AphasiaNCT00941265
Effect of Dopaminergic Medication on Recovery of Aphasia
A study testing levodopa and benserazide in people with Aphasia, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aphasia
- What is being tested?
- levodopa and benserazide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2007to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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
- Being tested
- levodopa and benserazide, placebo
- Keywords
- treatment of anomia, levodopa, patient with aphasia hospitalised at the "Service de neurorehabilitation" with presence of anomia
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levodopa and benserazideDrug
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 .
placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| levodopa 100 mg and benserazide 25 mg | Other | 2 weeks with Daily CAT on list A+ levodopa and benserazide Receives: Drug: levodopa and benserazide |
| placebo | Other | 2 weeks with Daily CAT on list B + placebo. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance in denomination in the two word list will be compared
Measured: at the begining , at two weeks and at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startFeb 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leemann Beatrice, University Hospital, Geneva
- Investigators
- Armin Schniider, Prof, Study director, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941265
- Sponsor's protocol ID
- CER 05-159 (NAC 05.051)
- Status last verified
- Dec 2014
- First submitted
- 16 Jul 2009
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dopaminergic Medication on Recovery of Aphasia
- ClinicalTrials.gov ID
- NCT00941265
- Acronym / sponsor ID
- CER 05-159 (NAC 05.051)
- Conditions
- Aphasia
- Keywords
- treatment of anomia, levodopa, patient with aphasia hospitalised at the "Service de neurorehabilitation" with presence of anomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levodopa 100 mg and benserazide 25 mg | Other | Drug: levodopa and benserazide2 weeks with Daily CAT on list A+ levodopa and benserazide |
| placebo | Other | Drug: placebo2 weeks with Daily CAT on list B + placebo. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levodopa and benserazideDaily 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 . | Drug | levodopa 100 mg and benserazide 25 mg |
| placeboDaily 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. | Drug | placebo |
Primary outcome
performance in denomination in the two word list will be compared
Time frame: at the begining , at two weeks and at 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
Related trials for Aphasia
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Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
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Aphasia, ALS
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Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin Schniider, Prof study director
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing levodopa and benserazide in people with Aphasia, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performance in denomination in the two word list will be compared (time frame: at the begining , at two weeks and at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.