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| Sponsor: | University Hospital, Geneva |
|---|---|
| Information provided by: | University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT00941265 |
Purpose
The investigators have been offering computer assisted therapy of aphasia (CAT) as a complement to traditional treatments to aphasia patients of the "Service of Neurorehabilitation" for some years. The investigators have shown its efficacy in hospitalised patients with recently acquired aphasia.
In addition to studies stressing the importance of treatment intensity, several studies suggest that pharmacological treatment can also improve recovery after a cerebral lesion. The underlying idea is that the administration of medication influencing the system of neurotransmitters can play a role in functional recovery. Studies have assessed mainly substances acting on the dopaminergic (amphetamine and bromocriptine) and GABAergic system (piracetam).
The main objective of the present study concerns the evaluation of the effects of levodopa on recovery of anomia in patients with aphasia. In particular, the investigators use CAT to control intensity and quality of therapy and they will assess whether the administration of levodopa promotes recovery.
In each patient, two periods of anomia therapy with CAT, each performed with a different word list, will be compared. In addition to speech therapy, each period will be associated with the administration of either levodopa and benserazide (Madopar ®), or placebo. Evaluations at baseline and after each treatment period will be performed with the material and denomination battery
| Condition | Intervention |
|---|---|
|
Aphasia |
Drug: levodopa and benserazide Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Estimated Enrollment: | 15 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
levodopa 100 mg and benserazide 25 mg
2 weeks with Daily CAT on list A+ levodopa and benserazide
|
Drug: levodopa and benserazide
Daily Monday to Friday CAT with Daily Monday to Friday levodopa 100 mg with benserazide 25 mg , in the morning 1 h after breakfast, during 2 weeks .
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|
placebo
2 weeks with Daily CAT on list B + placebo.
|
Drug: placebo
Daily CAT Monday to Friday with daily placebo Monday to Friday , in the morning 1 h after breakfast, taken 5 out of 7 days during the 2 weeks of one of the two treatment periods.
|
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Leemann / Dr, University Hospital , Geneva |
| ClinicalTrials.gov Identifier: | NCT00941265 History of Changes |
| Other Study ID Numbers: | CER 05-159 (NAC 05.051) |
| Study First Received: | July 16, 2009 |
| Last Updated: | January 25, 2010 |
| Health Authority: | Switzerland: Swissmedic Switzerland: Ethikkommission |
|
treatment of anomia levodopa patient with aphasia hospitalised at the "Service de neurorehabilitation" with presence of anomia |
|
Aphasia Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Benserazide Levodopa |
Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs |
