Memantine and Intensive Speech-Language Therapy in Aphasia

PHASE4CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

November 30, 2007

Study Completion Date

November 30, 2007

Conditions
AphasiaStroke
Interventions
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)

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.

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).

DRUG

placebo

Placebo

Trial Locations (1)

29001

Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES) University of Malaga, Málaga

All Listed Sponsors
collaborator

H. Lundbeck A/S

INDUSTRY

lead

Gabinete Berthier y Martínez

OTHER

NCT00640198 - Memantine and Intensive Speech-Language Therapy in Aphasia | Biotech Hunter | Biotech Hunter