Effect of Dopaminergic Medication on Recovery of Aphasia

NCT00941265 | Completed DMC

• 1 other identifier: CER 05-159 (NAC 05.051)
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Aphasia

Keywords

treatment of anomia; levodopa; patient with aphasia hospitalised at the "Service de neurorehabilitation" with presence of anomia

Outcome Measures

Primary Outcomes (1)

• performance in denomination in the two word list will be compared

  at the begining , at two weeks and at 5 weeks

Study Arms (2)

levodopa 100 mg and benserazide 25 mg

OTHER

2 weeks with Daily CAT on list A+ levodopa and benserazide

Drug: levodopa and benserazide

placebo

OTHER

2 weeks with Daily CAT on list B + placebo.

Drug: placebo

Interventions

levodopa and benserazide DRUG

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 .

levodopa 100 mg and benserazide 25 mg

placebo DRUG

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.

placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Neurorééducation, University Hospital

Geneva, Switzerland

Location

MeSH Terms

Conditions

Aphasia

Interventions

benserazide, levodopa drug combination

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Armin Schniider, Prof

  University Hospital, Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 17, 2009
• Study Start: February 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

CH (1)