Safety and tolerability of temporal interference stimulation in humans: A systematic review and meta-analysis of an emerging deep neuromodulation technology.
Ilya Demchenko, Qiaowei Lin, Yesha Patel et al.
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In 30 seconds
This systematic review and meta-analysis assessed safety and tolerability of temporal interference stimulation (TIS) in human studies. It included 24 studies involving 853 participants: 21 randomised controlled trials and three non-randomised studies. No serious adverse events were reported. In parallel-arm trials, tingling was more frequent with active TIS than with control (RR = 2.95; 95% CI, 1.25-7.00; RD = 0.18; 95% CI, 0.01-0.34), while most other adverse-event effects were near null. Within-subject studies showed the highest pooled adverse-event estimates for fatigue, sleepiness, and tingling.
Key findings
- No serious adverse events were reported across the 24 included studies.
- In parallel-arm RCTs, tingling was more frequent with active TIS (RR = 2.95; 95% CI, 1.25-7.00; RD = 0.18; 95% CI, 0.01-0.34).
- Within-subject studies had the highest pooled adverse-event estimates for fatigue, sleepiness, and tingling.
Why it matters
Safety data are important as human use of this deep neuromodulation approach expands. The review suggests that reported effects were generally mild and transient, but tingling was more common with active stimulation in parallel-arm trials. These findings help characterise tolerability while underscoring that the available evidence covers a limited range of stimulation parameters and short-term applications.
What to keep in mind
Evidence was limited to conservative parameters (~2 kHz; ≤2 mA/channel), small sample sizes, and short-term TIS applications.