Caudate deep brain stimulation for treatment-resistant tinnitus: Phase 1

Record details

Authors: Cheung SW, et al.
Journal / source: Journal of Neurosurgery (2019)
Design: Open-label Phase 1 safety/feasibility; bilateral caudate DBS, 24 weeks; NCT01988688
Sample: 6 implanted, 5 completed
Primary endpoint: Safety; TFI/THI change (exploratory)
Randomized: No · Sham/placebo-controlled: No · Independent of the manufacturer: Yes

What this research found

TFI improved a mean 23.3 points and THI 30.8 (responders 3/5 and 4/5); no significant neuropsychological or hearing changes. Invasive brain surgery, N=5, unblinded — feasibility data only.

Hypothesis-generating for the most refractory cases; no efficacy claim possible from an open-label five-person series.

Limitations and conflicts of interest

N=5, open-label, invasive.

Funding / conflicts: Independent (academic).

Primary sources

Context record — informs the platform without serving as treatment evidence.

This is an original summary from the Tinnitus Evidence verified database, checked against the primary source — not a reproduction of the publisher's abstract.