Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of intermittent theta burst stimulation
      primed with continous theta burst stimulation (cTBS), on top of a standard robot-assisted
      training (RAT) on improving the upper limb motor functions of stroke survivors and to explore
      potential sensorimotor neuroplasticity with electroencephalography (EEG).
    

Detailed description: 
      Intermittent theta burst stimulation (iTBS) delivered to the affected primary motor cortex
      (M1) appears to enhance the brain response to rehabilitative intervention in patients with
      stroke. However, its clinical utility is highly affected by the response variability. New
      evidence has reported that preceding iTBS with a priming session of continuous theta burst
      stimulation (cTBS), may stabilize and even boost the facilitatory effect of iTBS on the
      stimulated M1, via metaplasticity. The aim of this study is to investigate the effects of
      iTBS primed with cTBS, on top of a standard robot-assisted training (RAT) on improving the
      upper limb motor functions of patients with chronic stroke and to explore potential
      sensorimotor neuroplasticity with electroencephalography (EEG). A three-arm randomized
      controlled trial (RCT) will be performed with an estimated total of 36 patients with subacute
      or chronic stroke. All participants will be randomly allocated to receive 10-session
      intervention of different TBS protocols (i.e., cTBS+iTBS, sham cTBS+iTBS and sham cTBS+sham
      iTBS), delivered for 3-5 sessions per week, lasting for 2-3 weeks. All participants will
      receive a 60-minute standard RAT after each stimulation session. Primary outcome will be
      Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE). Secondary outcomes will be Action
      Research Arm Test (ARAT), kinematic outcomes generated during RAT as well as and EEG.
    

Intervention name(s): Theta burst stimulation (TBS); Robot-assisted training
Intervention type(s): Device; Behavioral
Intervention description(s): Theta burst stimulation (TBS) is a potent form of repetitive transcranial magnetic stimulation (rTMS). Standard 600-pulse intermittent theta burst stimulation (iTBS) can enhance the corticomotor excitability, whereas standard 600-pulse continuous theta burst stimulation (cTBS) can suppress the corticomotor excitability. Sham stimulation uses an extreme low stimulation intensity which will not influence with corticomotor excitability. In the present study, real stimulation will be delivered in an intensity of 70% individual resting motor threshold while sham stimulation will be delivered in an intensity of 20% individual resting motor threshold.; Fourier M2 upper limb rehabilitation robot (Fourier Intelligence Co. Ltd., Shanghai, China), will be used for upper limb proximal joints training. Fourier M2 upper limb rehab robot is an end-effector robot-assisted device. The device targets (1) flexion and extension of shoulder joint, (2) flexion and extension of elbow, (3) internal and external rotation of shoulder joint, and (4) abduction and adduction of shoulder joint, supported by tailored interactive TV games in the device. HandyRehab hand robot (Zunosaki Company Ltd., Hong Kong SAR) will be used for upper limb distal joints training. It is an exoskeleton over the hand which provides power-driven extension and grasping force to the fingers and thumb in order to assist the patient to open and close the paretic hand by means of surface electromyography-triggered from the signals through the forearm extensors and flexors.
Other intervention name(s): Repetitive transcranial magnetic stimulation (rTMS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; theta burst stimulation; upper limb; metaplasticity; priming