Perceptual DisordersNCT04663646
Optokinetic Stimulation for Hemineglect
A study testing Optokinetic stimulation in people with Perceptual Disorders and Unilateral Spatial Neglect, run by University of Salamanca at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perceptual Disorders, Unilateral Spatial Neglect
- What is being tested?
- Optokinetic stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2023to 28 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 year old or older
- Diagnosis of right stroke
- Diagnosis of left heminegligence
Who cannot join
- No cooperation and comunication problems
- Uncontrolled epileptic seizures or migraines
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad de Salamanca
Salamanca, 37007
Ana M Martín-Nogueras
About this study
Official title: 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.
- Conditions
- Perceptual Disorders, Unilateral Spatial Neglect
- Being tested
- Optokinetic stimulation, Placebo
- Keywords
- Perceptual Disorders, Unilateral spatial neglect, Optokinetic stimulation, Photic stimulation
- Medical subject headings
- Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optokinetic stimulationOther
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Other: Optokinetic stimulation |
| Control Group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posture
To analyze static posture, a pressure platform will be used. It will be measured before and after the application of each experimental situation
Measured: 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
Measured: 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
Measured: 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
Measured: 60 minutes
Fugl Meyer Assessment Scale
This scale assess upper limb, lower limb, balance, sensibility, range of motion and pain in patients with stroke.
Measured: 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.
Measured: 60 minutes
Diller's cancelation test
This scale assess USN by crossing letters H included with distractors. The number of letters crossed are calculated.
Measured: 60 minutes
Secondary outcomes (6)
Sex
The sex of the participants is recorded at the start of the study
Measured: 1 minute
Date of birth
The participant's date of birth is collected in order to calculate his age in years
Measured: 1 minute
Date of injury
The date of the injury is registered in order to calculate the time of evolution with the disease
Measured: 1 minute
Type of injury
Description of injury to analyse if it has some effect during intervention
Measured: 1 minute
Admission time
Date of involvement in study
Measured: 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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start10 Jan 2023
- Primary completion28 Dec 2023 (estimated)
- Study completion28 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perceptual DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial in which an intervention group will undergo optokinetic stimulation with virtual reality glasses, and the control group will receive placebo sessions.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pérez-Robledo, Fátima, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663646
- Sponsor's protocol ID
- NEUROUSAL02/2020
- Status last verified
- Jul 2023
- First submitted
- 4 Dec 2020
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Perez-Robledo F, Sanchez Gonzalez JL, Bermejo-Gil BM, Llamas-Ramos R, Martin-Nogueras AM. Optokinetic stimulation effects in the management of unilateral spatial neglect in patients with chronic stroke: study protocol for a randomised controlled trial. BMJ Open. 2023 Jul 30;13(7):e070601. doi: 10.1136/bmjopen-2022-070601.
PubMed 37518082
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Optokinetic Stimulation in the Treatment of Hemineglect
- ClinicalTrials.gov ID
- NCT04663646
- Acronym / sponsor ID
- NEUROUSAL02/2020
- Conditions
- Perceptual Disorders, Unilateral Spatial Neglect
- Keywords
- Perceptual Disorders, Unilateral spatial neglect, Optokinetic stimulation, Photic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 28 Dec 2023 (estimated)
- Study completion
- 28 Dec 2023 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized clinical trial in which an intervention group will undergo optokinetic stimulation with virtual reality glasses, and the control group will receive placebo sessions.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Optokinetic stimulation |
| Control Group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 year old or older
- Diagnosis of right stroke
- Diagnosis of left heminegligence
Key exclusion criteria (2 listed)
- No cooperation and comunication problems
- Uncontrolled epileptic seizures or migraines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optokinetic stimulationParticipants 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. | Other | Intervention Group |
| PlaceboParticipants 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. | Other | Control Group |
Primary outcome
Posture
Time frame: 60 minutes
To analyze static posture, a pressure platform will be used. It will be measured before and after the application of each experimental situation
Stability
Time frame: 60 minutes
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
Fluff Test
Time frame: 60 minutes
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
Bisection of the line
Time frame: 60 minutes
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
Fugl Meyer Assessment Scale
Time frame: 60 minutes
This scale assess upper limb, lower limb, balance, sensibility, range of motion and pain in patients with stroke.
Fullerton Advance Balance Test
Time frame: 60 minutes
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.
Diller's cancelation test
Time frame: 60 minutes
This scale assess USN by crossing letters H included with distractors. The number of letters crossed are calculated.
6 secondary outcomes
Sex
Time frame: 1 minute
Date of birth
Time frame: 1 minute
Date of injury
Time frame: 1 minute
Type of injury
Time frame: 1 minute
Admission time
Time frame: 1 minute
National Institutes of Health Stroke Scale
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Derived from this study: PubMed 37518082Perez-Robledo F, Sanchez Gonzalez JL, Bermejo-Gil BM, Llamas-Ramos R, Martin-Nogueras AM. Optokinetic stimulation effects in the management of unilateral spatial neglect in patients with chronic stroke: study protocol for a randomised controlled trial. BMJ Open. 2023 Jul 30;13(7):e070601. doi: 10.1136/bmjopen-2022-070601.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optokinetic stimulation in people with Perceptual Disorders and Unilateral Spatial Neglect, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fátima Pérez-Robledo, Doctor (+34 619 885 479, fatima_pr@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posture (time frame: 60 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04663646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.