Early Versus Delayed Treatment of Unilateral Neglect After Stroke

University Ghent

Status: Completed

Conditions: Spatial Neglect After Stroke

Treatments: Procedure: Prism adaptation with optical shift of 10 degrees.; Procedure: Prism adaptation optical shift of 0 degrees.

Study type: Interventional

Funder types: Other

Identifiers

NCT01341574

2011/161

G.0906.10 (Other Grant/Funding Number)

Details and patient eligibility

About

'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?

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 5 patient groups, including a placebo group

Early phase, experimental

Experimental group

Description:

Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the early phase after stroke.

Treatment:

Procedure: Prism adaptation with optical shift of 10 degrees.

Delayed phase, experimental

Experimental group

Description:

Neglect patients, randomized in the experimental group (Prism adaptation, optical shift of 10 degrees) in the delayed phase after stroke.

Treatment:

Procedure: Prism adaptation with optical shift of 10 degrees.

Early phase, placebo

Placebo Comparator group

Description:

Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the early phase after stroke.

Treatment:

Procedure: Prism adaptation optical shift of 0 degrees.

Delayed phase, placebo

Placebo Comparator group

Description:

Neglect patients, randomized in the placebo group (Prism adaptation, optical shift of 0 degrees) in the delayed phase after stroke.

Treatment:

Procedure: Prism adaptation optical shift of 0 degrees.

Delayed phase postural, experimental

Experimental group

Description:

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.

Treatment:

Procedure: Prism adaptation with optical shift of 10 degrees.