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

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ClinicalTrials.gov Identifier: NCT00196703
Recruitment Status : Unknown
Verified March 2005 by Gabinete Berthier y Martínez.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
Sponsor:
Collaborator:
Information provided by:

September 12, 2005
September 20, 2005
September 20, 2005
March 2005
Not Provided
  • Language function (overall aphasia severity).
  • Communication
Same as current
No Changes Posted
  • Depression
  • Cognitive evaluation of language function
  • Changes in event-related potential
Same as current
Not Provided
Not Provided
 
Memantine and Constraint-Induced Language Therapy in Chronic Poststroke Aphasia:A Randomized Controlled Trial
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.
  • 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).
  • 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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Aphasia
  • Stroke
  • Drug: memantine
  • Procedure: constraint-induced language therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
September 2005
Not Provided

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)
Sexes Eligible for Study: All
18 Years to 69 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00196703
10830
Gabinete Berthier y Martínez.
Lundbeck, Spain, S.A.
Not Provided
Not Provided
Not Provided
Not Provided
Gabinete Berthier y Martínez
H. Lundbeck A/S
Principal Investigator: Marcelo L. Berthier, M.D., Ph.D Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES), University of Malaga
Gabinete Berthier y Martínez
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP