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Effect of Dopaminergic Medication on Recovery of Aphasia

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00941265
First received: July 16, 2009
Last updated: January 25, 2010
Last verified: July 2009

July 16, 2009
January 25, 2010
February 2007
December 2009   (final data collection date for primary outcome measure)
performance in denomination in the two word list will be compared [ Time Frame: at the begining , at two weeks and at 5 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00941265 on ClinicalTrials.gov Archive Site
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Effect of Dopaminergic Medication on Recovery of Aphasia
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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

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Aphasia
  • 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 .
  • 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.
  • levodopa 100 mg and benserazide 25 mg
    2 weeks with Daily CAT on list A+ levodopa and benserazide
    Intervention: Drug: levodopa and benserazide
  • placebo
    2 weeks with Daily CAT on list B + placebo.
    Intervention: Drug: placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
15
January 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient with aphasia hospitalised at the "Service of neurorehabilitation" with presence of anomia absence of comprehension deficits, absence of executive or apraxic dysfunctions that might impede the handling of keyboard or mouse, absence of stereotypies or perseverations dominating the aphasic symptoms.

Exclusion Criteria:

  • Patients who do not have their ability to judge or who suffer from Parkinson's syndrome requiring dopaminergic treatment will be excluded. Moreover, absolute medical contraindications for the medication will be respected: known hypersensitivity to one of the components, patients taking MAO inhibitors or sympathomimetics, severe hormonal, renal, hepatic, or cardiac affections, pregnancy or breastfeeding, women at reproductive age without reliable contraception, angle closure glaucoma, psychosis or severe neurosis, age < 25 years, malign melanoma, or planned anesthesia during the study period + 48 hours.
Both
25 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00941265
CER 05-159 (NAC 05.051)
Yes
Leemann / Dr, University Hospital , Geneva
University Hospital, Geneva
Not Provided
Study Director: Armin Schniider, Prof University Hospital, Geneva
University Hospital, Geneva
July 2009

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