2005 - New Memantine Trial - Memantine and Constraint-Induced Language Therapy in Chronic Poststroke Aphasia:A Randomized Controlled Trial
Memantine and Constraint-Induced Language Therapy in Chronic Poststroke Aphasia:A Randomized Controlled Trial
This study is currently recruiting patients.
Verified by Gabinete Berthier y Martínez March 2005
Sponsors and Collaborators: Gabinete Berthier y Martínez
Lundbeck España S.A.
Information provided by: Gabinete Berthier y Martínez
ClinicalTrials.gov Identifier: NCT00196703
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 IV
MedlinePlus related topics: Aphasia; Stroke
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.
Further Study Details:
Primary Outcomes: Language function (overall aphasia severity).; Communication
Secondary Outcomes: Depression; Cognitive evaluation of language function; Changes in event-related potential
Expected Total Enrollment: 30
Study start: March 2005
Last follow-up: September 2005
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
Ages Eligible for Study: 18 Years - 69 Years, Genders Eligible for Study: Both
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)
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00196703
Marcelo L. Berthier, M.D., Ph.D. (34) 952 22 45 90 mberthier@terra.es
Spain
Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES) University of Malaga, Malaga, 29001, Spain; Recruiting
Marcelo L. Berthier, M.D., Ph.D (34) 952 22 45 90 mberthier@terra.es
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, Sub-Investigator
Marcelo L. Berthier, M.D., Ph.D, Principal Investigator
Study chairs or principal investigators
Marcelo L. Berthier, M.D., Ph.D, Principal Investigator, Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES), University of Malaga
More Information
Publications
Orgogozo JM, Rigaud AS, Stoffler A, Mobius 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.
Roman G. Perspectives in the treatment of vascular dementia. Drugs Today (Barc). 2000 Sep;36(9):641-53.
Study ID Numbers: 10830; Gabinete Berthier y Martínez.; Lundbeck, Spain, S.A.
Last Updated: September 19, 2005
Record first received: September 12, 2005
ClinicalTrials.gov Identifier: NCT00196703
Health Authority: Spain: Ministry of Health and Consumption
ClinicalTrials.gov processed this record on 2005-10-05
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