New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke.
Condition: Cerebral Vascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The fundamental goals of early rehabilitation for patients with stroke are: optimizing motor
      function within each patient's prognostic potential, preventing the development of secondary
      conditions that impact life-long health, and promoting patient's participation in their
      lives. In addition to employ clinical measures after treatment, usual outcome measures
      employed in the intervention studies included movement kinematics (spatio-temporal
      characteristics of movements). Recent reports have suggested repetitive transcranial magnetic
      stimulation (rTMS) and BoNTA (BoNTA) improved motor function in patients with stroke. A novel
      rTMS paradigm, theta burst stimulation (TBS), including intermittent TBS (iTBS) and
      continuous TBS (cTBS), that modulates human cortical excitability differently. However, there
      is lack of literatures in verifying the treatment effect by the integration of clinical and
      kinematic analysis. Until now, there are no conclusive results regarding optimal rTMS
      protocol, such as stimulating pattern and for patients with stroke. Additionally, few studies
      investigate the possible clinical characteristics of patients with stroke that may influence
      the effects of various treatment protocols proposed in this project.
    

Detailed description: 
      The research program aims at studying patients with stroke the immediate and maintaining
      effects of new upper-extremity (UE) treatment protocols after brain damage and identifying
      the possible mechanisms underlying treatment-induced changes in patients with stroke. This
      research will study new treatment approaches that have been formulated based on principles of
      integrated central modulation (rTMS) and peripheral modification techniques (BoNTA).

        1. To compare the movement functions and motor control in patients with stroke of different
           motor severities.

        2. To investigate the immediate and maintaining effects of different protocols in the
           treatment of upper limb functions.

        3. To evaluate motor control and clinical outcomes after different treatment approaches
           applied in the UE training of patients with stroke. The treatment approaches to be
           studied will include different protocols. We hypothesize that there will be improvements
           in movement performance after the treatment and the level of post-treatment performance
           will differ among the treatments through different reorganization patterns.

           3.1 To compare the motor control and clinical outcomes after different treatment
           approaches.

           3.2 To identify the optimal treatment protocol for patients with stroke.

        4. To investigate the possible predictors of treatment outcome associated with motor
           severity, movement and participation for each type of treatments. The possible
           predictors will include brain lesions, and severity. We hypothesize that the proposed
           prognostic factors will predict treatment outcomes.

        5. To analyze the association between motor reorganization measured by kinematic study and
           behavioral improvement in motor severity, movement and participation measured by
           clinical tools.

      Treating motor dysfunction in patients with stroke requires an understanding of the mechanism
      underlying motor control. Recent reports have suggested BoNTA and rTMS improved motor
      function in patients with various disorders. However, there are few researches in identifying
      the optimal rTMS protocol in the treatment of upper limb dysfunctions in patients with
      stroke. There is lack of literatures in verifying the treatment effect by movement control
      studies. The current research will offer valuable kinematic data that support neural-motor
      models proposed to account for motor control problems in these patients. More important, we
      will identify the new protocol in the treatment of upper limb dysfunctions in patients with
      stroke through integration of clinical and kinematic measures. We will identify clinical
      predictors influencing the outcome for different treatment approaches, and analyze the
      association between motor control and clinical measures involving motor severity, movement
      and participation. We believe the results of this study will refine services and supports for
      patients with stroke to meet these goals. This study may potentially provide directions in
      kinematic measures for future studies on patients with stroke.
    

Intervention name(s): intermittent theta burst stimulation; continuous theta burst stimulation; sham theta burst stimulation
Intervention type(s): Other; Other; Other
Intervention description(s): In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (low pulse: 600 pulses in total); In continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds(low pulse: 600 pulses in total).; In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds(almost no pulse: 600 pulses in total).
Other intervention name(s): continuous burst stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: repetitive transcranial magnetic stimulation; BoNTA; stroke; optimal treatment protocol; randomized controlled trial; motor control; clinical predictors