Enhancing Recovery of Arm Movement in Stroke Patients "ENHANCE"

Recruiting

Phase N/A Results N/A

Trial Description

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 25 mins of tDCS following by 50 min arm reaching practice sessions, 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.

Conditions

Interventions

  • TDCS Device
    Intervention Desc: Application of 2mA tDCS for 25 minutes
    ARM 1: Kind: Experimental
    Label: tDCS + personalized practice
    Description: Transcranial direct current stimulation and personalized arm motor training limited to active control zones, 1 hour per day, 5 days per week for 2 weeks
    ARM 2: Kind: Experimental
    Label: tDCS + non-personalized practice
    Description: Transcranial direct current stimulation and non-personalized arm motor training spanning both active control and spasticity zones, 1 hour per day, 5 days per week for 2 weeks
  • Sham tDCS Device
    Intervention Desc: Application of sham tDCS for 25 minutes
    ARM 1: Kind: Experimental
    Label: sham tDCS + personalized practice
    Description: Sham transcranial direct current stimulation and personalized arm motor training limited to active control zones, 1 hour per day, 5 days per week for 2 weeks
  • TDCS + personalized practice Behavioral
    Intervention Desc: Application of tDCS and training will consist of 25 mins of tDCS following by 50 min or personalized arm reaching practice sessions, 5 days per week for 2 weeks.
    ARM 1: Kind: Experimental
    Label: tDCS + personalized practice
    Description: Transcranial direct current stimulation and personalized arm motor training limited to active control zones
  • TDCS + practice Behavioral
    Intervention Desc: Application of tDCS and training will consist of 25 mins of tDCS following by 50 min of non-specific arm reaching practice sessions, 5 days per week for 2 weeks.
    ARM 1: Kind: Experimental
    Label: tDCS + practice
    Description: Transcranial direct current stimulation and arm motor training spanning both active control and spasticity zones
  • Sham + personalized practice Behavioral
    Intervention Desc: Application of sham tDCS and training will consist of 25 mins of sham tDCS following by 50 min or personalized arm reaching practice sessions, 5 days per week for 2 weeks.
    ARM 1: Kind: Experimental
    Label: sham + personalized practice
    Description: Sham transcranial direct current stimulation and personalized arm motor training limited to active control zones
  • Personalized practice Behavioral
    Intervention Desc: arm exercise consisting of whole arm movement within a restricted elbow range of motion
    ARM 1: Kind: Experimental
    Label: tDCS + personalized practice
    Description: Transcranial direct current stimulation and personalized arm motor training limited to active control zones, 1 hour per day, 5 days per week for 2 weeks
    ARM 2: Kind: Experimental
    Label: sham tDCS + personalized practice
    Description: Sham transcranial direct current stimulation and personalized arm motor training limited to active control zones, 1 hour per day, 5 days per week for 2 weeks
  • Non-personalized practice Behavioral
    Intervention Desc: arm exercise consisting of unrestricted whole arm movement
    ARM 1: Kind: Experimental
    Label: tDCS + non-personalized practice
    Description: Transcranial direct current stimulation and non-personalized arm motor training spanning both active control and spasticity zones, 1 hour per day, 5 days per week for 2 weeks

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in active control zone of the elbow after 2 weeks of intervention No
Secondary Change in Fugl-Meyer Assessment of Arm impairment Score after 2 weeks of intervention No
Secondary Change in spasticity score after 2 weeks of intervention No
Secondary Change in streamlined Wolf Motor Function Test score after 2 weeks of intervention No
Secondary Change in active range of elbow extension after 2 weeks of intervention No
Secondary Change in straightness of elbow trajectory during a reach to grasp task after 2 weeks of intervention No
Secondary Change in speed of endpoint movement during a reach to grasp task after 2 weeks of intervention No
Secondary Change in smoothness of endpoint trajectory during a reach to grasp task after 2 weeks of intervention No

Sponsors