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Memantine and Constraint-Induced Language Therapy in Chronic Poststroke Aphasia:A Randomized Controlled Trial

This study is currently recruiting participants.
Study NCT00196703.   Last updated on September 12, 2005.   Information provided by Gabinete Berthier y Martínez

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Descriptive Information Fields
Brief Title  Memantine and Constraint-Induced Language Therapy in Chronic Poststroke Aphasia:A Randomized Controlled Trial
Official Title  A 24-Week Pilot, Double-Blind, Randomized, Parallel, Placebo-Controlled Study of Memantine and Constraint-Induced Language Therapy in Chronic Poststroke Aphasia:Correlation With Cognitive Evoked Potentials During Recovery.
Brief 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.
Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Language function (overall aphasia severity).
Communication
Secondary Outcome Measure  Depression
Cognitive evaluation of language function
Changes in event-related potential
Condition  Aphasia
Stroke
Intervention  Drug: memantine
Procedure: constraint-induced language therapy
MEDLINE PMIDs 12105362,   15537523,   12847569
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  30
Start Date  March 2005
Completion Date September 2005
Eligibility Criteria 

Inclusion Criteria:

  • Chronic aphasia of more than one year duration
  • Must be able to complete protocol

Exclusion Criteria:

  • Dementia
  • Major psychiatric illness
  • Severe global aphasia (precludes participation in constraint-induced language therapy)
Gender Both
Ages 18 Years to 69 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Marcelo L. Berthier, M.D., Ph.D.     (34) 952 22 45 90     mberthier@terra.es    
Location Countries  Spain
Administrative Information Fields
NCT ID  NCT00196703
Organization ID 10830
Secondary IDs †† Gabinete Berthier y Martínez., Lundbeck, Spain, S.A.
Study Sponsor  Gabinete Berthier y Martínez
Collaborators †† H. Lundbeck A/S
Investigators 
Principal Investigator:     Marcelo L. Berthier, M.D., Ph.D     Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES), University of Malaga    
Information Provided By Gabinete Berthier y Martínez
Verification Date March 2005
First Received Date  September 12, 2005
Last Updated Date September 12, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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