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

Study Overview

• Status: Completed
• Conditions: Aphasia
• Intervention / Treatment: Drug: levodopa and benserazide; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland
    • Neurorééducation, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 .
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
performance in denomination in the two word list will be compared	at the begining , at two weeks and at 5 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Study Director: Armin Schniider, Prof, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: July 16, 2009
• First Submitted That Met QC Criteria: July 16, 2009
• First Posted (Estimate): July 17, 2009

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: levodopa; treatment of anomia; patient with aphasia hospitalised at the "Service de neurorehabilitation" with presence of anomia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Levodopa; Benserazide
• Other Study ID Numbers: CER 05-159 (NAC 05.051)