Hemispatial NeglectPhase 1NCT02695927
Rehabilitation Glasses for the Treatment of Hemispatial Neglect
A Phase 1 study testing Computer rehabilitation glasses in people with Hemispatial Neglect, run by Chun Lim at 1 site in United States.
Trial summary
This project is designed to test a lightweight, portable, computerized pair of glasses that will help reduce some of the cognitive deficits seen in patients who have suffered damage to their right cerebral hemisphere. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Hemispatial Neglect
- What is being tested?
- Computer rehabilitation glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to 26 Mar 2018
- Phase
- Phase 1
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of hemispatial neglect as defined by Behavioral Inattention Test score of 129 or worse (maximum score 146).
Who cannot join
- Presence of aphasia at time of testing,
- Recent seizures
- Major psychiatric illness
- Prior unrelated neurological disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
This project is designed to test a lightweight, portable, computerized pair of glasses that will help reduce some of the cognitive deficits seen in patients who have suffered damage to their right cerebral hemisphere.
Read the detailed description
Hemispatial neglect is the inability or failure to attend and respond to the left side of space. Patients suffering right cerebral hemispheric damage from stroke or traumatic brain injury frequently suffer neglect and will ignore all information located in the left side of space. Currently there is no effective rehabilitation technique to treat neglect and many of these patients have severe long-term disability. The goal of this project is to determine whether a prototypical pair of rehabilitation glasses can reduce the symptoms of hemispatial neglect.
- Conditions
- Hemispatial Neglect
- Being tested
- Computer rehabilitation glasses
- Medical subject headings
- Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer rehabilitation glassesDevice
| Study group | Role | What they receive |
|---|---|---|
| Chronic | Experimental | Crossover study on the benefits of computer rehabilitation glasses on chronic sufferers of hemispatial neglect Receives: Device: Computer rehabilitation glasses |
| Acute | Experimental | Randomized, controlled study on the benefits of computer rehabilitation glasses on acute sufferers of hemispatial neglect Receives: Device: Computer rehabilitation glasses |
| Optimization | Experimental | Study to identify optimal operating parameters of computer rehabilitation glasses Receives: Device: Computer rehabilitation glasses |
| Duration | Active comparator | Study to determine duration of effect of computer rehabilitation glasses Receives: Device: Computer rehabilitation glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of patient's hemispatial neglect scores
Behavioral Inattention Test
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startMar 2009
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
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 Hemispatial 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1/2 patients receive visual stimulation with rehabilitation glasses. 1/2 patients receive control stimulation with rehabilitation glasses.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chun Lim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chun Lim, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695927
- Sponsor's protocol ID
- 2009P000297
- Status last verified
- May 2018
- First submitted
- 7 Sep 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: IPD will be shared upon publication of the data. Other researchers can contact PI to request this data.
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 34196963
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Glasses for the Treatment of Hemispatial Neglect
- ClinicalTrials.gov ID
- NCT02695927
- Acronym / sponsor ID
- 2009P000297
- Conditions
- Hemispatial Neglect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Chun LimUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 1 Mar 2016 (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.
This project is designed to test a lightweight, portable, computerized pair of glasses that will help reduce some of the cognitive deficits seen in patients who have suffered damage to their right cerebral hemisphere.
Detailed description
Hemispatial neglect is the inability or failure to attend and respond to the left side of space. Patients suffering right cerebral hemispheric damage from stroke or traumatic brain injury frequently suffer neglect and will ignore all information located in the left side of space. Currently there is no effective rehabilitation technique to treat neglect and many of these patients have severe long-term disability. The goal of this project is to determine whether a prototypical pair of rehabilitation glasses can reduce the symptoms of hemispatial neglect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 1/2 patients receive visual stimulation with rehabilitation glasses. 1/2 patients receive control stimulation with rehabilitation glasses.
| Arm | Type | Receives |
|---|---|---|
| Chronic | Experimental | Device: Computer rehabilitation glassesCrossover study on the benefits of computer rehabilitation glasses on chronic sufferers of hemispatial neglect |
| Acute | Experimental | Device: Computer rehabilitation glassesRandomized, controlled study on the benefits of computer rehabilitation glasses on acute sufferers of hemispatial neglect |
| Optimization | Experimental | Device: Computer rehabilitation glassesStudy to identify optimal operating parameters of computer rehabilitation glasses |
| Duration | Active comparator | Device: Computer rehabilitation glassesStudy to determine duration of effect of computer rehabilitation glasses |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of hemispatial neglect as defined by Behavioral Inattention Test score of 129 or worse (maximum score 146).
Key exclusion criteria (4 listed)
- Presence of aphasia at time of testing,
- Recent seizures
- Major psychiatric illness
- Prior unrelated neurological disease
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 |
|---|---|---|
| Computer rehabilitation glasses | Device | Acute, Chronic, Duration, Optimization |
Primary outcome
Improvement of patient's hemispatial neglect scores
Time frame: 60 days
Behavioral Inattention Test
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 11 May 2018.
- 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.
- Individual participant dataSharing planned: Yes. IPD will be shared upon publication of the data. Other researchers can contact PI to request this data.
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Enrolling by invitation
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computer rehabilitation glasses in people with Hemispatial Neglect, run by Chun Lim 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 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: finished, as of the sponsor's last update on 11 May 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement of patient's hemispatial neglect scores (time frame: 60 days). 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 NCT02695927, 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 11 May 2018.