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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
Recruitment status was: Recruiting
Sponsor:
Gabinete Berthier y Martínez
Collaborator:
H. Lundbeck A/S
Information provided by:
Gabinete Berthier y Martínez
ClinicalTrials.gov Identifier:
NCT00196703
First received: September 12, 2005
Last updated: NA
Last verified: March 2005
History: No changes posted
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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-Blind 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:
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 |
- 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 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00196703
Please refer to this study by its ClinicalTrials.gov identifier: 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:
| ClinicalTrials.gov Identifier: | NCT00196703 History of Changes |
| Other Study ID Numbers: |
10830 Gabinete Berthier y Martínez. Lundbeck, Spain, S.A. |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 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 |
ClinicalTrials.gov processed this record on August 16, 2017