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NonInvasive Brain Stimulation in Stroke Patients (RTNIBS)

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Action Training
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Hemispatial neglect, Transcranial direct current stimulation, Rehabilitation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ischemic stroke affecting the right hemisphere, confirmed by CT or MRI.
  2. Persistent neglect for one month after ictus (confirmed by BIT).
  3. Prestroke functional independence (modified Rankin Scale score 0-2).
  4. Between 18-90 years of age

Exclusion Criteria:

  1. Patients younger than 18.
  2. Patients who do not understand verbal or written English (ie.need of translaters)
  3. bilateral infarcts (Confirmed by CT, MRI)
  4. Dementia (MOCA, Score <26).
  5. Neurological Disease (eg. Parkinson's Disease, epilepsy, MS)
  6. Significant morbidity (eg cancer, severe cardiac failure) likely to affect participation.
  7. Alcohol excess (more than 50/40 units a week for men/women respectively).
  8. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Action Training

    tDCS

    Action Training + tDCs

    Control training

    Arm Description

    Training exercise which involves patients lifting up rods of different sizes and shifting their grip if this is too far to one side

    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.

    This will involve the same procedure as in action training only but with tDCS applied for 15 minutes during the rodlifting.

    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

    Outcomes

    Primary Outcome Measures

    Change in Behavioural Inattention Test (BIT)

    Secondary Outcome Measures

    Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
    Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
    Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
    Retention Numbers
    Retention Numbers
    Retention Numbers

    Full Information

    First Posted
    March 10, 2015
    Last Updated
    March 27, 2015
    Sponsor
    NHS Greater Glasgow and Clyde
    Collaborators
    University of Glasgow
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02401724
    Brief Title
    NonInvasive Brain Stimulation in Stroke Patients
    Acronym
    RTNIBS
    Official Title
    A Randomised Trial of Non-Invasive Brain Stimulation (NIBS) in Stroke Survivors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    June 2018 (Anticipated)
    Study Completion Date
    June 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NHS Greater Glasgow and Clyde
    Collaborators
    University of Glasgow

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Hemispatial neglect, Transcranial direct current stimulation, Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Action Training
    Arm Type
    Active Comparator
    Arm Description
    Training exercise which involves patients lifting up rods of different sizes and shifting their grip if this is too far to one side
    Arm Title
    tDCS
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Action Training + tDCs
    Arm Type
    Experimental
    Arm Description
    This will involve the same procedure as in action training only but with tDCS applied for 15 minutes during the rodlifting.
    Arm Title
    Control training
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Transcranial direct current stimulation
    Other Intervention Name(s)
    tDCS
    Intervention Type
    Other
    Intervention Name(s)
    Action Training
    Primary Outcome Measure Information:
    Title
    Change in Behavioural Inattention Test (BIT)
    Time Frame
    6 months post intervention
    Secondary Outcome Measure Information:
    Title
    Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
    Time Frame
    baseline
    Title
    Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
    Time Frame
    3 weeks
    Title
    Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
    Time Frame
    6 months
    Title
    Retention Numbers
    Time Frame
    baseline
    Title
    Retention Numbers
    Time Frame
    3 weeks
    Title
    Retention Numbers
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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). 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Monika Harvey, BSc (hons), MSc, PhD
    Phone
    01413306174
    Email
    monika.harvey@glasgow.ac.uk

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34196963
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    33175411
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    32498606
    Citation
    Learmonth 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. Erratum In: Neuropsychol Rehabil. 2022 Jun;32(5):794-795.
    Results Reference
    derived

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    NonInvasive Brain Stimulation in Stroke Patients

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