In this double-blind balloon conducted at eight all-embracing centers, we about assigned patients in a 3:1 arrangement to abide focused ultrasound thalamotomy or a adulterated activity in which no acoustic activity was delivered. The primary abstraction end point was the change in agitation from baseline to 3 months, analyzed on the base of videotaped assessments. Afterwards 3 months, patients in the sham-procedure accumulation could cantankerous over to alive assay (Fig. S2 in the Supplementary Appendix).
Representatives of the architect of the focused ultrasound arrangement acclimated in the abstraction (InSightec) provided abstraction blank and abstruse abutment and acquired civic authoritative permissions. Absolute institutional approval of the abstraction was acquired by the assay aggregation at anniversary accommodating center, and all patients gave accounting a consent. Clinical blank of the balloon was provided by the arch investigator and an absolute abstracts and assurance ecology board. The authors vouch for the accuracy and abyss of the abstracts and abstracts analyses. The aboriginal columnist wrote the aboriginal abstract of the manuscript, and all authors fabricated the accommodation to abide the arrangement for publication. The abstraction was conducted with allegiance to the abstraction protocol, which is accessible at NEJM.org.
Patients with capital tremor, diagnosed by a neurologist specializing in movement disorders, were enrolled on the base of accommodation belief that accept been declared previously.24 Briefly, patients were acceptable if they had a postural or ambition agitation of the duke that was abstinent to astringent (defined by a account of ≥2 on the Clinical Appraisement Calibration for Tremor26 [CRST; array ambit from 0 to 4 per basic adjourned and college array announce added astringent tremor]) and disabling (defined by a account of ≥2 on any of the eight items in the affliction annex of the CRST [scores ambit from 0 to 4 per item, and college array announce greater disability]). Added accommodation belief were agitation that was adverse to at atomic two trials of medical therapy, including at atomic one first-line abettor (propranolol or primidone). For patients accepting circumstantial medical therapy, medication doses had to be abiding for 30 canicule afore randomization. Patients were afar if they had a neurodegenerative condition, ambiguous cardiac disease, coagulopathy, accident factors for deep-vein thrombosis, astringent abasement (defined by a account ≥20 on Accommodating Health Questionnaire 9 [scores ambit from 0 to 27, with college array advertence added astringent depression]), or cerebral crime (defined by a account of <24 on the Mini–Mental State Examination [scores ambit from 0 to 30, with lower ethics advertence greater impairment]) or if they had undergone a antecedent academician activity (transcranial alluring stimulation, deep-brain stimulation, stereotactic lesioning, or electroconvulsive therapy). A skull body arrangement (the arrangement of cortical to cancellous bone) of 0.45 or added was appropriate from the screening computed tomographic (CT) scan.
From August 2013 through September 2014, we enrolled 81 patients and about assigned them to a abstraction group. Bristles of these patients were afar afore ability the assigned activity because they met absolute criteria, as abundant in Fig. S2 in the Supplementary Appendix. As predefined in the agreement and statistical assay plan, alone the 76 patients in whom the abstraction activity was attempted or completed were included in the adapted intention-to-treat analysis.
The capacity of focused ultrasound thalamotomy accept been declared previously.23-25 Briefly, patients were placed in a stereotactic arch anatomy that was accompanying to an MRI-compatible ultrasound transducer. Afterwards stereotactic targeting with the use of MRI, acoustic activity was sequentially titrated to temperatures acceptable for tissue ablation (approximately 55 to 60°C). Anniversary abrupt sonication was monitored with alluring resonance thermometry, and the accommodating was clinically adjourned for agitation abridgement and adverse furnishings (for details, see the description in the Supplementary Appendix).
For patients about assigned to abide a adulterated procedure, an identical activity was performed with a randomized cardinal of sonications for which the acoustic ability was able so that no acoustic activity was delivered to the brain. Alone the assay aggregation was acquainted of the accumulation assignments; patients and assessors were blind of the assignments.
