A Novel Approach for Brain Stimulation in Severe Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The long-term goal of this project is to develop upper limb rehabilitation interventions that
      can be utilized for stroke survivors, specifically survivors with more severe limitations in
      use of their affected upper limb.

      This study will utilize a novel method of non-invasive brain stimulation in conjunction with
      upper limb training given for 12 visits over a period of 6 weeks.

      The study will include the following site visits:

        -  Eligibility Screening and Informed Consent Visit

        -  An MRI visit

        -  Two testing visits in which motor function of the upper limb and neurophysiology will be
           measured

        -  12 intervention visits during which patients will receive upper limb training in
           conjunction with non-invasive brain stimulation

        -  Repeat testing of motor function of the upper limb and neurophysiology

        -  Repeat MRI testing

        -  A follow-up visit completed 3 months after the completion of interventions
    

Detailed description: 
      In a pilot, randomized clinical trial, 24 stroke patients with moderate/severe impairments
      will receive non-invasive brain stimulation (repetitive Transcranial Magnetic Stimulation or
      rTMS) to one of two targets in the brain in conjunction with upper limb training for 2 days a
      week for 6 weeks. The primary outcome will be upper limb motor impairment, and secondary
      outcomes will be tests of functional abilities, proximal motor control, and patient-reported
      disability. Associated neural mechanisms will also be studied using neurophysiological and
      functional connectivity MRI techniques. Damage to ipsilesional corticospinal pathways will be
      indexed with diffusion tensor imaging (DTI).
    

Intervention name(s): New rTMS Approach; Conventional rTMS Approach
Intervention type(s): Device; Device
Intervention description(s): Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.; Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
Other intervention name(s): cPMd rTMS + Training; iM1 rTMS + Training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In a pilot, randomized, assessor-blind clinical trial, an anticipated 24 patients will be assigned to either receive stimulation to a new brain target- contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere- or the conventional brain target- ipsilesional primary motor cortex (iM1) located in the stroke hemisphere. Stimulation will be delivered in conjunction with rehabilitation for 2 days a week for 6 weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; brain stimulation; TMS; Upper Limb; MRI; CVA; Rehabilitation