Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Intervention: real-tDCS with MI-BCI
Intervention description: As in Arm Description
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Stroke; Noninvasive brain stimulation; Brain-computer interface; Motor imagery; Rehabilitation

Summary:

      Stroke is the most common cause of adult disability. Current treatments for functional loss
      of the upper extremity post-stroke remain limited in efficacy, particularly for those with
      moderate to severe impairment.

      Previous studies have demonstrated the efficacy of transcranial direct current stimulation
      (tDCS) for motor recovery post-stroke, a technique of neuromodulation. Motor imagery is
      effective to enhance motor recovery, with activation of neural pathways similar to that of
      motor execution. This treatment is accessible to more severely impaired stroke survivors. Our
      previous studies have demonstrated feasibility and efficacy of motor imagery-based brain
      computer interface (MI-BCI) for post-stroke motor impairment, in which motor imagery is
      detected by surface EEG and translated to execution of the target movement with the aid of an
      arm robot (MIT-Manus).

      In this study, we investigate the feasibility of combining robot-assisted MI-BCI training,
      with tDCS to facilitate post-stroke motor recovery in moderate to severe impairment of upper
      extremity function. We hypothesise that both tDCS-BCI and sham-BCI will improve motor
      function in the stroke-affected arm; but that tDCS-BCI will be more effective than sham-BCI.
      Our secondary aim is to gain insight into the neurophysiological mechanism by comparing the
      cortical excitability changes following sham-BCI vs tDCS-BCI, using transcranial magnetic
      stimulation (TMS).

      We will conduct a randomized, double-blinded study with MI-BCI combined with tDCS (tDCS-BCI)
      vs MI-BCI combined with sham-tDCS (sham tDCS-BCI). Subjects will undergo 10 sessions of tDCS
      each lasting 20 minutes, followed by 40 minutes of robot-assisted MI-BCI training at each
      session. Primary outcome will be functional ability measured by upper extremity component of
      the Fugl-Meyer Assessment. Secondary outcome measures will be the Box & Block Test, Modified
      Ashworth Score (measuring spasticity), grip strength and measures of brain activity including
      transcranial magnetic stimulation (TMS) measures of magnetic resonance imaging (MRI) measures
      including functional MRI and diffusion tensor imaging (DTI).

      This study will be important to develop a new and effective treatment (tDCS-BCI) for
      post-stroke motor impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  first ever haemorrhagic or ischaemic subcortical stroke more than 9 months prior to
             study enrollment

          -  upper extremity impairment of 11-45 on the Fugl-Meyer assessment scale

        Exclusion Criteria:

          -  epilepsy

          -  neglect

          -  cognitive impairment

          -  other neurological or psychiatric diseases

          -  severe arm pain

          -  spasticity score >2 on the Modified Ashworth Scale in the shoulder or elbow

          -  contraindications to TMS or tDCS (cranial implants, ventricular shunts, pacemakers,
             intrathecal pumps)

          -  grip strength <10kg as measured by a dynamometer

          -  participation in other interventions or trials targeting stroke motor recovery.