Pusher SyndromeNCT03831594
Combining Physical Therapy With Vestibular Stimulation to Improve Postural Stability in Pusher's Syndrome
A study testing Galvanic Vestibular Stimulation and Standard Physiotherapy in people with Pusher Syndrome, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The study is evaluating the effect of combining Galvanic Vestibular Stimulation (GVS) with standard Physiotherapy treatment in patients admitted to a neurological rehabilitation unit with Pusher syndrome (PS). Patients will be randomised to receive standard Physiotherapy treatment or standard treatment with GVS. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pusher Syndrome
- What is being tested?
- Galvanic Vestibular Stimulation and Standard Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2018to 20 Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Pusher Inclusion Criteria:
- Identified hemiparetic neglect - identified PS from a stroke or acquired brain injury (using the Scale of Contraversive Pushing and The Burke Lateropulsion Scale)
- Consenting to participate in the trial
Pusher Exclusion Criteria:
- Severe cognitive impairment
- Receptive aphasia
- Medical co-morbidities
- Opthalamic impairment
- Vestibular impairment
- Peripheral neuropathy
- Also any contraindications to GVS including:
- Brain metallic implants
- Pacemakers
- Recent brain surgery
- Skull defect
- Preceding epileptic seizures
- Sensitive skin behind the ears.
Healthy volunteers inclusion criteria:
- 40 years old minimum age
- Consent to taking part in the trial
Healthy volunteers exclusion criteria:
- Vestibular impairment
- History of medical/psychiatric/neurological disorders
- Currently taking any psychoactive medication
- Drunk more than 3 units of alcohol in the past 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
The study is evaluating the effect of combining Galvanic Vestibular Stimulation (GVS) with standard Physiotherapy treatment in patients admitted to a neurological rehabilitation unit with Pusher syndrome (PS). Patients will be randomised to receive standard Physiotherapy treatment or standard treatment with GVS.
Perceived verticality data will also be collected and analysed on age-matched controls. This data will be used to compare these results with the patients with PS.
The investigators hypothesis that GVS and standard Physiotherapy treatment will lead to a greater improvement in functional ability and awareness of perceived verticality compared to standard Physiotherapy alone.
Read the detailed description
Pusher syndrome (PS) can be described as disordered balance and orientation which causes patients to perceive they are in an upright position when in fact they are positioned towards their affected side. These patients use their unaffected limbs to 'push' themselves away from their unaffected side in an attempt to correct their perceived postural alignment. PS is a common disorder and can affect 16% of stroke patients.
Patients with PS have shown to take longer to improve in rehabilitation than non-PS patients and tend to stay in hospital for longer.
Galvanic Vestibular Stimulation (GVS) involves passing a small electrical current behind the ear to stimulate the vestibular system to in-turn cause the head and body to move.
- Conditions
- Pusher Syndrome
- Being tested
- Galvanic Vestibular Stimulation, Standard Physiotherapy
- Keywords
- stroke, galvanic vestibular stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galvanic Vestibular StimulationDevice
Electrical current (under 1.5mA) applied to the mastoid processes to stimulate the balance organs in the inner ear
Standard PhysiotherapyOther
Also called Standard Physical Therapy
45 minutes of standard physiotherapy treating impairments and functional problems
| Study group | Role | What they receive |
|---|---|---|
| Standard Physiotherapy and Galvanic Vestibular Stimulation | Experimental | Standard physiotherapy concurrently with Galvanic Vestibular Stimulation for 45 minutes a day for two weeks (five days per week) Receives: Device: Galvanic Vestibular Stimulation; Other: Standard Physiotherapy |
| Standard Physiotherapy | Active comparator | Standard Physiotherapy for 45 minutes a day for two weeks (five days per week) Receives: Other: Standard Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale of Contraversive Pushing
This is made up of 3 components: 1.The symmetry of spontaneous body posture (rated with 0, 0.25, 0.75, or 1 point. 1 = severe tilt, 0 = no tilt), 2. The use of non-paretic extremities (0, 0.5, or 1 point. 1 = performed spontaneously at rest), 3. The resistance to passive correction of the tilted posture (0 or 1 point. 1 = resistance occurs). For a diagnosis of Pusher Syndrome all 3 components need to be present.
Measured: Change from baseline, end of week 1 and end of week 2
The Burke Lateropulsion Scale
Test of pushing. The score for each component is rated on a scale from 0 to 3 (0 to 4 for standing) and the score is based on the severity of resistance or the tilt angle when the patient begins to resist the passive movement. The score for diagnosis of Pusher behaviour is ≥2 points
Measured: Change from baseline, end of week 1 and end of week 2
Catherine Bergago Scale
The Catherine Bergego Scale is a standardized checklist (10 everyday tasks) to detect presence and degree of neglect during observation of everyday life situations. The scale also provides a measure of neglect self-awareness (anosognosia).4 point rating scale indicating severity of neglect (0 = no neglect, 3 = severe neglect).
