Unilateral Spatial NeglectaPA-NEGLECTNCT06078111
Neglect Treatment by Prism Adaptation in the Acute Phase
A study testing Prism 10 + visuo-motor activities and Neutral Prism + visuo-motor activities in people with Unilateral Spatial Neglect, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
This project aims at unveiling the beneficial effects of prism adaptation as early rehabilitation technique to treat unilateral spatial neglect in the acute phase after a brain damage. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Unilateral Spatial Neglect
- What is being tested?
- Prism 10 + visuo-motor activities and Neutral Prism + visuo-motor activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2023to Feb 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First neurological event, affecting the right hemisphere or the left hemisphere (stroke, brain tumour post-surgery);
- Structural images of the brain lesion available (magnetic resonance or tomographic scans);
- Good Normal (or corrected) visual acuity;
- Presence of USN, as assessed by a standard neuropsychological evaluation.
Who cannot join
- Previous neurological disorder and/or current or previous psychiatric disease.
- Presence or suspicion of previous general cognitive deficits documented from the clinical dossier and/or suspicious of possible cognitive deficits ;
- Presence of difficulty in task's comprehension preventing its completion;
- Impossibility to sustain a research session of at least 30 minutes (e.g., attentional lability).
Trial locations and contacts
1 site in 1 country.
Jennifer Martin, PhD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Geneva
Geneva, Canton of Geneva, 1200
Roberta Ronchi, PhD, +41 (0)22 3728314, roberta.ronchi@hcuge.ch
About this study
This project aims at unveiling the beneficial effects of prism adaptation as early rehabilitation technique to treat unilateral spatial neglect in the acute phase after a brain damage. This syndrome, frequent and very invalidating for daily life activities after a brain damage, is a cognitive disorder of lack of attention towards a part of the space. Patients at a first event brain injury hospitalized into the Neurology and Neurosurgery Departments and affected by spatial neglect will undergo to a protocol of five consecutive rehabilitation treatments, being assigned to the experimental (prisms) or control groups (neutral prisms). The effectiveness of the treatment will be assessed with cognitive, functional and motor-related measures, as well as a follow up 3 months later. These results can have a strong impact on the long-term functional outcome of these patients.
- Conditions
- Unilateral Spatial Neglect
- Being tested
- Prism 10 + visuo-motor activities, Neutral Prism + visuo-motor activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prism 10 + visuo-motor activitiesBehavioural
Visuo-motor activities of exploration in the left and right space, adapting activities of daily living, while wearing prisms with 10 degrees of visual field deviation
Neutral Prism + visuo-motor activitiesBehavioural
Visuo-motor activities of exploration in the left and right space, adapting activities of daily living, while wearing prisms with no visual field deviation
| Study group | Role | What they receive |
|---|---|---|
| Prism 10 | Experimental | participants perform rehabilitation activities while wearing 10° visual field deviation prismatic goggles Receives: Behavioral: Prism 10 + visuo-motor activities |
| Neutral Prism | Active comparator | participants perform rehabilitation activities while wearing neutral (no deviation) visual field deviation prismatic goggles Receives: Behavioral: Neutral Prism + visuo-motor activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unilateral spatial neglect
Scores in the neuropsychological tasks administered just before and after the rehabilitation protocol: BEN battery, with the number of lateralized omissions in target cancellation, drawing and reading; bisection bias for the line bisection test
Measured: Day 0; Day 5; 12 weeks after the end of the protocol
Functional measures
Scores in the functional test testing USN administered just before and after the rehabilitation protocol: CBS scale, evaluating the impact of neglect in 10 daily living activities (range 0-30)
Measured: Day 0; Day 5; 12 weeks after the end of the protocol
Disability measures
Scale for assessing disability after stroke just before and after the rehabilitation protocol: FIM (range 18-126)
Measured: Day 0; Day 5; 12 weeks after the end of the protocol
Balance
Balance tests after stroke just before and after the rehabilitation protocol: PASS (range 0-36)
Measured: Day 0; Day 5; 12 weeks after the end of the protocol
