Effect of Dopaminergic Medication on Recovery of Aphasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00941265
Recruitment Status : Completed
First Posted : July 17, 2009
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Leemann Beatrice, University Hospital, Geneva

July 16, 2009
July 17, 2009
December 3, 2014
February 2007
August 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 ]
Same as current
Complete list of historical versions of study NCT00941265 on Archive Site
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Effect of Dopaminergic Medication on Recovery of Aphasia
Effect of Dopaminergic Medication on Recovery of Aphasia

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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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • 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 Identifier (NCT Number) in Medline.
August 2009
August 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.
Sexes Eligible for Study: All
25 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
CER 05-159 (NAC 05.051)
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Leemann Beatrice, University Hospital, Geneva
University Hospital, Geneva
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Study Director: Armin Schniider, Prof University Hospital, Geneva
University Hospital, Geneva
December 2014

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