By Elena Moro
For June 2017, we have selected: Breitenstein C, Flöel A, Ziegler W, et al., for the FCET2EC study group. Intensive speech and language therapy in patients with chronic aphasia after stroke: a randomized, open-label, blinded-endpoint, controlled trial in health-care setting. Lancet Neurol 2017;389:1528-1538.
Speech and language impairments are among the most disabling symptoms after a stroke. Patients with aphasia persisting 6 months (chronic aphasia) after a stroke are not infrequent (20%). Hence, the social and economic impact of chronic aphasia is substantial. Clinical evidence has stressed the effectiveness of intensive speech and language therapy both in the early and chronic post-stroke stages. However, large randomized controlled trials have not been available to further support the use of intensive speech rehabilitation (5-10 hours per week) in the common management of patients with chronic aphasia after stroke.
A randomized multicenter, open-label, blinded end-point, controlled trial was conducted in 19 German inpatient or outpatient rehabilitation centers specialized in stroke rehabilitation. The main outcome was to study the efficacy of 3 weeks or more of intensive (≥10 h per week) speech and language therapy in chronic aphasia patients after stroke compared to 3 weeks of delayed treatment. Patients with aphasia persistent ≥6 months after ischemic (82%)or hemorrhagic stroke (18%), age 18-70 years, with basic comprehension abilities and basic attempts to verbally communicate were enrolled. Speech and language therapy was offered by overall 40 professional therapists as part of routine clinical care, merging linguistic and communicative-pragmatic approaches individualized to the baseline profile of each patient. Treatment was provided for 3 weeks or more, 10 hours or more per week, in one-to-one and group therapy sessions, and 5 hours or more per week self-managed training targeting individual linguistic deficits. The control group was assigned to the same treatment after 3-week waiting period (although they could continue to have conventional low-intensity speech therapy), and reassessed afterwards. Both groups were finally evaluated at 6 months after completion of the 3-week intensive therapy. Moreover, a subgroup of patients from both groups had 5 weeks or more of intensive treatment. The primary outcome, effectiveness of verbal communication in the everyday life situations, was assessed using the two parallel versions of the Amsterdam-Nijmegen Everyday Language Test (ANELT) A-scale. Off line assessment was provided by eight independent raters, masked to group assignment, by random labelling respective audio files using ANELT. Secondary outcomes were changes in ANELT A-scale at 6 months in both groups, and after the 3-week intensive therapy in the control group. Moreover, auditory intelligibility in everyday communication (ANELT B-scale), impairment specific language measures (SAPS), stroke and aphasia quality of life scale-39 (SAQOL-39), non-verbal learning, and other cognitive functions were assessed.
Within a 2-year period, 158 patients were randomized 1:1 in the two groups. After 3 weeks of intensive therapy (a median of 31 hours per week) the mean difference since baseline in ANELT A-scale was significantly larger (2.61 points, 95% CI 1.49-3.72) than after 3 weeks of treatment deferral (-0.03 points, -094-0.88, p=0.0004). The control group showed similar improvement after the 3-week intensive intervention. Moreover, the subgroup analysis of 34 patients who had ≥5 weeks intensive speech and language therapy revealed a mean change in the ANELT A-scale 1 point larger compared to the 3-week intervention (4.23 points, 95% 2.74-5.73). SAPS and SAQOL-39 were significantly improved after the 3-week treatment, and at 6 months. Baseline stroke severity was negatively correlated to treatment success in verbal communication.
“This study demonstrates that intensive speech and language treatment for at least 3 weeks improves verbal communication in everyday life scenario in patients with chronic aphasia after stroke, regardless of age or months since stroke”, says Prof. Maurice Giroud, Stroke Unit, Dijon, France. “These findings stress the importance of rigorous rehabilitation (≥ 10 hours per week over ≥ 3 weeks) for aphasia patients, with remarkable impact beyond the early post-stroke conventional rehabilitation period.”
“Importantly, communication-related quality of life items were also significantly improved by intensive speech and language therapy provided under routine clinical conditions,” says Dr. Elena Lebedeva, Department of Neurology, Yekaterinburg, Russian Federation. “These changes are very relevant and should be considered while planning post-stroke management of patients with aphasia.”
The other nominees for the June’s paper of the month are:
- Relkin NR, Thomas RG, Rissman RA, et al., for the Alzheimer’s disease Cooperative Study. A phase 3 trial of IV immunoglobuline for Alzheimer disease. Neurology 2017; 88:1768–1775. In this phase 3, double-blind, placebo-controlled trial, biweekly infusions of IV immunoglobulin were administered in patients with mild to moderate Alzheimer disease (AD) for 18 months. At this time-point, there were no differences in the cognitive items of the Alzheimer’s Disease Assessment Scale, and in the Alzheimer’s Disease Cooperative Study–Activities of Daily Living Inventory compared to baseline.
- Murthy SB, Gupta A, Merkel AE, et al. Restarting anticoagulant therapy after intracranial hemorrhage. Stroke 2017;48:00-00. DOI: 10.1161/
STROKEAHA.116.016327. This meta-analysis included eight studies involving 5,306 patients with intracranial hemorrhage associated to anticoagulation treatment. Reinitiating anticoagulation therapy was linked to a lower risk of thromboembolic complications, and no increased risk of recurrent intracranial hemorrhage.
- Wissel J, Bensmail D, Ferreira JJ, et al, on behalf of the TOWER study investigators. Safety and efficacy of incobotulinumtoxinA doses up to 800 U in limb spasticity. The TOWER study Neurology 2017;88:1321-1328. In this prospective, single arm, dose titration study, both efficacy and safety of incobotulinumtoxinA were assessed in 155 patients with limb spasticity. The three consecutive injections cycles with 400 U, 600 U, and 800 U of incobotulinumtoxinA were well tolerated, and associated with better clinical improvement.