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Effect of Dopaminergic Medication on Recovery of Aphasia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00941265
First Posted: July 17, 2009
Last Update Posted: December 3, 2014
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.
Information provided by (Responsible Party):
Leemann Beatrice, University Hospital, Geneva
  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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Dopaminergic Medication on Recovery of Aphasia

Resource links provided by NLM:


Further study details as provided by Leemann Beatrice, University Hospital, Geneva:

Primary Outcome Measures:
  • performance in denomination in the two word list will be compared [ Time Frame: at the begining , at two weeks and at 5 weeks ]

Enrollment: 12
Study Start Date: February 2007
Study Completion Date: August 2009
Primary Completion Date: August 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 .
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

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941265


Locations
Switzerland
Neurorééducation, University Hospital
Geneva, Switzerland
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Study Director: Armin Schniider, Prof University Hospital, Geneva
  More Information

Responsible Party: Leemann Beatrice, Dr., University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00941265     History of Changes
Other Study ID Numbers: CER 05-159 (NAC 05.051)
First Submitted: July 16, 2009
First Posted: July 17, 2009
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Leemann Beatrice, University Hospital, Geneva:
treatment of anomia
levodopa
patient with aphasia hospitalised at the "Service de neurorehabilitation" with presence of anomia

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Levodopa
Benserazide
Dopamine
Dopamine Agents
Dopamine Agonists
Antiparkinson Agents
Anti-Dyskinesia Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Protective Agents
Enzyme Inhibitors