StrokeRTNIBSNCT02401724
NonInvasive Brain Stimulation in Stroke Patients
A study testing Transcranial direct current stimulation and Action Training in people with Stroke, run by NHS Greater Glasgow and Clyde.
Trial summary
After a stroke affecting the right side of the brain, many patients are affected by "spatial neglect": the damage to the brain causes them to ignore the left side of their surroundings. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial direct current stimulation and Action Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jun 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke affecting the right hemisphere, confirmed by CT or MRI.
- Persistent neglect for one month after ictus (confirmed by BIT).
- Prestroke functional independence (modified Rankin Scale score 0-2).
- Between 18-90 years of age
Who cannot join
- Patients younger than 18.
- Patients who do not understand verbal or written English (ie.need of translaters)
- bilateral infarcts (Confirmed by CT, MRI)
- Dementia (MOCA, Score <26).
- Neurological Disease (eg. Parkinson's Disease, epilepsy, MS)
- Significant morbidity (eg cancer, severe cardiac failure) likely to affect participation.
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- Alcohol excess (more than 50/40 units a week for men/women respectively).
- Patients who fall under the exclusion criteria for TDCS which includes patients suffering from a stroke related seizure :
- History of epilepsy, medications or psychoactive drugs that can lower seizure threshold [imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel dust), ketamine, gammahydroxybutyrate (GHB), alcohol, theophylline]. Withdrawal from alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate. Patients who are pregnant or have suffered from a stroke-related seizure.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomised Trial of Non-Invasive Brain Stimulation (NIBS) in Stroke Survivors
After a stroke affecting the right side of the brain, many patients are affected by "spatial neglect": the damage to the brain causes them to ignore the left side of their surroundings. At its most extreme they may be unaware that they have a left side, or believe that it is moving normally when it is in fact paralysed. In milder cases, people may be unable to recognise touch on the left side if their right side is also being touched, or objects in their left visual field if something is visible to their right. Neglect alters peoples' quality of life profoundly, often renders them more dependent on others to undertake basic activities of daily living, and makes effective rehabilitation much more difficult.
The limited success of current treatment approaches indicates gaps in understanding of the underlying mechanisms of neglect and its recovery. Recent data suggest that the problems in responding to the left side are a result of an imbalance of activity in those parts of the brain responsible for deciding which side to pay attention to. It might therefore be possible to help people with neglect by "rebalancing" the brain either by increasing activity in the damaged side, or alternatively by reducing activity in the undamaged side. In this pilot study, the investigators will test whether they can help by doing the second of these things.
Read more
The investigators propose to conduct a pilot clinical trial to explore whether using electric currents to temporarily modify the activity of specific areas of the intact side of the brain, influences recovery from neglect, when used either alone, or in combination with a training method that has previously appeared promising as a treatment. Brain activity will be modified using a technique called "transcranial direct current stimulation (tDCS)", in which small electric currents are applied to the scalp with a wire covered in damp cotton pads. This will be done over the specific parts of the brain that are responsible for focusing attention to one side.
The investigators will compare the clinical outcomes of four interventions (1: behavioural, 2: tDCS, 3: a combination of both and 4: control).
The investigators hope that these studies will advance their understanding of what treatments may help people with neglect, and how they might work.
- Conditions
- Stroke
- Being tested
- Transcranial direct current stimulation, Action Training
- Keywords
- Hemispatial neglect, Transcranial direct current stimulation, Rehabilitation
- Medical subject headings
- Stroke, Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationOther
Also called tDCS
Action TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| Action Training | Active comparator | Training exercise which involves patients lifting up rods of different sizes and shifting their grip if this is too far to one side Receives: Other: Action Training |
| tDCS | Experimental | A constant 1mA current will be applied to the left (undamaged) side of the scalp with an electrode covered with a damp cotton pad (25 cm2). The current will be applied for 15 minutes per day, with a total of 10 sessions over 3 weeks. Receives: Other: Transcranial direct current stimulation |
| Action Training + tDCs | Experimental | This will involve the same procedure as in action training only but with tDCS applied for 15 minutes during the rodlifting. Receives: Other: Transcranial direct current stimulation; Other: Action Training |
| Control training | Placebo comparator | For the control training, patients will be asked to simply reach for the right hand side of each rod with their right (unaffected) hand and lift it |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Behavioural Inattention Test (BIT)
Measured: 6 months post intervention
Secondary outcomes (6)
Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
Measured: baseline
Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
Measured: 3 weeks
Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
Measured: 6 months
Retention Numbers
Measured: baseline
Retention Numbers
Measured: 3 weeks
Retention Numbers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401724
- Sponsor's protocol ID
- GN13NE562
- Acronym
- RTNIBS
- Status last verified
- Mar 2015
- First submitted
- 10 Mar 2015
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- 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 34196963Elsner 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 33175411Learmonth G, Benwell CSY, Marker G, Dascalu D, Checketts M, Santosh C, Barber M, Walters M, Muir KW, Harvey M. Non-invasive brain stimulation in Stroke patients (NIBS): A prospective randomized open blinded end-point (PROBE) feasibility trial using transcranial direct current stimulation (tDCS) in post-stroke hemispatial neglect. Neuropsychol Rehabil. 2021 Sep;31(8):1163-1189. doi: 10.1080/09602011.2020.1767161. Epub 2020 Jun 5.