Measured: Change from baseline, end of week 1 and end of week 2
Mesulam's symbol cancellation test
Mesulam's symbol cancellation test provides a measure of neglect, organisational process, and attention.
Measured: Change from baseline, end of week 1 and end of week 2
Berg Balance Scale
14-item scale designed to measure balance of the older adult in a clinical setting. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score the LOWEST performance. Total Score = 56
Measured: Change from baseline, end of week 1 and end of week 2
Functional Impairment Measure
18-item of physical, psychological and social function.The tool is used to assess a patient's level of disability as well as change in patient status in response to rehabilitation or medical intervention. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.
Measured: Change from baseline, end of week 1 and end of week 2
Secondary outcomes (3)
Subjective Visual Vertical
Test of perceived visual vertical alignment
Measured: Change from baseline, end of week 1 and end of week 2
Subjective Postural Vertical
Test of perceived postural vertical alignment
Measured: Change from baseline, end of week 1 and end of week 2
Subjective haptic vertical
Test of perceived haptic vertical alignment
Measured: Change from baseline, end of week 1 and end of week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Nov 2018
- Primary completion18 Jan 2021
- Study completion20 Jan 2021
Why it stopped: We were unable to recruit any suitable patients to this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pusher SyndromeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Homerton University Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Diego Kaski, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831594
- Sponsor's protocol ID
- 222784
- Status last verified
- Nov 2023
- First submitted
- 31 Jan 2019
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baccini M, Paci M, Nannetti L, Biricolti C, Rinaldi LA. Scale for contraversive pushing: cutoff scores for diagnosing "pusher behavior" and construct validity. Phys Ther. 2008 Aug;88(8):947-55. doi: 10.2522/ptj.20070179. Epub 2008 Jul 10.
PubMed 18617579P. Azouvi (1996) Functional Consequences and Awareness of Unilateral Neglect: Study of an Evaluation Scale, Neuropsychological Rehabilitation, 6:2, 133-150, DOI: 10.1080/713755501
Maggie J. Bailey, M. Jane Riddoch & Peter Crome (2004) Test-retest stability of three tests for unilateral visual neglect in patients with stroke: Star Cancellation, Line Bisection, and the Baking Tray Task, Neuropsychological Rehabilitation, 14:4, 403-419, DOI: 10.1080/09602010343000282
Barra J, Marquer A, Joassin R, Reymond C, Metge L, Chauvineau V, Perennou D. Humans use internal models to construct and update a sense of verticality. Brain. 2010 Dec;133(Pt 12):3552-63. doi: 10.1093/brain/awq311. Epub 2010 Nov 19.
PubMed 21097492Day BL, Severac Cauquil A, Bartolomei L, Pastor MA, Lyon IN. Human body-segment tilts induced by galvanic stimulation: a vestibularly driven balance protection mechanism. J Physiol. 1997 May 1;500 ( Pt 3)(Pt 3):661-72. doi: 10.1113/jphysiol.1997.sp022051.
PubMed 9161984Fitzpatrick RC, Wardman DL, Taylor JL. Effects of galvanic vestibular stimulation during human walking. J Physiol. 1999 Jun 15;517 ( Pt 3)(Pt 3):931-9. doi: 10.1111/j.1469-7793.1999.0931s.x.
PubMed 10358131Karnath HO, Johannsen L, Broetz D, Ferber S, Dichgans J. Prognosis of contraversive pushing. J Neurol. 2002 Sep;249(9):1250-3. doi: 10.1007/s00415-002-0824-z.
PubMed 12242549Karnath HO, Broetz D. Understanding and treating "pusher syndrome". Phys Ther. 2003 Dec;83(12):1119-25.
PubMed 14640870Karnath HO. Pusher syndrome--a frequent but little-known disturbance of body orientation perception. J Neurol. 2007 Apr;254(4):415-24. doi: 10.1007/s00415-006-0341-6. Epub 2007 Mar 25.
PubMed 17385082Nakamura J, Kita Y, Yuda T, Ikuno K, Okada Y, Shomoto K. Effects of galvanic vestibular stimulation combined with physical therapy on pusher behavior in stroke patients: a case series. NeuroRehabilitation. 2014;35(1):31-7. doi: 10.3233/NRE-141094.
PubMed 24990006Parton A, Malhotra P, Husain M. Hemispatial neglect. J Neurol Neurosurg Psychiatry. 2004 Jan;75(1):13-21.
