NonInvasive Brain Stimulation in Stroke Patients "RTNIBS"

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Transcranial direct current stimulation Device
    ARM 1: Kind: Experimental
    Label: tDCS
    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 2: Kind: Experimental
    Label: Action Training + tDCs
    Description: This will involve the same procedure as in action training only but with tDCS applied for 15 minutes during the rodlifting.
  • Action Training Other
    ARM 1: Kind: Experimental
    Label: Action Training
    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 2: Kind: Experimental
    Label: Action Training + tDCs
    Description: This will involve the same procedure as in action training only but with tDCS applied for 15 minutes during the rodlifting.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Behavioural Inattention Test (BIT) 6 months post intervention No
Secondary Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed) baseline No
Secondary Retention Numbers baseline No

Sponsors