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

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

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, Senior)
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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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:

Orgogozo JM, Rigaud AS, Stöffler A, Möbius HJ, Forette F. Efficacy and safety of memantine in patients with mild to moderate vascular dementia: a randomized, placebo-controlled trial (MMM 300). Stroke. 2002 Jul;33(7):1834-9.

Pantoni L. Treatment of vascular dementia: evidence from trials with non-cholinergic drugs. J Neurol Sci. 2004 Nov 15;226(1-2):67-70. Review.

Romàn G. Perspectives in the treatment of vascular dementia. Drugs Today (Barc). 2000 Sep;36(9):641-53.

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
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