Clinical trial NCT00663338: Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke
Official title: A Multi-centre Exploratory Study to Evaluate the Efficacy of the Dopamine Receptor Agonist Rotigotine in the Treatment of Hemispatial Neglect and Motor Deficits Following Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Right Hemisphere Stroke
Hemispatial Neglect
Motor Deficit
Keywords: Stroke
Hemispatial neglect
Unilateral neglect
Spatial neglect
Motor
Weakness
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2008-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effect of the drug rotigotine on the syndrome of hemispatial neglect and motor deficits following strokes affecting the right hemisphere of the brain.

Detailed description: Hemispatial neglect and motor deficits remain major problems following right-hemisphere stroke. This study aims to assess the effect of rotigotine on hemispatial neglect, its component cognitive deficits (including spatial working memory and sustained attention) and motor deficits following right-hemisphere stroke.

Eligibility criteria: Inclusion Criteria:

* Confirmed clinical diagnosis of right-hemisphere stroke.
* Able to give informed consent.
* Presence of left hemispatial neglect defined by a deficit in finding leftward targets on standard cancellation or visual search tests68-70. (A deficit on the line bisection test alone will not be sufficient for inclusion, as a previous study shows that there is no significant relationship between performance on this test and spatial working memory capacity37).
* Presence of motor deficits: all patients will have suffered from first-ever clinically defined stroke resulting in weakness of at least wrist and finger extensors, and hand interossei (to \</= 4+ on the Medical Research Council scale), at the time of recruitment.
* Age over 18 years.
* More than 9 days since stroke-onset (Note that on our protocol patches do not commence until a minimum of 6 days after the study begins. Thus patients will not receive drug / placebo until a minimum of 15 days post-stroke).
* Able and willing to use patches of drug/placebo and assessments at regular intervals as defined by the protocol.
* Able to comply with study requirements.
* If female and of child-bearing potential, subject has a negative serum pregnancy test within two days of enrollment.

Exclusion Criteria:

* Pre-existing neurological conditions that would confound cognitive and motor assessments, e.g. dementia, Parkinson's disease, Multiple Sclerosis.
* Presence of acute concomitant illness, e.g. infection, unstable angina, myocardial infarction or heart, respiratory, renal or liver failure which, based on clinical judgment, would be considered to confound interpretation of results.
* Systolic blood pressure less than 120 mmHg and / or diastolic less than 70 mmHg.
* Exposure to any other investigational drug within 30 days of enrollment in the study.
* History (obtained from patient and medical records) of clinically significant drug or alcohol abuse within 6 months prior to enrollment into the study.
* Pregnancy (because the effects of rotigotine on the fetus and mother in pregnancy are not known). If female and of child-bearing potential, a serum pregnancy test will be performed within two days of enrollment.
* Mothers who are breast feeding (because the effects of rotigotine on the newborn have not been established)

Primary outcomes:
measure: Performance on tests of hemispatial neglect and its cognitive components (spatial working memory and sustained attention).
timeFrame: 38 days
measure: Tests of motor control.
timeFrame: 38 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Homerton University Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: London
country: United Kingdom
facility: The National Hospital for Neurology & Neurosurgery
Study officials:
References: