t-RNS After Hand Recovery in Chronic Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Upper extremity (UE) paresis or weakness is one of the most frequent impairments after
      stroke. Despite intense rehabilitation, motor and functional recovery of patients with severe
      hand impairments is poor. Hence, there is a need for more effective treatments to enhance
      motor function in patients with severe hand impairments after stroke. Adaptive functional
      electrical stimulation (FES) appears to be a promising treatment and has the potential to
      facilitate active movement in individuals with severe impairments post-stroke. In addition,
      transcranial random noise stimulation (trns) is a widely studied, non-invasive and safe
      method to enhance the corticomotor excitability in individuals with chronic stroke. However,
      the effect of combining trns and adaptive FES in patients with severe hand impairments has
      not been investigated. Therefore, the purpose of this study is to investigate whether
      combining trns with FES will enhance hand function in individuals with chronic stroke than
      FES alone. The investigators predict that combining trns with FES will significantly enhance
      hand function than FES alone.
    

Detailed description: 
      The primary purpose of this study was to investigate whether combining transcranial random
      noise stimulation with functional electrical stimulation-facilitated task practice will
      enhance hand function in individuals with severe paresis post-stroke than functional
      electrical stimulation alone.

      The study is an experimental randomized study comparing the effects of transcranial random
      noise stimulation with functional electrical stimulation to functional electrical stimulation
      alone on recovery of function in the more-affected hand in individuals with chronic stroke.

      Participants were randomized to receive transcranial random noise stimulation and functional
      electrical stimulation-facilitated task practice or sham-transcranial random noise
      stimulation and functional electrical stimulation-facilitated task practice.

      Participants received 18 treatment sessions over 6 weeks (3 times/week for 6 weeks).
    

Intervention name(s): transcranial random noise stimulation and functional electrical stimulation facilitated task practice
Intervention type(s): Device
Intervention description(s): Participants were randomized to one of the two intervention groups [transcranial current stimulation (tRNS) and functional electrical stimulation (FES) or FES with sham tRNS] before pre-intervention testing. After randomization, participants underwent pre-intervention testing, followed by intervention 3 times per week for 6 weeks. Each intervention session lasted for 1 hour, where tRNS or sham-tRNS were delivered concurrently with the FES-facilitated task practice. tRNS or sham-tRNS was delivered for the first 30 minutes. Both tRNS and sham tRNS were delivered by the Starstim system. FES was delivered using the Neuromove system. All participants were treated by a licensed occupational therapist, who was trained on a manualized protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; hand; brain stimulation