Spatial NeglectNCT02080286
Transcranial Stimulation (tDCS) and Prism Adaptation in Spatial Neglect Rehabilitation
A study testing Prism Adaptation and Anodal tDCS in people with Spatial Neglect and Stroke, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The present study aims to compare the relative therapeutic efficacy of prism adaptation therapy combined with real versus sham tDCS. The investigators will test the hypothesis that the magnitude and duration of neglect improvement will be increased when prism therapy is combined with real tDCS compared to sham tDCS. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Spatial Neglect, Stroke, Cerebrovascular Disorders
- What is being tested?
- Prism Adaptation and Anodal tDCS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Dec 2019
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18-85
- At least one month post ischaemic or haemorrhagic stroke or brain damage to the right hemisphere
- Diagnosis of neglect confirmed by evidence of neglect on at least one of the tests in the battery of neglect tests administered during the Recruitment Interview
- Absolute contraindications to participation in any part of the study:
- Anyone who does not have adequate understanding of English, sufficient to give informed consent
Show all 22Show fewer
- Limited verbal communication in the form of dysphasia
- Any person who has a history of drug abuse as the data collected may be influenced by their condition
- Any person who has a history of dementia or any other psychiatric illness as the data collected may be influenced by their condition
- Absolute contraindications to participation in the tDCS part of the study:
- Anyone who has a previous personal history of epilepsy, seizures, febrile convulsions as a child or recurrent fainting fits will be excluded from the tDCS part of the study
- Any metallic implant in the neck, head, or eye that is situated within the path of the tDCS current, and anyone with any implanted electrical devices, would be excluded as there is a risk of heating with tDCS
- Pregnant women are excluded as a precaution as there are no data on the effect on maternal tDCS or MRI on the foetus
- Absolute contraindications to participation in the MRI part of the study:
- People who suffer from claustrophobia will be excluded from the MRI part of the study if they state they are unable to tolerate the scanner environment
- Anyone with a metal implant or implantable device that is found to be unsafe or unknown for MRI following investigations by named researchers and staff radiographers would be excluded.
- Pregnant women are excluded as a precaution as there are no data on the effect on maternal tDCS or MRI on the foetus
- Potential contraindications to participation in the tDCS part of the study:
- Participants on some prescription medications such as anti-depressants or pain medication may be excluded as they may be at an increased risk of seizure
- Individuals who have a family history of epilepsy or seizure may be excluded as this may increase the individual's personal risk of susceptibility to seizures
- Potential contraindications to participation in the MRI part of the study:
- An individual with a previous history of a surgical procedure may be excluded, depending on whether a metallic implant was used in their operation and whether the MRI-safety status of the implanted materials can be adequately assessed after requesting the medical/surgical notes (with patient consent) and/or post-surgical imaging and consulting with the staff radiographers who are legally responsible for determining participant safety in advance of any scanning.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Thomas Smejka contact
United Kingdom1 site, 1 recruiting
- Recruiting
FMRIB Centre, John Radcliffe Hospital, University of Oxford
Oxford, OX3 9DU
Jacinta O'Shea, PhD, +44 (0)1865 611455, jacinta.oshea@ndcn.ox.ac.uk
Susan Field, +44 (0)1865 611450
About this study
Official title: Boosting the Therapeutic Benefits of Prism Adaptation by Combining it With tDCS
The present study aims to compare the relative therapeutic efficacy of prism adaptation therapy combined with real versus sham tDCS. The investigators will test the hypothesis that the magnitude and duration of neglect improvement will be increased when prism therapy is combined with real tDCS compared to sham tDCS.
A second objective is to test whether individual differences in baseline clinical or brain imaging measures can predict: 1) neglect severity or 2) inter-individual differences in patients' therapeutic response.
A third goal is to use brain imaging to characterize the patterns of neural change induced by the intervention to identify brain structures that mediate therapeutic response.
Read the detailed description
'Neglect' is a common neurological syndrome that affects approximately 50% of right-hemisphere stroke patients. It is a complex multi-faceted syndrome, but its core defining feature is that patients lose the capacity to voluntarily control attention in the left half of space. Neglect has a significant debilitating effect on patients' functional independence and everyday life and indicates a poor prognosis for long-term functional recovery.
To date, there is no effective rehabilitation intervention available for routine clinical use. One of the most promising experimental strategies for neglect rehabilitation is prism adaptation, a form of motor training that induces short-lived improvements in a variety of cognitive domains. However, its major limitation is that the benefits are transient. The investigators aim to test the hypothesis that by combining prism therapy with transcranial direct current stimulation (tDCS), this will boost learning/memory processes, resulting in larger and longer-lasting therapeutic effects.
The investigators will conduct a randomized controlled clinical trial to test the efficacy of multi-session prism therapy combined with real versus sham tDCS for the rehabilitation of chronic post-stroke neglect. Baseline neuroimaging data will be used as predictor variables to explain inter-individual variation in therapeutic response. Contrasts between pre- and post-intervention imaging data will be performed to identify neural structures that mediate therapeutic effects.
- Being tested
- Prism Adaptation, Anodal tDCS, Sham tDCS
- Keywords
- spatial neglect, rehabilitation, brain stimulation, tDCS, prism adaptation
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Cerebral Infarction, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prism AdaptationBehavioural
All participants will undergo prism adaptation, a form of behavioural therapy involving reaching and pointing movements while wearing glasses that induce an optical shift.
Anodal tDCSDevice
Participants will receive 1mA anodal tDCS over the left primary motor cortex. The active (positive) electrode will be centered on the scalp overlying the primary motor cortex and the reference (negative) electrode will be placed over the contralateral supraorbital ridge.
The stimulation will last 20 minutes and run concurrent with the duration of the prism adaptation therapy.
Sham tDCSDevice
Participants will receive 1mA sham tDCS over the left primary motor cortex. The active (positive) electrode will be centered on the scalp overlying the primary motor cortex and the reference (negative) electrode will be placed over the contralateral supraorbital ridge.
The stimulation will last 20 minutes and run concurrent with the duration of the prism adaptation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Prism adaptation + anodal tDCS | Active comparator | Participants will receive 1 milliamp (mA) anodal tDCS over the left primary motor cortex concurrent with a 20-minute session of prism adaptation.
They will undergo 5 consecutive daily sessions. Receives: Behavioral: Prism Adaptation; Device: Anodal tDCS |
| Prism Adaptation + Sham tDCS | Placebo comparator | Participants will receive Sham tDCS over the left primary motor cortex concurrent with a 20-minute session of prism adaptation.
They will undergo 5 consecutive daily sessions. Receives: Behavioral: Prism Adaptation; Device: Sham tDCS |
| Prism adaptation + no tDCS | Placebo comparator | Participants will receive no tDCS at all but will undergo a 20-minute session of prism adaptation.
They will undergo 5 consecutive daily sessions. Receives: Behavioral: Prism Adaptation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural Inattention Test (BIT)
Change in score between the baseline session and the late post-intervention session.
Measured: Assessed at the recruitment interview (week 0) and at the exit interview (8 weeks after the intervention)
Neglect Test Battery
This battery features a range of computerized and paper-and-pencil tests of neglect (eg: cancellation, eye movement recordings, etc.). We are testing for the percentage change in performance on this battery from the baseline pre-intervention phase at each of the post-intervention timepoints.
Measured: Assessed at 2 separate pre-intervention baseline sessions at least 1 week apart. Re-assessed following the intervention at intervals of 1, 2, 4 and 8 weeks.
Secondary outcomes (1)
Changes in brain imaging data
We will test for changes in a range of MRI measures which we expect to be induced by the therapeutic intervention (measures of resting state and task functional MRI signal, grey and white matter, brain chemistry).
Measured: Change in a range of MRI measures between one baseline pre-intervention scan and the post-intervention scan (+ 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2018 (estimated)
- Study completionDec 2019 (estimated)
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 Spatial NeglectStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Jacinta O'Shea, Dr, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080286
- Sponsor's protocol ID
- 12/sc/0556
- Status last verified
- Oct 2017
- First submitted
- 4 Mar 2014
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PubMed 33175411
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting the Therapeutic Benefits of Prism Adaptation by Combining it With tDCS
- ClinicalTrials.gov ID
- NCT02080286
- Acronym / sponsor ID
- 12/sc/0556
- Keywords
- spatial neglect, rehabilitation, brain stimulation, tDCS, prism adaptation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Feb 2014
- Primary completion
- May 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Mar 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 present study aims to compare the relative therapeutic efficacy of prism adaptation therapy combined with real versus sham tDCS. The investigators will test the hypothesis that the magnitude and duration of neglect improvement will be increased when prism therapy is combined with real tDCS compared to sham tDCS.
A second objective is to test whether individual differences in baseline clinical or brain imaging measures can predict: 1) neglect severity or 2) inter-individual differences in patients' therapeutic response.
A third goal is to use brain imaging to characterize the patterns of neural change induced by the intervention to identify brain structures that mediate therapeutic response.
Detailed description
'Neglect' is a common neurological syndrome that affects approximately 50% of right-hemisphere stroke patients. It is a complex multi-faceted syndrome, but its core defining feature is that patients lose the capacity to voluntarily control attention in the left half of space. Neglect has a significant debilitating effect on patients' functional independence and everyday life and indicates a poor prognosis for long-term functional recovery.
To date, there is no effective rehabilitation intervention available for routine clinical use. One of the most promising experimental strategies for neglect rehabilitation is prism adaptation, a form of motor training that induces short-lived improvements in a variety of cognitive domains. However, its major limitation is that the benefits are transient. The investigators aim to test the hypothesis that by combining prism therapy with transcranial direct current stimulation (tDCS), this will boost learning/memory processes, resulting in larger and longer-lasting therapeutic effects.
The investigators will conduct a randomized controlled clinical trial to test the efficacy of multi-session prism therapy combined with real versus sham tDCS for the rehabilitation of chronic post-stroke neglect. Baseline neuroimaging data will be used as predictor variables to explain inter-individual variation in therapeutic response. Contrasts between pre- and post-intervention imaging data will be performed to identify neural structures that mediate therapeutic effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prism adaptation + anodal tDCS | Active comparator | Behavioral: Prism Adaptation, Device: Anodal tDCSParticipants will receive 1 milliamp (mA) anodal tDCS over the left primary motor cortex concurrent with a 20-minute session of prism adaptation. They will undergo 5 consecutive daily sessions. |
| Prism Adaptation + Sham tDCS | Placebo comparator | Behavioral: Prism Adaptation, Device: Sham tDCSParticipants will receive Sham tDCS over the left primary motor cortex concurrent with a 20-minute session of prism adaptation. They will undergo 5 consecutive daily sessions. |
| Prism adaptation + no tDCS | Placebo comparator | Behavioral: Prism AdaptationParticipants will receive no tDCS at all but will undergo a 20-minute session of prism adaptation. They will undergo 5 consecutive daily sessions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18-85
- At least one month post ischaemic or haemorrhagic stroke or brain damage to the right hemisphere
- Diagnosis of neglect confirmed by evidence of neglect on at least one of the tests in the battery of neglect tests administered during the Recruitment Interview
- Anyone who does not have adequate understanding of English, sufficient to give informed consent
Key exclusion criteria (0 listed)
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 AdaptationAll participants will undergo prism adaptation, a form of behavioural therapy involving reaching and pointing movements while wearing glasses that induce an optical shift. | Behavioural | Prism Adaptation + Sham tDCS, Prism adaptation + anodal tDCS, Prism adaptation + no tDCS |
| Anodal tDCSParticipants will receive 1mA anodal tDCS over the left primary motor cortex. The active (positive) electrode will be centered on the scalp overlying the primary motor cortex and the reference (negative) electrode will be placed over the contralateral supraorbital ridge. The stimulation will last 20 minutes and run concurrent with the duration of the prism adaptation therapy. | Device | Prism adaptation + anodal tDCS |
| Sham tDCSParticipants will receive 1mA sham tDCS over the left primary motor cortex. The active (positive) electrode will be centered on the scalp overlying the primary motor cortex and the reference (negative) electrode will be placed over the contralateral supraorbital ridge. The stimulation will last 20 minutes and run concurrent with the duration of the prism adaptation therapy. | Device | Prism Adaptation + Sham tDCS |
Primary outcome
Behavioural Inattention Test (BIT)
Time frame: Assessed at the recruitment interview (week 0) and at the exit interview (8 weeks after the intervention)
Change in score between the baseline session and the late post-intervention session.
Neglect Test Battery
Time frame: Assessed at 2 separate pre-intervention baseline sessions at least 1 week apart. Re-assessed following the intervention at intervals of 1, 2, 4 and 8 weeks.
This battery features a range of computerized and paper-and-pencil tests of neglect (eg: cancellation, eye movement recordings, etc.). We are testing for the percentage change in performance on this battery from the baseline pre-intervention phase at each of the post-intervention timepoints.
1 secondary outcome
Changes in brain imaging data
Time frame: Change in a range of MRI measures between one baseline pre-intervention scan and the post-intervention scan (+ 5 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Derived from this study: PubMed 33175411Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
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.
Thomas Smejka contact
Jacinta O'Shea, Dr principal investigator
University of Oxford
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 and Anodal tDCS in people with Spatial Neglect and Stroke, run by University of Oxford at 1 site in United Kingdom.
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 22 inclusion and 0 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 11 Oct 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 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. Some participants in this study may receive a placebo. 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?
Contact Jacinta O'Shea, PhD (+44 (0)1865 611455, jacinta.oshea@ndcn.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural Inattention Test (BIT) (time frame: Assessed at the recruitment interview (week 0) and at the exit interview (8 weeks after the intervention)). The study lists 2 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 NCT02080286, 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 Oct 2017.