Memantine and Intensive Speech-Language Therapy in Aphasia
Condition: Aphasia; Stroke
MeSH terms: Aphasia
Study type: Interventional
Phase: Phase 4

Summary: 
      -  Aphasia, the loss or impairment of language caused by brain damage, is one of the most
           devastating cognitive impairments of stroke. Aphasia can be treated with combination of
           speech-language therapy and drugs. Conventional speech-language therapy in chronic
           aphasic subjects is of little help and several drugs have been studied with limited
           success. Therefore other therapeutic strategies are warranted.

        -  Recent data suggest that drugs (memantine) acting on the brain chemical glutamate may
           help the recovery of cognitive deficits, included language, in subjects with vascular
           dementia. The present study examines the safety profile and efficacy of memantine paired
           with intensive language therapy in subjects with stroke-related chronic aphasia (more
           than 1 yr. of evolution).
    

Detailed description: 
      -  The efficacy of drugs that act on glutamate such as the N-methyl-D-aspartic acid (NMDA)
           receptor antagonist memantine requires to be explored in this population. The rationale
           for using memantine in post-stroke aphasia comes from recent studies on vascular
           dementia. Data extracted from a recent Cochrane review of randomized controlled trials
           of memantine in different types of dementia (vascular dementia, Alzheimer's disease,
           mixed dementia) reveal, after 6 weeks of treatment, beneficial effects on cognition
           (including language), activities of daily living, behavior and global scales as well as
           in the global impression of change.

        -  Recovery from aphasia is possible even in severe cases. While speech-language therapy
           remains as the mainstay treatment of aphasia, its effectiveness has not been
           conclusively proved. This has motivated the planning of more rational therapies (e.g.,
           constraint-induced language therapy [Pulvermüller et al., 2001; 32: 1621-1626]).

        -  In addition, the neural correlates of improvement of language function can now be
           readily detectable with event-related potentials. This is a noninvasive technique that
           can detect in real time functional brain changes during recovery promoted by the
           combined action of memantine and constraint-induced language therapy.

        -  The aim of the present study is to assess the efficacy, safety profile, and functional
           correlates of memantine paired with massed language therapy in a sample of patients with
           chronic poststroke aphasia.
    

Intervention name(s): memantine; constraint-induced language therapy (CIAT); memantine; placebo
Intervention type(s): Drug; Behavioral; Drug; Drug
Intervention description(s): Memantine was titrated in 5-mg weekly increments as recommended,from a starting dose of 5 mg/day to 20 mg/day. After the 3-week up-titration phase all patients received a fixed dose of either memantine (10 mg) or placebo twice daily without CIAT during the next 3 months (week 16). During the next 2 weeks (weeks 16-18), the drug treatment was combined with CIAT. This phase of combined treatment was followed by a 2-week period (weeks 18-20) where patients received memantine or placebo treatment alone and, finally, by a 4-week period of drug withdrawal (weeks 20-24); CIAT is an intensive form of language-action therapy for aphasia performed in a small group setting. In a therapeutic game context, participants had to request objects or cards from each other and understand requests made by others. Feedback of communicative success was regularly given, along with guidance, help and reinforcement. Gesturing replacing verbal language was discouraged although gestures accompanying speech were allowed. Difficulty levels were adjusted to the patients´ communicative abilities by choosing language materials and actions and reinforcement was administered taking into account each patient´s level of performance. Communication rules were introduced by shaping and modelling. Each patient received 30 hours of therapy.; Memantine was titrated in 5-mg weekly increments as recommended, from a starting dose of 5 mg/day to 20 mg/day. After the 3-week up-titration phase all patients received a fixed dose of either memantine (10 mg) or placebo twice daily without CIAT during the next 3 months (week 16). During the next 2 weeks (weeks 16-18), the drug treatment was combined with CIAT. This phase of combined treatment was followed by a 2-week period (weeks 18-20) where patients received memantine or placebo treatment alone and, finally, by a 4-week period of drug withdrawal (weeks 20-24).; Placebo
Other intervention name(s): Ebixa, Namenda; Intensive language-action therapy; Ebixa, Namenda
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Aphasia; Memantine; Constraint-induced language therapy; Event-related potentials