Non-invasive Brain Stimulation for People With Stroke

Completed

Phase 0 Results N/A

Trial Description

Every five minutes someone in the UK has a stroke. It is the main cause of long-term disability among adults in the UK despite a fall in age-specific stroke incidence, with a growing number of survivors remaining dependent for activities of daily living. While most people with stroke regain walking ability, upper limb problems with no voluntary arm and hand activity, affecting a third of people after stroke, has a poor prognosis. Transcranial direct current stimulation (tDCS) is a non-invasive procedure used to polarise brain regions through the application of weak direct currents and has the potential to develop into a useful aid to treatment strategies in neurorehabilitation. Recent literature into the application of tDCS in people with arm and hand impairments after stroke has shown promising results on upper limb function measures like the Jebsen-Taylor hand function test. Furthermore, a recent pilot study evaluated a six-week training programme combining tDCS with robot-assisted hand training and reported significant improvements in upper limb function. However, the robot in the latter study focused on single-plane distal movements only and long-term effects of the tDCS were not assessed. Recent robotic developments included robots with three rotational degrees-of-freedom for the upper limb, but the effectiveness of this type of robot combined with tDCS in early stroke settings is unknown. Ethical Approval was sought from NHS NRES Committee South Central- Southampton B (Ref: 11/SC/0345) to conduct this study.

Conditions

Interventions

  • Robot therapy and transcranial direct current stimulation Device
    Intervention Desc: Administration of Robot Therapy: Therapy will be administered by making use of the Armeo Robot. Sessions will involve high-intensity, repetitive, task-oriented movements directed by video screens. Administration of tDCS: Anodal tDCS will be administered using a CE marked transcranial Direct Current Stimulator (Newronika Italy). Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35 cm2).
    ARM 1: Kind: Experimental
    Label: Robot Therapy and Real Transcranial Direct Current Stimulation
    Description: This group will involve carrying out robot therapy and real transcranial Direct Current Stimulation (tDCS).
    ARM 2: Kind: Experimental
    Label: Robot Therapy and sham tDCS
    Description: Participants will be randomised to group 2 whereby they will carry out the same robot therapy programme however, receiving sham stimulation.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Report change in upper limb function from baseline to 8 weeks and 3 months after treatment Will be used, exactly before commencing training programme (day 1), at the end of the 8 week training programme and at 3 months follow-up No
Secondary Report change in cortical excitability from baseline to 8 weeks and 3 months after treatment Will be used, exactly before commencing training programme (day 1), at the end of the 8 week training programme and at 3 months follow-up No

Sponsors