Secondary outcomes (6)
Neuropsychological tests: Right vs. Left neglect
Comparison of the improvements in neuropsychological tests of patients with right vs. left unilateral spatial neglect on the following measures:
- BEN test: numbers of the lateralized omissions left-right in the target cancellation, drawing, reading; bisection bias in the bisection test The difference between patients with right vs. left spatial neglect following brain damaged will be computed by a difference in the outcome scores (omissions rates, bisection biases) and the incidence (percentage of patients) still defective vs. non-defective at each of these measures
Measured: Day 5; 12 weeks after the end of the protocol
Functional Measures: Right vs. Left neglect
Comparison of the improvements in the functional activities of daily living of patients with right vs. left unilateral spatial neglect on the following measures:
- CBS scale. The difference between patients with right vs. left spatial neglect following brain damaged will be computed by a difference in the outcome scores (total score of the functional scale) and the incidence (percentage of patients) still defective vs. non-defective at this measure
Measured: Day 5; 12 weeks after the end of the protocol
Disability Measures: Right vs. Left neglect
Comparison of the improvements of the disability scale of patients with right vs. left unilateral spatial neglect on the following measures:
- FIM The difference between patients with right vs. left spatial neglect following brain damaged will be computed by a difference in the outcome scores (total score of the scale) and the incidence (percentage of patients) still defective vs. non-defective at this measure
Measured: Day 5; 12 weeks after the end of the protocol
Balance: Right vs. Left neglect
Comparison of the improvements of balance of patients with right vs. left unilateral spatial neglect on the following measures:
- PASS The difference between patients with right vs. left spatial neglect following brain damaged will be computed by a difference in the outcome scores (total score of the scale) and the incidence (percentage of patients) still defective vs. non-defective at this measure
Measured: Day 5; 12 weeks after the end of the protocol
Functional Measures: Follow-up
Assessment of the functional benefit of the treatment procedure 3-months after the rehabilitation on the following measure:
- CBS: difference in the total score The difference between patients with spatial neglect who have been submitted to the prism 10 or the neutral prisms protocol will be compared in the follow up. The difference of the scores at the end of the protocol vs. in the follow-up will be performed for each group, and a differential score (prism 10 end of the protocol - prism 10 follow-up vs. neutral prisms end of the protocol - neutral prisms follow-up) will be also analysed to check for the maintenance of the effect. The differences will be computed using the total outcome scores and the incidence (percentage of patients) still defective vs. non-defective at this measure
Measured: 12 weeks after the end of the protocol
Balance: Follow-up
Assessment of the functional benefit of the treatment procedure 3-months after the rehabilitation on the following measure:
- PASS: difference in the total score The difference between patients with spatial neglect who have been submitted to the prism 10 or the neutral prisms protocol will be compared in the follow up. The difference of the scores at the end of the protocol vs. in the follow-up will be performed for each group, and a differential score (prism 10 end of the protocol - prism 10 follow-up vs. neutral prisms end of the protocol - neutral prisms follow-up) will be also analysed to check for the maintenance of the effect. The differences will be computed using the total outcome scores and the incidence (percentage of patients) still defective vs. non-defective at this measure
Measured: 12 weeks after the end of the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Nov 2023
- Primary completionSep 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Spatial NeglectStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Ronchi, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078111
- Sponsor's protocol ID
- aPA-NEGLECT
- Acronym
- aPA-NEGLECT
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neglect Treatment by Prism Adaptation in the Acute Phase
- ClinicalTrials.gov ID
- NCT06078111
- Acronym / sponsor ID
- aPA-NEGLECT / aPA-NEGLECT
- Conditions
- Unilateral Spatial Neglect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 11 Oct 2023 (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.
