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
  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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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 .
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
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

Keywords provided by 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
Communication Disorders
Language Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Speech Disorders
Benserazide
Levodopa
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014