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

NCT ID: NCT00196703

Last Updated: 2005-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-09-30

Brief Summary

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* 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).

Detailed Description

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* 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.

Conditions

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Aphasia Stroke

Keywords

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Aphasia Memantine Constraint-induced language therapy Event-related potentials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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memantine

Intervention Type DRUG

constraint-induced language therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role collaborator

Gabinete Berthier y Martínez

OTHER

Sponsor Role lead

Principal Investigators

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Marcelo L. Berthier, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES), University of Malaga

Locations

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Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES) University of Malaga

Málaga, Malaga, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Marcelo L. Berthier, M.D., Ph.D.

Role: CONTACT

Phone: (34) 952 22 45 90

Email: [email protected]

Facility Contacts

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Marcelo L. Berthier, M.D., Ph.D

Role: primary

References

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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. doi: 10.1161/01.str.0000020094.08790.49.

Reference Type BACKGROUND
PMID: 12105362 (View on PubMed)

Pantoni L. Treatment of vascular dementia: evidence from trials with non-cholinergic drugs. J Neurol Sci. 2004 Nov 15;226(1-2):67-70. doi: 10.1016/j.jns.2004.09.014.

Reference Type BACKGROUND
PMID: 15537523 (View on PubMed)

Roman G. Perspectives in the treatment of vascular dementia. Drugs Today (Barc). 2000 Sep;36(9):641-53. doi: 10.1358/dot.2000.36.9.593781.

Reference Type BACKGROUND
PMID: 12847569 (View on PubMed)

Other Identifiers

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Gabinete Berthier y Martínez.

Identifier Type: -

Identifier Source: secondary_id

Lundbeck, Spain, S.A.

Identifier Type: -

Identifier Source: secondary_id

10830

Identifier Type: -

Identifier Source: org_study_id