This project aims at unveiling the beneficial effects of prism adaptation as early rehabilitation technique to treat unilateral spatial neglect in the acute phase after a brain damage. This syndrome, frequent and very invalidating for daily life activities after a brain damage, is a cognitive disorder of lack of attention towards a part of the space. Patients at a first event brain injury hospitalized into the Neurology and Neurosurgery Departments and affected by spatial neglect will undergo to a protocol of five consecutive rehabilitation treatments, being assigned to the experimental (prisms) or control groups (neutral prisms). The effectiveness of the treatment will be assessed with cognitive, functional and motor-related measures, as well as a follow up 3 months later. These results can have a strong impact on the long-term functional outcome of these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prism 10 | Experimental | Behavioral: Prism 10 + visuo-motor activitiesparticipants perform rehabilitation activities while wearing 10° visual field deviation prismatic goggles |
| Neutral Prism | Active comparator | Behavioral: Neutral Prism + visuo-motor activitiesparticipants perform rehabilitation activities while wearing neutral (no deviation) visual field deviation prismatic goggles |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First neurological event, affecting the right hemisphere or the left hemisphere (stroke, brain tumour post-surgery);
- Structural images of the brain lesion available (magnetic resonance or tomographic scans);
- Good Normal (or corrected) visual acuity;
- Presence of USN, as assessed by a standard neuropsychological evaluation.
Key exclusion criteria (4 listed)
- Previous neurological disorder and/or current or previous psychiatric disease.
- Presence or suspicion of previous general cognitive deficits documented from the clinical dossier and/or suspicious of possible cognitive deficits ;
- Presence of difficulty in task's comprehension preventing its completion;
- Impossibility to sustain a research session of at least 30 minutes (e.g., attentional lability).
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 |
|---|---|---|
| Prism 10 + visuo-motor activitiesVisuo-motor activities of exploration in the left and right space, adapting activities of daily living, while wearing prisms with 10 degrees of visual field deviation | Behavioural | Prism 10 |
| Neutral Prism + visuo-motor activitiesVisuo-motor activities of exploration in the left and right space, adapting activities of daily living, while wearing prisms with no visual field deviation | Behavioural | Neutral Prism |
Primary outcome
Unilateral spatial neglect
Time frame: Day 0; Day 5; 12 weeks after the end of the protocol
Scores in the neuropsychological tasks administered just before and after the rehabilitation protocol: BEN battery, with the number of lateralized omissions in target cancellation, drawing and reading; bisection bias for the line bisection test
Functional measures
Time frame: Day 0; Day 5; 12 weeks after the end of the protocol
Scores in the functional test testing USN administered just before and after the rehabilitation protocol: CBS scale, evaluating the impact of neglect in 10 daily living activities (range 0-30)
Disability measures
Time frame: Day 0; Day 5; 12 weeks after the end of the protocol
Scale for assessing disability after stroke just before and after the rehabilitation protocol: FIM (range 18-126)
Balance
Time frame: Day 0; Day 5; 12 weeks after the end of the protocol
Balance tests after stroke just before and after the rehabilitation protocol: PASS (range 0-36)
6 secondary outcomes
Neuropsychological tests: Right vs. Left neglect
Time frame: Day 5; 12 weeks after the end of the protocol
Functional Measures: Right vs. Left neglect
Time frame: Day 5; 12 weeks after the end of the protocol
Disability Measures: Right vs. Left neglect
Time frame: Day 5; 12 weeks after the end of the protocol
Balance: Right vs. Left neglect
Time frame: Day 5; 12 weeks after the end of the protocol
Functional Measures: Follow-up
Time frame: 12 weeks after the end of the protocol
Balance: Follow-up
Time frame: 12 weeks after the end of the protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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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.
Jennifer Martin, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prism 10 + visuo-motor activities and Neutral Prism + visuo-motor activities in people with Unilateral Spatial Neglect, run by University of Geneva, Switzerland at 1 site in Switzerland.
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 4 inclusion and 4 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 27 Jun 2024. 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 Switzerland. 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. 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 Roberta Ronchi, PhD (+41 (0)22 3728314, roberta.ronchi@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unilateral spatial neglect (time frame: Day 0; Day 5; 12 weeks after the end of the protocol). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2024.