Early Versus Delayed Treatment of Unilateral Neglect After Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University Ghent.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01341574
First received: April 18, 2011
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

'Unilateral neglect' is a disorder that occurs regularly after stroke. It is caused by right- as well as left-sided brain lesions, but more often by right-sided lesions. Patients with this disorder neglect the contralesional side of space and/or their body. Their body axis is often shifted ipsilesionally. A specific disorder that can appear in neglect patients is 'contraversive pushing': a postural deviation to the neglected side because the patient pushes himself away from the ipsi- to the contralesional side.

One of the most promising neglect interventions is prism adaptation (PA): inducing an optical shift of the visual field by means of prism glasses. This results in a modulation of brain areas involved in neglect and in an improvement of the neglect symptoms and postural deviation.

Research questions:

  1. Which period is best suited to maximize therapeutic effects? In this respect the effects of early and delayed PA will be compared, regarding neglect-, postural and cerebral measures.
  2. Which factors lead to a less favorable treatment outcome or to therapy resistance for PA?
  3. Will the impact of PA be larger if postural factors are taken into account in the prism therapy?

Condition Intervention
Spatial Neglect After Stroke
Procedure: Prism adaptation with optical shift of 10 degrees.
Procedure: Prism adaptation optical shift of 0 degrees.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Influence of Prism Adaptation on Spatial Neglect in the Early Versus Delayed Phase After Stroke: a Randomized, Placebo-controlled Trial

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • effect of prism adaptation [ Time Frame: Briefly after and 3 months after therapy cycle. ] [ Designated as safety issue: No ]

    The effect of Prism Adaptation (PA) will be evaluated regarding the degree of neglect, postural control and cerebral functioning, briefly after the therapy cycle and 3 months later. Briefly after the PA sessions and three months later, in patients in the early as well as the delayed phase after stroke:

    • early: PA starting within 4 weeks after stroke;
    • delayed: PA starting 2 months after stroke;
    • OR divided in an early and a delayed group according to the median.


Secondary Outcome Measures:
  • The degree of well-being. [ Time Frame: Briefly after and 3 months after therapy cycle. ] [ Designated as safety issue: No ]

    Questionnaires about emotional and functional status.

    Briefly after the Prism Adaptation (PA) sessions and 3 months later, in patients in the early as well as the delayed phase after stroke:

    • early: PA starting within 4 weeks after stroke;
    • delayed: PA starting 2 months after stroke;
    • OR divided in an early and a delayed group according to the median.


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early phase, experimental
Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the early phase after stroke.
Procedure: Prism adaptation with optical shift of 10 degrees.
Prism adaptation with optical shift of 10 degrees.
Experimental: Delayed phase, experimental
Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the delayed phase after stroke.
Procedure: Prism adaptation with optical shift of 10 degrees.
Prism adaptation with optical shift of 10 degrees.
Placebo Comparator: Early phase, placebo
Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the early phase after stroke.
Procedure: Prism adaptation optical shift of 0 degrees.
Prism adaptation with optical shift of 0 degrees.
Placebo Comparator: Delayed phase, placebo
Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the delayed phase after stroke.
Procedure: Prism adaptation optical shift of 0 degrees.
Prism adaptation with optical shift of 0 degrees.
Experimental: Delayed phase postural, experimental
Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the delayed phase after stroke. In this group, postural aspects are taken into account.
Procedure: Prism adaptation with optical shift of 10 degrees.
Prism adaptation with optical shift of 10 degrees.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female
  • > 17 years of age
  • stroke patients with clinical neglect, demonstrated by neglect tests

Exclusion Criteria:

  • severe ocular abnormalities
  • not being able to perform prism adaptation or neglect tests
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341574

Contacts
Contact: Nathalie Vaes, Ph.D. student Nathalie.Vaes@ugent.be
Contact: Guy Vingerhoets, Ph.D. Guy.Vingerhoets@ugent.be

Locations
Belgium
Rehabilitation Hospital "Hof ter Schelde" Recruiting
Antwerp, Belgium
Contact: Christophe Lafosse, Ph.D       Christophe.Lafosse@hofterschelde.be   
Principal Investigator: Christophe Lafosse, Ph.D.         
Ghent University Hospital, Center for Locomotor and Neurological Rehabilitation Recruiting
Ghent, Belgium
Contact: Kristine Oostra, M.D.       Kristine.Oostra@uzgent.be   
Principal Investigator: Kristine Oostra, M.D.         
Ghent University Hospital, Department of Neurology Recruiting
Ghent, Belgium
Contact: Dimitri Hemelsoet, M.D.       Dimitri.Hemelsoet@ugent.be   
Principal Investigator: Dimitri Hemelsoet, M.D.         
Sponsors and Collaborators
University Ghent
Fund for Scientific Research, Flanders, Belgium
Investigators
Principal Investigator: Guy Vingerhoets, Ph.D. , Professor University Ghent
  More Information

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01341574     History of Changes
Other Study ID Numbers: 2011/161, G.0906.10
Study First Received: April 18, 2011
Last Updated: April 13, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by University Ghent:
spatial neglect
stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Perceptual Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014