Optokinetic Stimulation for Hemineglect

Application of Optokinetic Stimulation in the Treatment of Hemineglect

Hemineglect is a sequel to stroke, which appears more frequently when the injury occurs in the right cerebral hemisphere. Hemineglect refers to those patients who do not pay attention to their left side, presenting movement disorders that do not allow them to participate spontaneously in their activities of daily life.

There are different methodologies for the treatment of hemineglect. Among them, we find optokinetic stimulation (OKS), which consists of creating an illusory movement to the left to center the patient's frame of reference and thus, make them pay more attention to their left side. In recent years, the effect that this therapy has on motor movement disorders has begun to be explored, although the parameters for its correct application still seem to be unclear.

For this reason, our aim is to describe the effect that the OKS has on balance, posture, spatial representation and conscience, and movement disorders in hemineglect. Patients with hemineglect will undergo OKS to see its influence on the recovery of this sequel of stroke.

Study Overview

• Status: Recruiting
• Conditions: Perceptual Disorders; Unilateral Spatial Neglect
• Intervention / Treatment: Other: Placebo; Other: Optokinetic stimulation

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rocío Llamas-Ramos, Doctor; Phone Number: +34 657 854 188; Email: rociollamas@usal.es
• Study Contact Backup: Name: Fátima Pérez-Robledo, Doctor; Phone Number: +34 619 885 479; Email: fatima_pr@usal.es

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Recruiting
    • Universidad de Salamanca
    • Contact: Ana M Martín-Nogueras

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 year old or older
• Diagnosis of right stroke
• Diagnosis of left heminegligence

Exclusion Criteria:

• No cooperation and comunication problems
• Uncontrolled epileptic seizures or migraines

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	Other: Optokinetic stimulation; Participants are placed in a standing position, with support products, if necessary, and virtual reality glasses will be placed where the visual stimuli will be projected. The study will be carried out for 10 weeks with a frequency of two weekly sessions. During them, the participants will receive stimulation with OKS. Stimulation will be performed at 1 cm/second, the vertical black bars will move to the left. The bars change color and the participants will be asked to detect the changes that will occur in the stimulus.
Placebo Comparator: Control Group	Other: Placebo; Participants are placed in a standing position, with support products, if necessary, and virtual reality glasses will be placed where the visual stimuli will be projected. In this group, stimulation consists of a video with static vertical bars that change their colour at a randon intervals, in the same way that in the intervention group. The difference between groups is that in control group, bars are not in movement, preventing from generating optokinetic stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posture	To analyze static posture, a pressure platform will be used. It will be measured before and after the application of each experimental situation	60 minutes
Stability	To analyze static balance, a Carbon 5 Flex® pressure platform will be used. It will be measured before and after the application of each experimental situation	60 minutes
Fluff Test	It is a tool specifically designed to assess body representation in patients with hemineglect, through a body examination with closed eyes, and the removal of stickers located on both sides of the body. The percentage of stickers removed from each part of the body is assessed. It will be measured before and after the application of each experimental situation	60 minutes
Bisection of the line	It is one of the most used tools in the assessment of hemineglect. It consists of marking the middle of a line and evaluating how much deviation to the right occurs. The distance in centimeters to the center of the line is calculated. It will be measured before and after the application of each experimental situation	60 minutes
Fugl Meyer Assessment Scale	This scale assess upper limb, lower limb, balance, sensibility, range of motion and pain in patients with stroke.	60 minutes
Fullerton Advance Balance Test	This scale assess balance and postural control. It has a total punctuation of 40 points. People who are under 25 points have risk of fall.	60 minutes
Diller's cancelation test	This scale assess USN by crossing letters H included with distractors. The number of letters crossed are calculated.	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex	The sex of the participants is recorded at the start of the study	1 minute
Date of birth	The participant's date of birth is collected in order to calculate his age in years	1 minute
Date of injury	The date of the injury is registered in order to calculate the time of evolution with the disease	1 minute
Type of injury	Description of injury to analyse if it has some effect during intervention	1 minute
Admission time	Date of involvement in study	1 minute
National Institutes of Health Stroke Scale	is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.	10 minutes

Collaborators and Investigators

• Sponsor: University of Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Estimated): December 28, 2023
• Study Completion (Estimated): December 28, 2023

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Perceptual Disorders; Unilateral spatial neglect; Optokinetic stimulation; Photic stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders
• Other Study ID Numbers: NEUROUSAL02/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: The anonymized database (CSR) will be available from the publication of the results for 10 years in the repository of the University of Salamanca GREDOS. The study protocol, the SAP and the ICF will be published in advance.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No