Spatial NeglectNCT00989430
Prism Adaptation Therapy for Spatial Neglect
A study testing Prism Adaptation Treatment in people with Spatial Neglect and Deficits in Attention Motor Control and Perception, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this research study with a randomized controlled design is to examine the effects of prism adaptation treatment on two visual-spatial recovery components. After a stroke, an "internal GPS", locating where objects or people lie in a particular area of space, may be impaired. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spatial Neglect, Deficits in Attention Motor Control and Perception
- What is being tested?
- Prism Adaptation Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2021
- 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
- The subject is 18 to 100 years of age, inclusive.
- The subject has had a stroke on the right side of the brain.
- The subject is able to give Informed consent.
- The subject has a spatial neglect (if known).
- The subject is able and willing to comply with the study protocol, including availability for all scheduled clinic visits.
Who cannot join
- The subject has or had a serious brain condition other than stroke.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
About this study
Official title: Prism Adaptation Therapy for Spatial Neglect: Theoretical and Practical Outcomes
The purpose of this research study with a randomized controlled design is to examine the effects of prism adaptation treatment on two visual-spatial recovery components. After a stroke, an "internal GPS", locating where objects or people lie in a particular area of space, may be impaired. Alternately, a stroke may impair precise visual-spatial hand and body aiming movements. The research team wishes to discover whether prism adaptation treatment (two weeks of daily 20-min sessions of goal-directed movement with prism goggles) affects visual-spatial where or aiming errors selectively after stroke.
This research represents one of the first attempts to apply what we know about the brain from neuroscience research, to modern clinical rehabilitation practices.
Read the detailed description
The purpose of this research study with a randomized controlled design is to examine the effects of prism adaptation treatment on two visual-spatial recovery components. After a stroke, an "internal GPS", locating where objects or people lie in a particular area of space, may be impaired. Alternately, a stroke may impair precise visual-spatial hand and body aiming movements. The research team wishes to discover whether prism adaptation treatment (two weeks of daily 20-min sessions of goal-directed movement with prism goggles) affects visual-spatial where or aiming errors selectively after stroke.
This research represents one of the first attempts to apply what we know about the brain from neuroscience research, to modern clinical rehabilitation practices.
- Being tested
- Prism Adaptation Treatment
- Keywords
- stroke, CVA, cerebrovascular accident, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prism Adaptation TreatmentBehavioural
Wearing prism goggles and performing visuomotor tasks during therapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| Prism Adaptation Treatment | Experimental | Two weeks of prism adaptation treatment followed by 4 weekly assessments and long-term follow-ups at the 3rd and 6th months. Receives: Behavioral: Prism Adaptation Treatment |
| Control: Standard Rehabilitation Care | No intervention | Participants will continue with their standard inpatient rehabilitation care. They will be assessed with cognitive and functional scales for tracking their recovery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kessler Foundation Neglect Assessment Process
a performance based and behavioral measure for spatial neglect that utilizes and standardizes the administration of the Catherine Bergego Scale (CBS)
Measured: 6 months
Secondary outcomes (2)
Behavior Inattention Test
Conventional subtest, a set of paper and pencil test for spatial neglect
Measured: 2 weeks
Barthel Index
A functional independence assessment of daily tasks
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startOct 2012
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, A. M. Barrett, MD, Kessler Foundation
- Investigators
- A. M. Barrett, MD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989430
- Sponsor's protocol ID
- AMBarrett3
- Other IDs
- Spatial Neglect
- Status last verified
- Feb 2021
- First submitted
- 2 Oct 2009
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34196963Boukrina O, Chen P, Budinoska T, Barrett AM. Exploratory examination of lexical and neuroanatomic correlates of neglect dyslexia. Neuropsychology. 2020 May;34(4):404-419. doi: 10.1037/neu0000619. Epub 2020 Jan 30.
PubMed 31999167Caulfield MD, Chen P, Barry MM, Barrett AM. Which perseverative behaviors are symptoms of spatial neglect? Brain Cogn. 2017 Apr;113:93-101. doi: 10.1016/j.bandc.2016.11.002. Epub 2017 Feb 3.
PubMed 28167411
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prism Adaptation Therapy for Spatial Neglect: Theoretical and Practical Outcomes
- ClinicalTrials.gov ID
- NCT00989430
- Acronym / sponsor ID
- AMBarrett3
- Keywords
- stroke, CVA, cerebrovascular accident, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Oct 2012
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 5 Oct 2009 (estimated)
- 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.
The purpose of this research study with a randomized controlled design is to examine the effects of prism adaptation treatment on two visual-spatial recovery components. After a stroke, an "internal GPS", locating where objects or people lie in a particular area of space, may be impaired. Alternately, a stroke may impair precise visual-spatial hand and body aiming movements. The research team wishes to discover whether prism adaptation treatment (two weeks of daily 20-min sessions of goal-directed movement with prism goggles) affects visual-spatial where or aiming errors selectively after stroke.
This research represents one of the first attempts to apply what we know about the brain from neuroscience research, to modern clinical rehabilitation practices.
Detailed description
The purpose of this research study with a randomized controlled design is to examine the effects of prism adaptation treatment on two visual-spatial recovery components. After a stroke, an "internal GPS", locating where objects or people lie in a particular area of space, may be impaired. Alternately, a stroke may impair precise visual-spatial hand and body aiming movements. The research team wishes to discover whether prism adaptation treatment (two weeks of daily 20-min sessions of goal-directed movement with prism goggles) affects visual-spatial where or aiming errors selectively after stroke.
This research represents one of the first attempts to apply what we know about the brain from neuroscience research, to modern clinical rehabilitation practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prism Adaptation Treatment | Experimental | Behavioral: Prism Adaptation TreatmentTwo weeks of prism adaptation treatment followed by 4 weekly assessments and long-term follow-ups at the 3rd and 6th months. |
| Control: Standard Rehabilitation Care | No intervention | –Participants will continue with their standard inpatient rehabilitation care. They will be assessed with cognitive and functional scales for tracking their recovery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject is 18 to 100 years of age, inclusive.
- The subject has had a stroke on the right side of the brain.
- The subject is able to give Informed consent.
- The subject has a spatial neglect (if known).
- The subject is able and willing to comply with the study protocol, including availability for all scheduled clinic visits.
Key exclusion criteria (1 listed)
- The subject has or had a serious brain condition other than stroke.
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 Adaptation TreatmentWearing prism goggles and performing visuomotor tasks during therapy sessions. | Behavioural | Prism Adaptation Treatment |
Primary outcome
Kessler Foundation Neglect Assessment Process
Time frame: 6 months
a performance based and behavioral measure for spatial neglect that utilizes and standardizes the administration of the Catherine Bergego Scale (CBS)
2 secondary outcomes
Behavior Inattention Test
Time frame: 2 weeks
Barthel Index
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 34196963Longley 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.
- Derived from this study: PubMed 31999167Boukrina O, Chen P, Budinoska T, Barrett AM. Exploratory examination of lexical and neuroanatomic correlates of neglect dyslexia. Neuropsychology. 2020 May;34(4):404-419. doi: 10.1037/neu0000619. Epub 2020 Jan 30.
- Derived from this study: PubMed 28167411Caulfield MD, Chen P, Barry MM, Barrett AM. Which perseverative behaviors are symptoms of spatial neglect? Brain Cogn. 2017 Apr;113:93-101. doi: 10.1016/j.bandc.2016.11.002. Epub 2017 Feb 3.
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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.
A. M. Barrett, MD principal investigator
Kessler Foundation
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 Adaptation Treatment in people with Spatial Neglect and Deficits in Attention Motor Control and Perception, run by Kessler Foundation at 1 site in United States.
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 5 inclusion and 1 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 17 Feb 2021. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kessler Foundation Neglect Assessment Process (time frame: 6 months). 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 NCT00989430, which also lists 3 linked publications.
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 17 Feb 2021; AzTrials last refreshed its copy on 27 Oct 2026.