NCT03354052

Efficacy of rTMS on Pain Following Stroke.

Efficacy of rTMS on Pain Following Stroke: a Pilot Randomized Control Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital of Ferrara · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Pain is a common symptom experienced by people following stroke and can significantly interfere with participation in the activities of daily living and adversely affect health-related quality of life. Repetitive Transcranial Magnetic Stimulation (rTMS) promotes the modulation of brain activity and its prolonged and continuous application can effect plastic modification. Combining rTMS with rehabilitation treatment for primary motor cortex activation (using Gloreha® device) may have effect in reducing pain in stroke survivors. This is a pilot randomized control trial to test the effects of rTMS in stroke-related pain rehabilitation, its efficacy on pain, upper limb function, sensory function and autonomy in daily livings activities. Furthermore, we will explore the effects on pressure pain threshold, cortical excitability and EEG recording.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Real-rTMS + Gloreha device	The real rTMS will be delivered using a 8-shaped coil placed over the primary motor cortex (M1). The resting motor threshold (RMT) will be assessed at the place of the first dorsal interosseous (FDI) contralateral to the stimulated cortex. RMT of the FDI will be determined as the lowest strength of TMS needed to elicit 5 or more electromyographic responses ≥50 μV within 10 trials. Stimulation will be applied with frequency 10 Hz and intensity of 90% of RMT. Every session will last 15 minutes and includes 3000 pulses (30 trains of 10 seconds, following intertrain interval of 20 seconds). Rehabilitation programme will last 30 minutes and will be delivered using Gloreha® device, a proprioceptive stimulator under visual feedback. All the subjects enrolled will receive treatments for 2 weeks, 5 days per week.
DEVICE	Sham-rTMS + Gloreha device	The sham rTMS will be delivered using a sham stimulator. All procedures will be performed as for the real treatment. Rehabilitation programme will last 30 minutes and will be delivered using Gloreha® device, a proprioceptive stimulator under visual feedback. All the subjects enrolled will receive treatments for 2 weeks, 5 days per week.

Timeline

• Start date: 2017-12-01
• Primary completion: 2022-12-01
• Completion: 2023-05-01
• First posted: 2017-11-27
• Last updated: 2022-05-25

Locations

1 site across 1 country: Italy