Enhancing Recovery of Arm Movement in Stroke Patients
Condition: Stroke; Arm; Paresis
MeSH terms: Paresis
Study type: Interventional

Summary: 
      Many people who have had a stroke have problems recovering the use of their affected arm and
      these problems may persist for a long time. The investigators' research will test new ways to
      boost recovery by using non-painful brain stimulation together with training of arm movements
      using basic science principles. The training program will be done using the latest technology
      in rehabilitation such as virtual reality and robotics. The investigators will compare three
      groups of patients who have had a stroke. Each group will receive different combinations of
      brain stimulation and arm training. Another aspect of this proposal is that the investigators
      will do the same training programs in three different countries - Canada, Israel and India.
      In this way, the investigators will combine knowledge and skills to create training programs
      that can be applied anywhere in the world and that are not necessarily limited to high-income
      countries. Also, by combining expertise, the investigators will help to build the capacity to
      do research in India, a middle-income country that has great potential to contribute new
      knowledge to rehabilitation medicine.
    

Detailed description: 
      Training approaches based on established principles of motor learning and neural plasticity
      and non-invasive brain stimulation such as repetitive Transcranial Magnetic Stimulation and
      transcranial Direct Current Stimulation (tDCS) show promise in modulating brain activity in
      order to enhance upper limb (UL) motor recovery. However, the potential for recovery may
      still not be attained if training programs do not specifically focus on remediating motor
      impairment as defined by motor control science. This project is driven by a major theory of
      motor control (Threshold Control Theory) suggesting that rather than directly specifying
      motor commands to muscles, descending systems regulate spatial thresholds (STs) of reflexes
      to generate and control voluntary movement within specific areas of joint space. In patients
      with stroke, ST control is diminished leading to the appearance of muscle spasticity,
      weakness and abnormal muscle activation patterns during voluntary movement within
      well-defined spatial (angular) zones. The investigators hypothesize that recovery of
      voluntary motor control is tightly linked to the recovery of threshold control. The
      investigators propose a training program that incorporates personalized tDCS to balance
      cortical hypo/hyperexcitability as well as personalized movement arm reaching training based
      on the identification of disorders in ST.

      Overall objectives of the proposal are:

        1. To test the effectiveness of personalized training programs to increase the range of
           regulation of STs in the elbow during reaching.

        2. To determine the effects of repetitive tDCS aimed at inhibiting excessive/exciting
           diminished cortical activity.

        3. To determine the feasibility of implementing personalized training programs in high and
           low-to-middle income countries.

      Sixty patients with sub-acute (3 wks-6 mos) stroke will be recruited in this multi-site
      international trial taking place in Canada, Israel and India. Participants will have
      spasticity in the elbow flexors and/or extensors, with some active elbow control. Each site
      will recruit and randomize patients into one of 3 treatment groups. Group 1 will receive tDCS
      and practice personalized arm motor training. Group 2 will also receive tDCS with
      non-specific practice. Group 3 will receive Sham-tDCS and personalized practice. Training
      will consist of the application of tDCS in the first 30 minutes of a 50-minute arm reaching
      practice session,, 5 days per week for 2 weeks. Primary outcome measures (Pre, Post,
      Follow-up) are elbow flexor and extensor STs and related spasticity/active control zones.
      Secondary measures are clinical measures of UL motor activity. By accounting for the spatial
      structure of motor deficits, our research will benefit both researchers and clinicians by
      advancing our understanding of the mechanisms underlying unimpaired/impaired motor control
      and recovery.
    

Intervention name(s): tDCS; sham tDCS; personalized practice; non-personalized practice
Intervention type(s): Device; Device; Behavioral; Behavioral
Intervention description(s): Application of 1.5 mA tDCS for 30 minutes; Application of sham tDCS for 30 minutes; arm exercise consisting of whole arm movement within a restricted elbow range of motion; arm exercise consisting of unrestricted whole arm movement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Direct Current Stimulation; Arm Training; Virtual Reality Exposure Therapy