NonInvasive Brain Stimulation in Stroke Patients
RTNIBS
A Randomised Trial of Non-Invasive Brain Stimulation (NIBS) in Stroke Survivors
1 other identifier
interventional
60
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Mar 2015
Typical duration for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMarch 30, 2015
March 1, 2015
3.3 years
March 10, 2015
March 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Behavioural Inattention Test (BIT)
6 months post intervention
Secondary Outcomes (6)
Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
baseline
Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
3 weeks
Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
6 months
Retention Numbers
baseline
Retention Numbers
3 weeks
- +1 more secondary outcomes
Study Arms (4)
Action Training
ACTIVE COMPARATORTraining exercise which involves patients lifting up rods of different sizes and shifting their grip if this is too far to one side
tDCS
EXPERIMENTALA 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
EXPERIMENTALThis will involve the same procedure as in action training only but with tDCS applied for 15 minutes during the rodlifting.
Control training
PLACEBO COMPARATORFor 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Alcohol excess (more than 50/40 units a week for men/women respectively).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Greater Glasgow and Clydelead
- University of Glasgowcollaborator
Related Publications (3)
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.
PMID: 34196963DERIVEDElsner 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.
PMID: 33175411DERIVEDLearmonth 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.
PMID: 32498606DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2015
First Posted
March 30, 2015
Study Start
March 1, 2015
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
March 30, 2015
Record last verified: 2015-03