NCT05489146

t-RNS After Hand Recovery in Chronic Stroke

Combining Transcranial Random Noise Stimulation and Functional Electrical Stimulation to Enhance Hand Function in Individuals With Chronic Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Amit Sethi · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	transcranial random noise stimulation and functional electrical stimulation facilitated task practice	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.

Timeline

• Start date: 2015-01-15
• Primary completion: 2020-03-15
• Completion: 2020-03-15
• First posted: 2022-08-05
• Last updated: 2022-12-28
• Results posted: 2022-12-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study