Memantine and Constraint-Induced Language Therapy in Chronic Poststroke Aphasia:A Randomized Controlled Trial
Primary Purpose
Aphasia, Stroke
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
memantine
constraint-induced language therapy
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring Aphasia, Memantine, Constraint-induced language therapy, Event-related potentials
Eligibility 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)
Sites / Locations
- Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES) University of MalagaRecruiting
Outcomes
Primary Outcome Measures
Language function (overall aphasia severity).
Communication
Secondary Outcome Measures
Depression
Cognitive evaluation of language function
Changes in event-related potential
Full Information
NCT ID
NCT00196703
First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
Gabinete Berthier y Martínez
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT00196703
Brief Title
Memantine and Constraint-Induced Language Therapy in Chronic Poststroke Aphasia:A Randomized Controlled Trial
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 Type
Interventional
2. Study Status
Record Verification Date
March 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gabinete Berthier y Martínez
Collaborators
H. Lundbeck A/S
4. Oversight
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
Keywords
Aphasia, Memantine, Constraint-induced language therapy, Event-related potentials
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
memantine
Intervention Type
Procedure
Intervention Name(s)
constraint-induced language therapy
Primary Outcome Measure Information:
Title
Language function (overall aphasia severity).
Title
Communication
Secondary Outcome Measure Information:
Title
Depression
Title
Cognitive evaluation of language function
Title
Changes in event-related potential
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo L. Berthier, M.D., Ph.D.
Phone
(34) 952 22 45 90
Email
mberthier@terra.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo L. Berthier, M.D., Ph.D
Organizational Affiliation
Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES), University of Malaga
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES) University of Malaga
City
Malaga
ZIP/Postal Code
29001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo L. Berthier, M.D., Ph.D
Phone
(34) 952 22 45 90
Email
mberthier@terra.es
First Name & Middle Initial & Last Name & Degree
Cristina Green, Ph.D.
First Name & Middle Initial & Last Name & Degree
Carolina Higueras, Ph.D.
First Name & Middle Initial & Last Name & Degree
Pablo Lara, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Carmen Montes, M.D., Ph.D
First Name & Middle Initial & Last Name & Degree
Marcelo L. Berthier, M.D., Ph.D
12. IPD Sharing Statement
Citations:
PubMed Identifier
12105362
Citation
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.
Results Reference
background
PubMed Identifier
15537523
Citation
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.
Results Reference
background
PubMed Identifier
12847569
Citation
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.
Results Reference
background
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Memantine and Constraint-Induced Language Therapy in Chronic Poststroke Aphasia:A Randomized Controlled Trial
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