Despite a growing number of human studies, the global landscape, design characteristics, and reporting practices of registered tTIS trials remain unclear. We characterized the global clinical development of tTIS by examining registration trends, trial design, intervention reporting, and result availability. We searched nine international and regional clinical trial registries through April 30, 2026, to identify human interventional trials involving tTIS or related transcranial interferential stimulation approaches. Eligible records were deduplicated and coded for geography, indication, intended target, enrollment, design, stimulation parameters, device or platform information, safety reporting, and result availability. From 1,548 records, 168 unique trials were included. Registrations increased markedly after 2023 and were concentrated in China (79.8%) and the United States (11.3%). Psychiatric disorders were the leading indication group (39.8%), and target information was not reported in 75 trials (44.6%). Among reported targets, subcortical structures predominated. Most trials involved a single center (94.6%), and 51.8% planned to enroll fewer than 50 participants. Randomization, masking, and sham control were reported in 69.6%, 74.4%, and 66.7% of trials, respectively. Among stimulation parameters, session duration was reported most frequently (40.5%). Device or platform information was reported in 12.5% of trials. At the data cutoff, 13 trials (7.7%) were classified as completed or terminated. Results were available for 8 trials (4.8%) from 10 sources. Registered tTIS research is expanding rapidly across diverse indications and intended targets, while clinical development remains at an early stage and intervention reporting remains incomplete. Greater transparency and consistency in trial registration and intervention documentation will enhance comparability across trials, facilitate protocol replication and evidence synthesis, and support the development of a more coherent evidence base for tTIS.
Authors
- Cong Fu (ORCID: https://orcid.org/0000-0002-8937-3326)
- Liqun Jiao (ORCID: https://orcid.org/0000-0003-4982-6295)
- Yan Ma (ORCID: https://orcid.org/0000-0001-6164-2291)
- 张晓华
- Rui Liu (ORCID: https://orcid.org/0000-0002-1642-1243)
- Lei Cao (ORCID: https://orcid.org/0000-0002-1464-4865)
- Jiaqi Jin
- Shihao Jiang (ORCID: https://orcid.org/0009-0005-6626-8784)
- Linlin Ye (ORCID: https://orcid.org/0000-0002-5035-8989)
- Xuesong Bai
- Fuchao Yu
- Zexing Li
- Tao Wang
- Tianyu Wang
Institutions
- Capital Medical University (CN)
- Xuan Wu Hospital of the Capital Medical University (CN)
- Liaocheng People's Hospital (CN)
- Shandong First Medical University (CN)
Publication Details
- Journal
- BMC Medicine
- Published
- 2026-10-31
- DOI
- https://doi.org/10.1186/s12916-026-05363-0
- Primary Topic
- Transcranial Magnetic Stimulation Studies
- Type
- article
- Field-Weighted Citation Impact
- 0.00