PubMed 14707298Perennou DA, Mazibrada G, Chauvineau V, Greenwood R, Rothwell J, Gresty MA, Bronstein AM. Lateropulsion, pushing and verticality perception in hemisphere stroke: a causal relationship? Brain. 2008 Sep;131(Pt 9):2401-13. doi: 10.1093/brain/awn170. Epub 2008 Aug 4.
PubMed 18678565Utz KS, Korluss K, Schmidt L, Rosenthal A, Oppenlander K, Keller I, Kerkhoff G. Minor adverse effects of galvanic vestibular stimulation in persons with stroke and healthy individuals. Brain Inj. 2011;25(11):1058-69. doi: 10.3109/02699052.2011.607789. Epub 2011 Aug 31.
PubMed 21879800
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Physical Therapy With Vestibular Stimulation to Improve Postural Stability in Pusher's Syndrome
- ClinicalTrials.gov ID
- NCT03831594
- Acronym / sponsor ID
- 222784
- Conditions
- Pusher Syndrome
- Keywords
- stroke, galvanic vestibular stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were unable to recruit any suitable patients to this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Homerton University Hospital NHS Foundation Trust
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 6 Feb 2019 (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.
The study is evaluating the effect of combining Galvanic Vestibular Stimulation (GVS) with standard Physiotherapy treatment in patients admitted to a neurological rehabilitation unit with Pusher syndrome (PS). Patients will be randomised to receive standard Physiotherapy treatment or standard treatment with GVS.
Perceived verticality data will also be collected and analysed on age-matched controls. This data will be used to compare these results with the patients with PS.
The investigators hypothesis that GVS and standard Physiotherapy treatment will lead to a greater improvement in functional ability and awareness of perceived verticality compared to standard Physiotherapy alone.
Detailed description
Pusher syndrome (PS) can be described as disordered balance and orientation which causes patients to perceive they are in an upright position when in fact they are positioned towards their affected side. These patients use their unaffected limbs to 'push' themselves away from their unaffected side in an attempt to correct their perceived postural alignment. PS is a common disorder and can affect 16% of stroke patients.
Patients with PS have shown to take longer to improve in rehabilitation than non-PS patients and tend to stay in hospital for longer.
Galvanic Vestibular Stimulation (GVS) involves passing a small electrical current behind the ear to stimulate the vestibular system to in-turn cause the head and body to move.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Physiotherapy and Galvanic Vestibular Stimulation | Experimental | Device: Galvanic Vestibular Stimulation, Other: Standard PhysiotherapyStandard physiotherapy concurrently with Galvanic Vestibular Stimulation for 45 minutes a day for two weeks (five days per week) |
| Standard Physiotherapy | Active comparator | Other: Standard PhysiotherapyStandard Physiotherapy for 45 minutes a day for two weeks (five days per week) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Galvanic Vestibular StimulationElectrical current (under 1.5mA) applied to the mastoid processes to stimulate the balance organs in the inner ear | Device | Standard Physiotherapy and Galvanic Vestibular Stimulation |
| Standard PhysiotherapyAlso: Standard Physical Therapy45 minutes of standard physiotherapy treating impairments and functional problems | Other | Standard Physiotherapy, Standard Physiotherapy and Galvanic Vestibular Stimulation |
Primary outcome
Scale of Contraversive Pushing
Time frame: Change from baseline, end of week 1 and end of week 2
This is made up of 3 components: 1.The symmetry of spontaneous body posture (rated with 0, 0.25, 0.75, or 1 point. 1 = severe tilt, 0 = no tilt), 2. The use of non-paretic extremities (0, 0.5, or 1 point. 1 = performed spontaneously at rest), 3. The resistance to passive correction of the tilted posture (0 or 1 point. 1 = resistance occurs). For a diagnosis of Pusher Syndrome all 3 components need to be present.
The Burke Lateropulsion Scale
Time frame: Change from baseline, end of week 1 and end of week 2
Test of pushing. The score for each component is rated on a scale from 0 to 3 (0 to 4 for standing) and the score is based on the severity of resistance or the tilt angle when the patient begins to resist the passive movement. The score for diagnosis of Pusher behaviour is ≥2 points
Catherine Bergago Scale
Time frame: Change from baseline, end of week 1 and end of week 2
The Catherine Bergego Scale is a standardized checklist (10 everyday tasks) to detect presence and degree of neglect during observation of everyday life situations. The scale also provides a measure of neglect self-awareness (anosognosia).4 point rating scale indicating severity of neglect (0 = no neglect, 3 = severe neglect).
Mesulam's symbol cancellation test
Time frame: Change from baseline, end of week 1 and end of week 2
Mesulam's symbol cancellation test provides a measure of neglect, organisational process, and attention.
