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Status unknownNCT00196703Updated Sep 20, 2005

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

A Phase 4 interventional study of memantine and constraint-induced language therapy in Aphasia and Stroke, sponsored by Gabinete Berthier y Martínez. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2005-09-20.

Sponsored by Gabinete Berthier y Martínez · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2005), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 69 Years
Sex
All
01

Study 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).
Read the 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.
02

Conditions studied

  • Aphasia
  • Stroke

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Keywords

  • Aphasia
  • Memantine
  • Constraint-induced language therapy
  • Event-related potentials
03

In context

Aphasia

365 studies on the registry are indexed under Aphasia; 89 are open to participants now.

This study's enrollment of 30 is close to the median of 30 across 316 interventional studies indexed under Aphasia.

Browse Aphasia studies →

Lead sponsor

Gabinete Berthier y Martínez is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chronic aphasia of more than one year duration
  • Must be able to complete protocol

Exclusion criteria

Exclusion Criteria:

  • Dementia
  • Major psychiatric illness
  • Severe global aphasia (precludes participation in constraint-induced language therapy)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
30 participants

Interventions

  • Drugmemantine
  • Procedureconstraint-induced language therapy
06

What researchers measure

Primary outcomes

  1. Language function (overall aphasia severity).

  2. Communication

Secondary outcomes

  1. Depression

  2. Cognitive evaluation of language function

  3. Changes in event-related potential

07

Study locations

1 of 1 sites recruiting
  • Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES) University of Malaga
    Malaga, 29001, Spain
    • Marcelo L. Berthier, M.D., Ph.D · Contact · mberthier@terra.es · (34) 952 22 45 90
    • 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
    Recruiting
08

References and documents

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. doi: 10.1161/01.str.0000020094.08790.49. PubMed 12105362 ↗
  • 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. PubMed 15537523 ↗
  • 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. PubMed 12847569 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00196703
Lead sponsor
Gabinete Berthier y Martínez
Collaborators
H. Lundbeck A/S
First posted
Sep 20, 2005
Start date
Mar 2005
Completion
Sep 2005
Last update
Sep 20, 2005

Study contacts

Marcelo L. Berthier, M.D., Ph.D.
Contact
mberthier@terra.es
(34) 952 22 45 90
Marcelo L. Berthier, M.D., Ph.D
principal investigator · Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES), University of Malaga
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2005. You cannot join it, but the record below documents what was studied.

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