NCT05792072

rTMS for the Treatment of Neuropathic Pain in Diabetic Patients

High Frequency rTMS for the Treatment of Neuropathic Pain in Diabetic Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Tis study aims to assess whether multiple sessions of sham-controlled HF-rTMS applied to the motor cortex significantly reduces treatment-resistant neuropathic pain in diabetic patients. This study will also investigate the effect of those rTMS sessions on functional connectivity of the M1 with brain areas involved in pain processing, underlying brain metabolism and brain plasticity using rs-fMRI, MRS and Paired-pulse stimulation respectively in those patients. Subjects will be randomized into two groups to receive real or sham rTMS protocol. A washout period of at least 8 weeks will be respected between protocols to minimize carry-over effects. Sham stimulation will be delivered using a sham coil, providing the same auditory and sensory stimuli. One daily rTMS session for 5 days of HF-rTMS, will be delivered through an H-coil applied to the primary motor area of the leg. Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100% of resting motor threshold (RMT), with an intertrain interval of 30s

Conditions

• Neuropathic Pain
• Diabetic Neuropathies

Interventions

Type	Name	Description
DEVICE	rTMS	High-frequency rTMS
DEVICE	Sham rTMS	sham rTMS

Timeline

• Start date: 2023-05-02
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2023-03-30
• Last updated: 2023-03-30

Locations

1 site across 1 country: Belgium