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Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke

Primary Purpose

Right Hemisphere Stroke, Hemispatial Neglect, Motor Deficit

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Rotigotine
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Right Hemisphere Stroke focused on measuring Stroke, Hemispatial neglect, Unilateral neglect, Spatial neglect, Motor, Weakness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Homerton University Hospital
  • Charing Cross Hospital
  • The National Hospital for Neurology & Neurosurgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

All patients receive placebo or rotigotine at some stage in the trial but the exact point is randomized.

Outcomes

Primary Outcome Measures

Performance on tests of hemispatial neglect and its cognitive components (spatial working memory and sustained attention).
Tests of motor control.

Secondary Outcome Measures

Full Information

First Posted
April 21, 2008
Last Updated
February 18, 2011
Sponsor
University College, London
Collaborators
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT00663338
Brief Title
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

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University College, London
Collaborators
Medical Research Council

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Hemisphere Stroke, Hemispatial Neglect, Motor Deficit
Keywords
Stroke, Hemispatial neglect, Unilateral neglect, Spatial neglect, Motor, Weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
All patients receive placebo or rotigotine at some stage in the trial but the exact point is randomized.
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Other Intervention Name(s)
Neupro
Intervention Description
Rotigotine 9.0mg patch (equivalent to 4mg/24hr transdermal absorption) once daily during the treatment phase.
Primary Outcome Measure Information:
Title
Performance on tests of hemispatial neglect and its cognitive components (spatial working memory and sustained attention).
Time Frame
38 days
Title
Tests of motor control.
Time Frame
38 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Homerton University Hospital
City
London
ZIP/Postal Code
E9 6SR
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W68RF
Country
United Kingdom
Facility Name
The National Hospital for Neurology & Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom

12. IPD Sharing Statement

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Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke

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