A Randomised Controlled Trial of Intensive Aphasia Therapy after Acute Stroke: The Very Early Rehabilitation for Speech (Verse) Study

Background: The effectiveness of early intensive aphasia rehabilitation over usual care after stroke is unknown. The Very Early Rehabilitation for Speech (VERSE) trial aimed to determine whether intensive aphasia therapy, beginning within 15 days after stroke onset, improved communication recovery at 12 weeks compared to usual aphasia care. Methods: This prospective, randomised, single-blinded trial was conducted at 17 acute-care hospitals across Australia/New Zealand. Participants with aphasia were randomised to receive Usual Care (UC) (direct usual care aphasia therapy), or one of two higher intensity regimens - Usual Care-Plus ([UC-Plus], UC plus 20 sessions of non-prescribed direct aphasia therapy) or VERSE therapy (UC plus 20 sessions of prescribed direct aphasia therapy). Our preplanned intention to treat analysis combined both high intensity groups for the primary outcome. The Primary outcome was improvement in communication at 12 weeks after stroke, on the Western Aphasia Battery Aphasia Quotient (AQ). Findings: Among 13,654 patients screened, 25% (3,477) had aphasia, of which 25% (866) were eligible. Between June 4th, 2014 and February 10th, 2018, 246 participants were recruited and randomised to UC (n=81), UCPlus (n=82) and VERSE (n=83). At the primary endpoint, 29 (12%) participants were either deceased (14) or withdrew (15). No between group difference (p = 0∙72) was noted in non-fatal or fatal adverse events. The observed communication recovery was 50.3% (95% confidence interval [CI]: 45∙7 to 54∙8) in the high intensity group and 52∙1% (95%CI: 46.1 to 58.1) in the UC group (difference -1.9, CI: -8∙7 to 5∙0). Interpretation: Early intensive aphasia therapy after acute stroke did not result in greater improvement in communication recovery than lower intensity usual care at 12 weeks post stroke. Clinical Trial Number: The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000776707); and Universal Trial Number (U1111-1145-4130). Funding Statement: National Health and Medical Research Council (APP1044973), The Tavistock Trust for Aphasia, Edith Cowan University Declaration of Interests: EG and BA report grants from the National Health and Medical Research Council (NHMRC), The Tavistock Trust for Aphasia and Edith Cowan University during the conduct of the study. FE reports personal fees from Florey Institute of Neurosciences and Mental Health - The University of Melbourne during the conduct of the study. JB and SM report other grants from the NHMRC during the conduct of the study. SM was a member of the NHMRC Research Committee during conduct of this trial but appointed after awarding of these funds. GJH has received honoraria from Bayer for lecturing at sponsored scientific symposia and consulting on advisory boards about stroke prevention in atrial fibrillation. MR, TR, DC, NC, EA and AW declare no competing interests. Ethics Approval Statement - All adverse events were registered as per the VERSE protocol,8 adjudicated by an independent medical officer and reported to the Data Safety and Monitoring Board.