Feasibility and Effectiveness Study of Implementing Prism Adaptation as a Treatment for Spatial Neglect After Stroke

NCT02680171 | Completed

• 1 other identifier: TRICSpatialNeglect2016
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Spatial neglect is a common attention disorder after right hemisphere stroke and is associated with decreased independence and quality of life. Despite its high prevalence in the stroke population, there is currently no standard of care for the treatment of neglect. Prism adaptation (PA) is a promising rehabilitation technique, however incorporation into clinical care has been limited likely due to the lack of standardized procedures. The investigators have developed a computerized PA technique designed to better engage patients and assist clinicians. In this study the investigators aim to evaluate the feasibility and effectiveness of the computerized PA procedure in a typical health care setting, with the hypothesis that the PA procedure will improve patient's neglect symptoms.

Conditions

Sensory Neglect; Stroke

Keywords

Cognitive Rehabilitation; Prism Adaptation; Stroke; Spatial Neglect

Outcome Measures

Primary Outcomes (1)

• Change in Sunnybrook Neglect Assessment Procedure (SNAP)

  Test of neglect severity

  Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start)

Secondary Outcomes (9)

• Change in Johnny Shirt Visual Scanning Task

  Taken at baseline, after five intervention sessions are completed (approximately 1 week post-treatment start), and after the intervention (approximately two weeks post-treatment start)

• Change in Behavioural Inattention Test - Behaviour subtests (BIT-B)

  Taken at baseline and after the intervention (approximately two weeks post-treatment start)

• Change in Catherine Bergego Scale (CBS)

  Taken at baseline and after the intervention (approximately two weeks post-treatment start)

• Change in Halifax Neglect Severity Scale

  Taken after the intervention (approximately two weeks post-treatment start) and at follow-up (approximately 3 months post-discharge from the Nova Scotia Rehabilitation and Arthritis Centre)

• Change in Functional Independence Measure (FIM)

  Taken at baseline and at discharge up to 3 months

Study Arms (2)

Prism adaptation treatment

EXPERIMENTAL

Prism Goggles with ten-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care.

Behavioral: Prism Goggles

Sham prism adaptation treatment

SHAM COMPARATOR

Non-Shifting Goggles (sham) will be worn by patients in the control condition. These goggles do not shift the patients visual field.

Other: Non-Shifting Goggles

Interventions

Prism Goggles BEHAVIORAL

Patients in the experimental condition will wear prism goggles while completing a computerized aiming task. This prisms will shift the patients' vision 10 degrees rightward, causing a recalibration of visuo-motor information. Prism adaptation will be carried out over several days.

Prism adaptation treatment

Non-Shifting Goggles OTHER

Non-shifting goggles are worn instead of prism goggles, while completing the same computerized aiming task as those assigned to the prism adaptation.

Also known as: Control condition

Sham prism adaptation treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Experience mild to severe symptoms of neglect (as measured by the Sunnybrook Neglect Assessment Procedure and/or as determined based on clinical judgment of the treating team)
• Be willing to participate
• Be able to consent to participate
• Be medically stable
• Have normal or corrected to normal vision
• Be able to point to targets presented on a computer screen.

You may not qualify if:

• Other neurological disease (e.g., Multiple Sclerosis, Parkinsons disease)
• Dementia

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H3N5, Canada

Location

Related Publications (2)

• Champod AS, Taylor K, Eskes GA. Development of a new computerized prism adaptation procedure for visuo-spatial neglect. J Neurosci Methods. 2014 Sep 30;235:65-75. doi: 10.1016/j.jneumeth.2014.05.023. Epub 2014 Jun 19.

  PMID: 24952321 BACKGROUND

• Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.

  PMID: 34196963 DERIVED

MeSH Terms

Conditions

Perceptual Disorders; Stroke

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gail A Eskes, PhD

  Nova Scotia Health Authority; Dalhousie University

  PRINCIPAL INVESTIGATOR

• Richard Braha, PhD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

• Anne Sophie Champod, PhD

  Dalhousie University; Acadia University

  STUDY CHAIR

• Joy Boyce, BScOT

  Nova Scotia Health Authority

  STUDY CHAIR

• Myrna King, BScOT

  Nova Scotia Health Authority

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 11, 2016
• Study Start: February 6, 2018
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)