Tremor assessments, based on the CRST,26 were performed at anniversary armpit by a movement-disorder specialist, and anatomic cachet was bent on the base of the appraisement for the affliction annex (Part C) of the CRST, as able-bodied as the disease-specific, self-reported Affection of Activity in Capital Agitation Questionnaire (QUEST).27 Agitation evaluations were videotaped for primary assay by an absolute amount accumulation of neurologists (Tremor Assay Group) at baseline and at 1, 3, 6, and 12 months afterwards treatment.
The primary ability aftereffect admeasurement was authentic as the change from baseline to 3 months in the agitation account for the duke in the thalamotomy accumulation as compared with the sham-procedure group. The agitation account (on a calibration alignment from 0 to 32, with college array advertence added astringent tremor) was acquired from the CRST, Part A (three items: resting, postural, and activity or ambition apparatus of duke tremor), and the CRST, Part B (five tasks involving handwriting, drawing, and pouring), in the duke contralateral to the thalamotomy.
The three prespecified accessory ability measures were anatomic limitations in circadian activities, abstinent according to eight items in the affliction annex of the CRST (maximum all-embracing score, 32; college array announce greater disability); affection of life, adjourned with the QUEST at 3 months; and the backbone of the abridgement in duke agitation at 12 months. We additionally performed a column hoc assay of absolute agitation array (maximum all-embracing account for the best astringent tremor, 152 credibility afterwards collapsed assessments). Assurance was adjourned throughout the abstraction on the base of appear adverse events. MRI was performed anon afterwards the abstraction activity and at 12 months.
The abstraction participants and the neurologist at anniversary armpit were blind of the assay assignments throughout the aboriginal 3 months, and the primary assessors of the videotaped agitation evaluations were not complex in the abstraction treatments and were blind of the assay assignments and the ancillary that was advised (left vs. right). Since the patients’ active were not covered, the assessors could see whether the videotapes showed preoperative or postoperative agitation evaluations; however, they could not actuate whether the videotapes were taken 1, 3, 6, or 12 months afterwards treatment.
We affected the sample admeasurement from pilot-study observations, accounting for a abeyant dropout amount of 20%. The absent antecedent was that thalamotomy would be either the aforementioned as or inferior to the adulterated activity with account to the allotment advance in the primary end point. The another antecedent was that thalamotomy would be above to the adulterated procedure. Given a sample of at atomic 60 patients, the abstraction had about 100% ability to appearance the primary ability of thalamotomy, assuming, on the base of actual results, boilerplate improvements of 78% and 4% in the thalamotomy and sham-procedure groups, appropriately (standard deviation, 25%). Ability calculations were performed with the use of an independent-groups t-test, with a randomization arrangement of 3:1 for appointment to thalamotomy against the adulterated procedure. The anticipation of audition an adverse accident amount of 1% was 0.45, and the anticipation of a 5% amount was 0.95. The statistical assay was planned and conducted with the abetment of the biostatistics aggregation at TechnoSTAT. The statistical assay plan (see the abstraction protocol) was accustomed by the Food and Drug Administration (FDA).
We acclimated a hierarchical testing architecture to ascendancy for assorted comparisons beyond the one primary and three prespecified accessory end points. The primary ability assay was accepted at an alpha akin of 0.05, and again anniversary of the three accessory ability end credibility was activated at an alpha akin of 0.05. No acknowledging statements were fabricated about added end points. Thus, blazon 1 absurdity was controlled beyond all end credibility activated in this study.
A acuteness assay with assorted allegation was planned, but in the primary analysis, alone two patients had missing data. Since worst-case and best-case scenarios yielded such agnate results, added allegation was not agitated out. A additional acuteness analysis, performed because bristles patients were begin to accommodated exclusion belief afterwards randomization, accepted that their exclusion had no aftereffect on the after-effects of the primary aftereffect assay (see the Supplementary Appendix). The abstracts appear actuality were bound on September 17, 2015, and the address was accomplished on October 14, 2015.
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