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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:
H. Lundbeck A/S
Information provided by:
Gabinete Berthier y Martínez

Study Description
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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).

Condition or disease Intervention/treatment Phase
Aphasia Stroke Drug: memantine Procedure: constraint-induced language therapy Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : March 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Language function (overall aphasia severity).
  2. Communication

Secondary Outcome Measures :
  1. Depression
  2. Cognitive evaluation of language function
  3. Changes in event-related potential

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196703


Contacts
Contact: Marcelo L. Berthier, M.D., Ph.D. (34) 952 22 45 90 mberthier@terra.es

Locations
Spain
Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES) University of Malaga Recruiting
Malaga, Spain, 29001
Contact: Marcelo L. Berthier, M.D., Ph.D    (34) 952 22 45 90    mberthier@terra.es   
Sub-Investigator: Cristina Green, Ph.D.         
Sub-Investigator: Carolina Higueras, Ph.D.         
Sub-Investigator: Pablo Lara, M.D., Ph.D.         
Sub-Investigator: Carmen Montes, M.D., Ph.D         
Principal Investigator: Marcelo L. Berthier, M.D., Ph.D         
Sponsors and Collaborators
Gabinete Berthier y Martínez
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
More Information
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Publications:

ClinicalTrials.gov Identifier: NCT00196703     History of Changes
Other Study ID Numbers: 10830
Gabinete Berthier y Martínez.
Lundbeck, Spain, S.A.
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 20, 2005
Last Verified: March 2005

Keywords provided by Gabinete Berthier y Martínez:
Aphasia
Memantine
Constraint-induced language therapy
Event-related potentials

Additional relevant MeSH terms:
Communication Disorders
Aphasia
Speech Disorders
Language Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Memantine
 Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents