Hemispatial neglect and motor deficits following right-hemisphere stroke. MedDRA version: 9.1 Level: LLT Classification code 10042244 Term: Stroke
Conditions
Interventions
Trade Name: Neupro
Product Name: Rotigotine
Pharmaceutical Form: Transdermal patch
Pharmaceutical form of the placebo: Transdermal patch
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed clinical diagnosis of right-hemisphere stroke. 2. Able to give informed consent. 3. Presence of left hemispatial neglect defined by a deficit in finding leftward targets on standard cancellation or visual search tests. (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 capacity). 4. 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pre-existing neurological conditions that would confound cognitive and motor assessments, e.g. dementia, Parkinson’s disease, Multiple Sclerosis. 2. 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. 3. Systolic blood pressure less than 120 mmHg and / or diastolic less than 70 mmHg. 4. Exposure to any other investigational drug within 30 days of enrollment in the study. 5. History (obtained from patient and medical records) of clinically significant drug or alcohol abuse within 6 months prior to enrolment into the study. 6. Pregnancy (because the effects of rotigotine on the foetus 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 enrolment. 7. Mothers who are breast feeding (because the effects of rotigotine on the newborn have not been established)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of the drug rotigotine on the syndrome of hemispatial neglect and motor deficits following right-hemisphere stroke. ; Secondary Objective: If rotigotine reduces hemispatial neglect, does it do so by improving memory for spatial locations, improving the ability to sustain attention or ignore distracting information, or a combination of these processes? If motor deficits are improved by rotigotine, does the drug exert its beneficial effects by improving dexterity of the limbs? ;Primary end point(s): Completion of study protocol which lasts 5 weeks and 3 days for every participant. | — |
Countries
United Kingdom
Outcome results
None listed