Effect of Dopaminergic Medication on Recovery of Aphasia
Primary Purpose
Aphasia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
levodopa and benserazide
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring treatment of anomia, levodopa, patient with aphasia hospitalised at the "Service de neurorehabilitation" with presence of anomia
Eligibility 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.
Sites / Locations
- Neurorééducation, University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
levodopa 100 mg and benserazide 25 mg
placebo
Arm Description
2 weeks with Daily CAT on list A+ levodopa and benserazide
2 weeks with Daily CAT on list B + placebo.
Outcomes
Primary Outcome Measures
performance in denomination in the two word list will be compared
Secondary Outcome Measures
Full Information
NCT ID
NCT00941265
First Posted
July 16, 2009
Last Updated
December 2, 2014
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT00941265
Brief Title
Effect of Dopaminergic Medication on Recovery of Aphasia
Official Title
Effect of Dopaminergic Medication on Recovery of Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
treatment of anomia, levodopa, patient with aphasia hospitalised at the "Service de neurorehabilitation" with presence of anomia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
levodopa 100 mg and benserazide 25 mg
Arm Type
Other
Arm Description
2 weeks with Daily CAT on list A+ levodopa and benserazide
Arm Title
placebo
Arm Type
Other
Arm Description
2 weeks with Daily CAT on list B + placebo.
Intervention Type
Drug
Intervention Name(s)
levodopa and benserazide
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
performance in denomination in the two word list will be compared
Time Frame
at the begining , at two weeks and at 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Schniider, Prof
Organizational Affiliation
University Hospital, Geneva
Official's Role
Study Director
Facility Information:
Facility Name
Neurorééducation, University Hospital
City
Geneva
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Effect of Dopaminergic Medication on Recovery of Aphasia
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