Unilateral Spatial NeglectNEGLECTNCT03141996
Use of Vibration to Improve Visual/Spatial Neglect in Patients Affected by Stroke
A study testing Vibration to upper posterior neck muscles in people with Unilateral Spatial Neglect, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
This study will measure if five minutes of vibration to the upper back neck muscles, prior to standard of care treatment, will improve symptoms of spatial neglect and/or activities of daily living function for patients who have had a stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unilateral Spatial Neglect
- What is being tested?
- Vibration to upper posterior neck muscles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2017to 12 Apr 2018
- 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 years old or older
- demonstrated visual/spatial neglect, as demonstrated by NIH Stroke Scale (NIHSS) and deficits in assessing tactile extinction and visuospatial neglect done on admission.
Who cannot join
- severe pain or skin disease at the posterior neck
- severe atherosclerosis of carotid arteries by an ultrasonic evaluation
Trial locations and contacts
1 site in 1 country.
About this study
This study will measure if five minutes of vibration to the upper back neck muscles, prior to standard of care treatment, will improve symptoms of spatial neglect and/or activities of daily living function for patients who have had a stroke.
Read the detailed description
Spatial neglect is a common syndrome following stroke, most frequently of the right side of the brain. Such patients fail to be aware of objects or people to their left. This study is being done to learn if vibration treatment can improve visual/spatial neglect and activities of daily living in stroke patients better than current standard intervention.This treatment will be performed by occupational therapist practitioners prior to regular occupational therapy session using a vibration tool.
- Conditions
- Unilateral Spatial Neglect
- Being tested
- Vibration to upper posterior neck muscles, Standard of Care
- Keywords
- vibration, stroke, activities of daily living
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration to upper posterior neck musclesOther
Also called Magic Wand Massager
Vibration to upper posterior neck muscles using a vibrational tool.
Standard of CareOther
Standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Vibration to upper posterior neck muscles | Experimental | Treatment will be performed by occupational therapist practitioners prior to regular occupational therapy session using a vibration tool. Receives: Other: Vibration to upper posterior neck muscles |
| Standard of care | Active comparator | Regular occupational therapy session Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Inattention test
A short screening battery of tests to assess the presence and the extent of visual neglect on a sample of everyday problems faced by patients
Measured: Day 0
Secondary outcomes (8)
Behavioral Inattention test
A short screening battery of tests to assess the presence and the extent of visual neglect on a sample of everyday problems faced by patients
Measured: Day 30
Behavioral Inattention test
A short screening battery of tests to assess the presence and the extent of visual neglect on a sample of everyday problems faced by patients
Measured: Day 60
Catherine Bergego Scale (CBS)
a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.
Measured: Day 0
Catherine Bergego Scale (CBS)
a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.
Measured: Day 30
Catherine Bergego Scale (CBS)
a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.
Measured: Day 90
Activity Measure for Post-Acute Care (AM-PAC)
AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.
Measured: Day 0
Activity Measure for Post-Acute Care (AM-PAC)
AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.
Measured: Day 30
Activity Measure for Post-Acute Care (AM-PAC)
AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start16 Apr 2017
- Primary completion12 Apr 2018
- Study completion12 Apr 2018
Why it stopped: Poor enrollment
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florentina Mueller-Planitz, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141996
- Sponsor's protocol ID
- NEGLECT STUDY
- Acronym
- NEGLECT
- Status last verified
- Nov 2018
- First submitted
- 3 May 2017
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Vibration to Improve Visual/Spatial Neglect in Patients Affected by Stroke
- ClinicalTrials.gov ID
- NCT03141996
- Acronym / sponsor ID
- NEGLECT / NEGLECT STUDY
- Conditions
- Unilateral Spatial Neglect
- Keywords
- vibration, stroke, activities of daily living
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 16 Apr 2017 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 5 May 2017 (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 study will measure if five minutes of vibration to the upper back neck muscles, prior to standard of care treatment, will improve symptoms of spatial neglect and/or activities of daily living function for patients who have had a stroke.
Detailed description
Spatial neglect is a common syndrome following stroke, most frequently of the right side of the brain. Such patients fail to be aware of objects or people to their left. This study is being done to learn if vibration treatment can improve visual/spatial neglect and activities of daily living in stroke patients better than current standard intervention.This treatment will be performed by occupational therapist practitioners prior to regular occupational therapy session using a vibration tool.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration to upper posterior neck muscles | Experimental | Other: Vibration to upper posterior neck musclesTreatment will be performed by occupational therapist practitioners prior to regular occupational therapy session using a vibration tool. |
| Standard of care | Active comparator | Other: Standard of CareRegular occupational therapy session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old or older
- demonstrated visual/spatial neglect, as demonstrated by NIH Stroke Scale (NIHSS) and deficits in assessing tactile extinction and visuospatial neglect done on admission.
Key exclusion criteria (2 listed)
- severe pain or skin disease at the posterior neck
- severe atherosclerosis of carotid arteries by an ultrasonic evaluation
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 |
|---|---|---|
| Vibration to upper posterior neck musclesAlso: Magic Wand MassagerVibration to upper posterior neck muscles using a vibrational tool. | Other | Vibration to upper posterior neck muscles |
| Standard of CareStandard of care treatment | Other | Standard of care |
Primary outcome
Behavioral Inattention test
Time frame: Day 0
A short screening battery of tests to assess the presence and the extent of visual neglect on a sample of everyday problems faced by patients
8 secondary outcomes
Behavioral Inattention test
Time frame: Day 30
Behavioral Inattention test
Time frame: Day 60
Catherine Bergego Scale (CBS)
Time frame: Day 0
Catherine Bergego Scale (CBS)
Time frame: Day 30
Catherine Bergego Scale (CBS)
Time frame: Day 90
Activity Measure for Post-Acute Care (AM-PAC)
Time frame: Day 0
Activity Measure for Post-Acute Care (AM-PAC)
Time frame: Day 30
Activity Measure for Post-Acute Care (AM-PAC)
Time frame: Day 60
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 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: No
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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.
Florentina Mueller-Planitz principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration to upper posterior neck muscles in people with Unilateral Spatial Neglect, run by Intermountain Health Care, Inc. 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 2 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: stopped early, as of the sponsor's last update on 30 Nov 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.
Are results available for this study?
The study was stopped early (reason given: Poor enrollment). 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?
Behavioral Inattention test (time frame: Day 0). 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 NCT03141996, 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 30 Nov 2018.