PubMed 32498606
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of Non-Invasive Brain Stimulation (NIBS) in Stroke Survivors
- ClinicalTrials.gov ID
- NCT02401724
- Acronym / sponsor ID
- RTNIBS / GN13NE562
- Conditions
- Stroke
- Keywords
- Hemispatial neglect, Transcranial direct current stimulation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- Mar 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 30 Mar 2015 (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.
After a stroke affecting the right side of the brain, many patients are affected by "spatial neglect": the damage to the brain causes them to ignore the left side of their surroundings. At its most extreme they may be unaware that they have a left side, or believe that it is moving normally when it is in fact paralysed. In milder cases, people may be unable to recognise touch on the left side if their right side is also being touched, or objects in their left visual field if something is visible to their right. Neglect alters peoples' quality of life profoundly, often renders them more dependent on others to undertake basic activities of daily living, and makes effective rehabilitation much more difficult.
The limited success of current treatment approaches indicates gaps in understanding of the underlying mechanisms of neglect and its recovery. Recent data suggest that the problems in responding to the left side are a result of an imbalance of activity in those parts of the brain responsible for deciding which side to pay attention to. It might therefore be possible to help people with neglect by "rebalancing" the brain either by increasing activity in the damaged side, or alternatively by reducing activity in the undamaged side. In this pilot study, the investigators will test whether they can help by doing the second of these things.
The investigators propose to conduct a pilot clinical trial to explore whether using electric currents to temporarily modify the activity of specific areas of the intact side of the brain, influences recovery from neglect, when used either alone, or in combination with a training method that has previously appeared promising as a treatment. Brain activity will be modified using a technique called "transcranial direct current stimulation (tDCS)", in which small electric currents are applied to the scalp with a wire covered in damp cotton pads. This will be done over the specific parts of the brain that are responsible for focusing attention to one side.
The investigators will compare the clinical outcomes of four interventions (1: behavioural, 2: tDCS, 3: a combination of both and 4: control).
The investigators hope that these studies will advance their understanding of what treatments may help people with neglect, and how they might work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Action Training | Active comparator | Other: Action TrainingTraining exercise which involves patients lifting up rods of different sizes and shifting their grip if this is too far to one side |
| tDCS | Experimental | Other: Transcranial direct current stimulationA constant 1mA current will be applied to the left (undamaged) side of the scalp with an electrode covered with a damp cotton pad (25 cm2). The current will be applied for 15 minutes per day, with a total of 10 sessions over 3 weeks. |
| Action Training + tDCs | Experimental | Other: Transcranial direct current stimulation, Other: Action TrainingThis will involve the same procedure as in action training only but with tDCS applied for 15 minutes during the rodlifting. |
| Control training | Placebo comparator | –For the control training, patients will be asked to simply reach for the right hand side of each rod with their right (unaffected) hand and lift it |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic stroke affecting the right hemisphere, confirmed by CT or MRI.
- Persistent neglect for one month after ictus (confirmed by BIT).
- Prestroke functional independence (modified Rankin Scale score 0-2).
- Between 18-90 years of age
Key exclusion criteria (9 listed)
- Patients younger than 18.
- Patients who do not understand verbal or written English (ie.need of translaters)
- bilateral infarcts (Confirmed by CT, MRI)
- Dementia (MOCA, Score <26).
- Neurological Disease (eg. Parkinson's Disease, epilepsy, MS)
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 |
|---|---|---|
| Transcranial direct current stimulationAlso: tDCS | Other | Action Training + tDCs, tDCS |
| Action Training | Other | Action Training, Action Training + tDCs |
Primary outcome
Change in Behavioural Inattention Test (BIT)
Time frame: 6 months post intervention
6 secondary outcomes
Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
Time frame: baseline
Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
Time frame: 3 weeks
Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
Time frame: 6 months
Retention Numbers
Time frame: baseline
Retention Numbers
Time frame: 3 weeks
Retention Numbers
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
- 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.
- 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.
- Derived from this study: PubMed 32498606Learmonth G, Benwell CSY, Marker G, Dascalu D, Checketts M, Santosh C, Barber M, Walters M, Muir KW, Harvey M. Non-invasive brain stimulation in Stroke patients (NIBS): A prospective randomized open blinded end-point (PROBE) feasibility trial using transcranial direct current stimulation (tDCS) in post-stroke hemispatial neglect. Neuropsychol Rehabil. 2021 Sep;31(8):1163-1189. doi: 10.1080/09602011.2020.1767161. Epub 2020 Jun 5.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation and Action Training in people with Stroke, run by NHS Greater Glasgow and Clyde.
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 4 inclusion and 9 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 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Monika Harvey, BSc (hons), MSc, PhD (01413306174, monika.harvey@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Behavioural Inattention Test (BIT) (time frame: 6 months post intervention). 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 NCT02401724, which also lists 3 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 30 Mar 2015.