Three-year follow-up of prospective trial of focused ultrasound thalamotomy for essential tremor.
Aged; Aged, 80 and over; Cohort Studies; Cross-Over Studies; Essential Tremor; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Psychosurgery; Single-Blind Method; Surveys and Questionnaires; Thalamus; Time Factors; Ultrasonic Therapy
OBJECTIVE: To test the hypothesis that transcranial magnetic resonance-guided focused ultrasound (tcMRgFUS) thalamotomy is effective, durable, and safe for patients with medication-refractory essential tremor (ET), we assessed clinical outcomes at 3-year follow-up of a controlled multicenter prospective trial.
METHODS: Outcomes were based on the Clinical Rating Scale for Tremor, including hand combined tremor-motor (scale of 0-32), functional disability (scale of 0-32), and postural tremor (scale of 0-4) scores, and total scores from the Quality of Life in Essential Tremor Questionnaire (scale of 0-100). Scores at 36 months were compared with baseline and at 6 months after treatment to assess for efficacy and durability. Adverse events were also reported.
RESULTS: Measured scores remained improved from baseline to 36 months (all
CONCLUSIONS: Results at 3 years after unilateral tcMRgFUS thalamotomy for ET show continued benefit, and no progressive or delayed complications. Patients may experience mild degradation in some treatment metrics by 3 years, though improvement from baseline remains significant.
CLINICALTRIALSGOV IDENTIFIER: NCT01827904.
CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with severe ET, unilateral tcMRgFUS thalamotomy provides durable benefit after 3 years.
Neurosciences (Brain & Spine)
Halpern, Casey H; Santini, Veronica; Lipsman, Nir; Lozano, Andres M; Schwartz, Michael L; Shah, Binit B; Elias, W Jeff; Cosgrove, Garth R; Hayes, Michael T; McDannold, Nathan; Aldrich, Christina; Eisenberg, Howard M; Gandhi, Dheeraj; Taira, Takaomi; Gwinn, Ryder; Ro, Susie; Witt, Jennifer; Jung, Na Young; Chang, Jin Woo; Rosenberg, Jarrett; and Ghanouni, Pejman, "Three-year follow-up of prospective trial of focused ultrasound thalamotomy for essential tremor." (2019). Articles, Abstracts, and Reports. 2808.