Berg Balance Scale
Time frame: Change from baseline, end of week 1 and end of week 2
14-item scale designed to measure balance of the older adult in a clinical setting. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score the LOWEST performance. Total Score = 56
Functional Impairment Measure
Time frame: Change from baseline, end of week 1 and end of week 2
18-item of physical, psychological and social function.The tool is used to assess a patient's level of disability as well as change in patient status in response to rehabilitation or medical intervention. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.
3 secondary outcomes
Subjective Visual Vertical
Time frame: Change from baseline, end of week 1 and end of week 2
Subjective Postural Vertical
Time frame: Change from baseline, end of week 1 and end of week 2
Subjective haptic vertical
Time frame: Change from baseline, end of week 1 and end of week 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Background: PubMed 18617579Baccini M, Paci M, Nannetti L, Biricolti C, Rinaldi LA. Scale for contraversive pushing: cutoff scores for diagnosing "pusher behavior" and construct validity. Phys Ther. 2008 Aug;88(8):947-55. doi: 10.2522/ptj.20070179. Epub 2008 Jul 10.
- BackgroundP. Azouvi (1996) Functional Consequences and Awareness of Unilateral Neglect: Study of an Evaluation Scale, Neuropsychological Rehabilitation, 6:2, 133-150, DOI: 10.1080/713755501
- BackgroundMaggie J. Bailey, M. Jane Riddoch & Peter Crome (2004) Test-retest stability of three tests for unilateral visual neglect in patients with stroke: Star Cancellation, Line Bisection, and the Baking Tray Task, Neuropsychological Rehabilitation, 14:4, 403-419, DOI: 10.1080/09602010343000282
- Background: PubMed 21097492Barra J, Marquer A, Joassin R, Reymond C, Metge L, Chauvineau V, Perennou D. Humans use internal models to construct and update a sense of verticality. Brain. 2010 Dec;133(Pt 12):3552-63. doi: 10.1093/brain/awq311. Epub 2010 Nov 19.
- Background: PubMed 9161984Day BL, Severac Cauquil A, Bartolomei L, Pastor MA, Lyon IN. Human body-segment tilts induced by galvanic stimulation: a vestibularly driven balance protection mechanism. J Physiol. 1997 May 1;500 ( Pt 3)(Pt 3):661-72. doi: 10.1113/jphysiol.1997.sp022051.
- Background: PubMed 10358131Fitzpatrick RC, Wardman DL, Taylor JL. Effects of galvanic vestibular stimulation during human walking. J Physiol. 1999 Jun 15;517 ( Pt 3)(Pt 3):931-9. doi: 10.1111/j.1469-7793.1999.0931s.x.
- Background: PubMed 12242549Karnath HO, Johannsen L, Broetz D, Ferber S, Dichgans J. Prognosis of contraversive pushing. J Neurol. 2002 Sep;249(9):1250-3. doi: 10.1007/s00415-002-0824-z.
- Background: PubMed 14640870Karnath HO, Broetz D. Understanding and treating "pusher syndrome". Phys Ther. 2003 Dec;83(12):1119-25.
- Background: PubMed 17385082Karnath HO. Pusher syndrome--a frequent but little-known disturbance of body orientation perception. J Neurol. 2007 Apr;254(4):415-24. doi: 10.1007/s00415-006-0341-6. Epub 2007 Mar 25.
- Background: PubMed 24990006Nakamura J, Kita Y, Yuda T, Ikuno K, Okada Y, Shomoto K. Effects of galvanic vestibular stimulation combined with physical therapy on pusher behavior in stroke patients: a case series. NeuroRehabilitation. 2014;35(1):31-7. doi: 10.3233/NRE-141094.
- Background: PubMed 14707298Parton A, Malhotra P, Husain M. Hemispatial neglect. J Neurol Neurosurg Psychiatry. 2004 Jan;75(1):13-21.
- Background: PubMed 18678565Perennou DA, Mazibrada G, Chauvineau V, Greenwood R, Rothwell J, Gresty MA, Bronstein AM. Lateropulsion, pushing and verticality perception in hemisphere stroke: a causal relationship? Brain. 2008 Sep;131(Pt 9):2401-13. doi: 10.1093/brain/awn170. Epub 2008 Aug 4.
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.
Diego Kaski, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galvanic Vestibular Stimulation and Standard Physiotherapy in people with Pusher Syndrome, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2023. 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 Kingdom. 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 withdrawn before enrolling participants, so there are no results.
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?
Scale of Contraversive Pushing (time frame: Change from baseline, end of week 1 and end of week 2). The study lists 6 primary outcomes in all. 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 NCT03831594, which also lists 13 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 8 Nov 2023.