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Memantine and Intensive Speech-Language Therapy in Aphasia

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
Gabinete Berthier y Martínez
ClinicalTrials.gov Identifier:
NCT00640198
First received: March 17, 2008
Last updated: March 20, 2008
Last verified: March 2008

March 17, 2008
March 20, 2008
March 2005
November 2007   (final data collection date for primary outcome measure)
Language function (overall aphasia severity). [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00640198 on ClinicalTrials.gov Archive Site
  • Depression [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Cognitive evaluation of language function [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in event-related potential [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Memantine and Intensive Speech-Language Therapy in Aphasia
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.
  • 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).
  • 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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Aphasia
  • Stroke
  • Drug: memantine
    Memantine was titrated in 5-mg weekly increments as recommended,from a starting dose of 5 mg/day to 20 mg/day. After the 3-week up-titration phase all patients received a fixed dose of either memantine (10 mg) or placebo twice daily without CIAT during the next 3 months (week 16). During the next 2 weeks (weeks 16-18), the drug treatment was combined with CIAT. This phase of combined treatment was followed by a 2-week period (weeks 18-20) where patients received memantine or placebo treatment alone and, finally, by a 4-week period of drug withdrawal (weeks 20-24)
    Other Name: Ebixa, Namenda
  • Behavioral: constraint-induced language therapy (CIAT)
    CIAT is an intensive form of language-action therapy for aphasia performed in a small group setting. In a therapeutic game context, participants had to request objects or cards from each other and understand requests made by others. Feedback of communicative success was regularly given, along with guidance, help and reinforcement. Gesturing replacing verbal language was discouraged although gestures accompanying speech were allowed. Difficulty levels were adjusted to the patients´ communicative abilities by choosing language materials and actions and reinforcement was administered taking into account each patient´s level of performance. Communication rules were introduced by shaping and modelling. Each patient received 30 hours of therapy.
    Other Name: Intensive language-action therapy
  • Drug: memantine
    Memantine was titrated in 5-mg weekly increments as recommended, from a starting dose of 5 mg/day to 20 mg/day. After the 3-week up-titration phase all patients received a fixed dose of either memantine (10 mg) or placebo twice daily without CIAT during the next 3 months (week 16). During the next 2 weeks (weeks 16-18), the drug treatment was combined with CIAT. This phase of combined treatment was followed by a 2-week period (weeks 18-20) where patients received memantine or placebo treatment alone and, finally, by a 4-week period of drug withdrawal (weeks 20-24).
    Other Name: Ebixa, Namenda
  • Drug: placebo
    Placebo
  • Active Comparator: Group 1 Memantine
    Patients included in this group will receive memantine alone followed by memantine combined with intensive speech-language therapy.
    Interventions:
    • Drug: memantine
    • Behavioral: constraint-induced language therapy (CIAT)
    • Drug: memantine
  • Placebo Comparator: Group 2
    Patients included in this group will receive placebo alone followed by memantine combined with intensive speech-language therapy.
    Interventions:
    • Behavioral: constraint-induced language therapy (CIAT)
    • Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
November 2007
November 2007   (final data collection date for primary outcome measure)

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)
Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00640198
M-10830, Gabinete Berthier y Martínez., Lundbeck, Spain, S.A.
No
Not Provided
Gabinete Berthier y Martínez
H. Lundbeck A/S
Principal Investigator: Marcelo L. Berthier, M.D., Ph.D Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES), University of Malaga
Gabinete Berthier y Martínez
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP