Spatial NeglectNCT02068664
An Assessment of the Prevalence of Spatial Neglect in Stroke Survivors With Aphasia
An observational study of Spatial Neglect and Aphasia, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this study is to determine if stroke survivors with aphasia have spatial neglect (Phase 1). If they are determined to have the condition Phase 2 will be offered: which is prism adaptation treatment. This is a pilot study that will be performed with 4-5 subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spatial Neglect, Aphasia, Stroke
- What is being tested?
- prism adaptation treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2016
- Phase
- Observational
- 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
Study population: Stroke survivors with aphasia and spatial neglect
Who may be able to join
- A stroke survivor with aphasia who is a member at the Adler Aphasia Center
Who cannot join
- Has a history of brain tumor, head injury with loss of consciousness, dementia, alzheimers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Assessment of the Prevalence of Spatial Neglect in Stroke Survivors With Aphasia With Option of Prism Adaptation Treatment (PAT) Protocol
The purpose of this study is to determine if stroke survivors with aphasia have spatial neglect (Phase 1). If they are determined to have the condition Phase 2 will be offered: which is prism adaptation treatment. This is a pilot study that will be performed with 4-5 subjects.
Read the detailed description
Spatial neglect is a disorder that may occur after a brain injury such as stroke. Spatial neglect may affect stroke recovery. One example of this heterogeneous condition: Individuals with spatial neglect often pay more attention to one side of what they are looking at, even though they have no difficulty seeing. The study investigators would like to screen stroke survivors with aphasia because they may also have spatial neglect (right neglect after left hemisphere stroke), which is said by the literature to occur in 25% of cases. If it is identified, a treatment approach will be offered, to attempt to remediate the condition using prism goggles, following a prism treatment protocol based on previous studies.
- Conditions
- Spatial Neglect, Aphasia, Stroke
- Being tested
- prism adaptation treatment
- Keywords
- spatial neglect, aphasia
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prism adaptation treatmentBehavioural
Prism goggles shift the image one sees toward the left (because the thicker portion of the glass lens is on the right). This will change the perception of where the image is in space, causing the person to adapt. The after-effects of the treatment is what is important. It has been shown to make it easier for people to move in the right space (if have right neglect) or improves ability to complete other functional tasks.
| Study group | Role | What they receive |
|---|---|---|
| Observational | prism adaptation treatment Receives: Behavioral: prism adaptation treatment |
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: 2 weeks
Secondary outcomes (3)
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
University of Alabama at Birmingham (UAB) Life Space assessment
a self graded assessment on community mobility and participation
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 posted21 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spatial NeglectStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Hreha, OT, Principal investigator, Kessler Foundation/Kessler Institute for RehabilitationA.M. Barrett, M.D., Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068664
- Sponsor's protocol ID
- R-802-13
- Status last verified
- Aug 2017
- First submitted
- 12 Feb 2014
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Prevalence of Spatial Neglect in Stroke Survivors With Aphasia With Option of Prism Adaptation Treatment (PAT) Protocol
- ClinicalTrials.gov ID
- NCT02068664
- Acronym / sponsor ID
- R-802-13
- Conditions
- Spatial Neglect, Aphasia, Stroke
- Keywords
- spatial neglect, aphasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Feb 2014 (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 study is to determine if stroke survivors with aphasia have spatial neglect (Phase 1). If they are determined to have the condition Phase 2 will be offered: which is prism adaptation treatment. This is a pilot study that will be performed with 4-5 subjects.
Detailed description
Spatial neglect is a disorder that may occur after a brain injury such as stroke. Spatial neglect may affect stroke recovery. One example of this heterogeneous condition: Individuals with spatial neglect often pay more attention to one side of what they are looking at, even though they have no difficulty seeing. The study investigators would like to screen stroke survivors with aphasia because they may also have spatial neglect (right neglect after left hemisphere stroke), which is said by the literature to occur in 25% of cases. If it is identified, a treatment approach will be offered, to attempt to remediate the condition using prism goggles, following a prism treatment protocol based on previous studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Behavioral: prism adaptation treatmentprism adaptation treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke survivors with aphasia and spatial neglect
Key inclusion criteria (1 listed)
- A stroke survivor with aphasia who is a member at the Adler Aphasia Center
Key exclusion criteria (1 listed)
- Has a history of brain tumor, head injury with loss of consciousness, dementia, alzheimers
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 treatmentPrism goggles shift the image one sees toward the left (because the thicker portion of the glass lens is on the right). This will change the perception of where the image is in space, causing the person to adapt. The after-effects of the treatment is what is important. It has been shown to make it easier for people to move in the right space (if have right neglect) or improves ability to complete other functional tasks. | Behavioural | Observational |
Primary outcome
Kessler Foundation Neglect Assessment Process
Time frame: 2 weeks
a performance based and behavioral measure for spatial neglect that utilizes and standardizes the administration of the Catherine Bergego Scale (CBS)
3 secondary outcomes
Behavior Inattention Test
Time frame: 2 weeks
Barthel Index
Time frame: 2 weeks
University of Alabama at Birmingham (UAB) Life Space assessment
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Kessler FoundationLink provided by the sponsor.
Related trials for Spatial Neglect
Recruiting
Immersive Virtual Reality Treatment for Unilateral Spatial Neglect
Stroke, Unilateral Spatial Neglect
Not yet recruiting
Dosing and Deployment Trial: A Home-based Optokinetic Treatment
Spatial Neglect
Recruiting
Strategy Training for Optimizing Attention for Individuals With Spatial Neglect
Stroke, Neglect, Hemispatial
Recruiting
Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation
Spatial Neglect After Right Brain Stroke
Not yet recruitingObservational study
Validation of Web-Based Star Cancellation and Line Bisection Tests in Hemiplegic Stroke
Stroke, Spatial Neglect
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.
Kimberly Hreha, OT principal investigator
Kessler Foundation/Kessler Institute for Rehabilitation
A.M. Barrett, M.D. 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?
An observational study of Spatial Neglect and Aphasia, 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 1 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: finished, as of the sponsor's last update on 21 Aug 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 2 weeks). 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 21 Aug 2017.