Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196703
Status:
UNKNOWN
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Brief Title:
Memantine and Constraint-Induced Language Therapy in Chronic Poststroke AphasiaA Randomized Controlled Trial
Sponsor:
Gabinete Berthier y Martínez
Organization:
Gabinete Berthier y Martínez
Study Overview
Official Title:
A 24-Week Pilot Double-Blind Randomized Parallel Placebo-Controlled Study of Memantine and Constraint-Induced Language Therapy in Chronic Poststroke AphasiaCorrelation With Cognitive Evoked Potentials During Recovery
Status:
UNKNOWN
Status Verified Date:
2005-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Alzheimers 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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Lundbeck Spain SA | None | None | None |
| Gabinete Berthier y Martínez | None | None | None |