An interventional study of Suprathreshold repetitive peripheral sensory stimulation and Subthreshold repetitive sensory stimulation in Stroke, sponsored by Hospital Israelita Albert Einstein. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Hospital Israelita Albert Einstein · Not applicable, Interventional, and Treatment
Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral sensory stimulation (RPSS) is a novel strategy to improve upper limb motor performance in the post-stroke chronic phase but its effects in the subacute phase are still poorly understood. The objectives of this study are to compare the effects of RPSS on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 51 is close to the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Hospital Israelita Albert Einstein is the lead sponsor of 147 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Repetitive peripheral sensory stimulation (RPSS) + Motor Training. Suprathreshold RPSS will be administered for 2 hours. After RPES, the patient will receive motor training.
Device: Suprathreshold repetitive peripheral sensory stimulation
Other: Subthreshold RPSS + Motor Training. Subthreshold RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training
Device: Subthreshold repetitive sensory stimulation
Repetitive peripheral sensory stimulation (RPSS) + Motor Training. Suprathreshold RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training.
Device: Suprathreshold repetitive peripheral sensory stimulation
Other: Subthreshold RPSS + Motor Training. RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training
Device: Subthreshold repetitive sensory stimulation
Suprathreshold repetitive peripheral sensory stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For suprathreshold stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required.
Subthreshold repetitive sensory stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For subthreshold stimulation, intensities will be set at 10mv - 15mv lower than de lowest intensity able to induce sensory paraesthesias, and adjusted if required.
Change in Jebsen-Taylor Test
Test of upper limb dexterity
Time frame: Immediately after one session of intervention
Change in lateral pinch strength
Pinch strength measured with dynamometer
Time frame: Immediately after one session of intervention
Change in gamma-aminobutyric acid levels in primary motor cortex
Gamma-aminobutyric acid levels measured with magnetic resonance imaging spectroscopy
Time frame: Immediately after one session of intervention
Change in brain perfusion
Brain perfusion measured with magnetic resonance imaging - arterial spin labeling
Time frame: Immediately after one session of intervention
Change in grasp strength
Grasp strength measured with dynamometer
Time frame: Immediately after one session of intervention
Plan to share: Undecided
Ran from Dec 2019 to primary completion in Nov 2022, 35 months.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 35 months is above that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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