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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2005 by Gabinete Berthier y Martínez.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00196703

First Posted: September 20, 2005

Last Update Posted: December 9, 2005

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

H. Lundbeck A/S

Information provided by:

Gabinete Berthier y Martínez

Purpose

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	Intervention	Phase
Aphasia Stroke	Drug: memantine Procedure: constraint-induced language therapy	Phase 4


Study Type:	Interventional
Study Design:	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.

Resource links provided by NLM:

MedlinePlus related topics: Aphasia

Drug Information available for: Memantine Memantine hydrochloride

U.S. FDA Resources

Further study details as provided by Gabinete Berthier y Martínez:

Primary Outcome Measures:

Language function (overall aphasia severity).
Communication

Secondary Outcome Measures:

Depression
Cognitive evaluation of language function
Changes in event-related potential


Estimated Enrollment:	30
Study Start Date:	March 2005
Estimated Study Completion Date:	September 2005

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.

Eligibility

Information from the National Library of Medicine

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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

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

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 Submitted:	September 12, 2005
First Posted:	September 20, 2005
Last Update Posted:	December 9, 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

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