Treatment for Diabetic Neuropathy Using Repetitive Transcranial Magnetic Stimulation
NCT Number: NCT06482827
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Neuropathies
Interventions: DEVICE: Sham Repetitive transcranial magnetic stimulation|DEVICE: Repetitive transcranial magnetic stimulation
Sponsor: McMaster University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-12-01
Locations: McMaster University, Hamilton, Ontario, L8S4L1, Canada

Summary:
The aim of this study is to determine whether a 4-week treatment of repetitive transcranial magnetic stimulation (rTMS) can alleviate the symptoms of neuropathy in individuals with diabetic neuropathy. The study will involve using questionnaires, nerve assessments, sensory tests, blood flow measurements, and blood tests to monitor any changes in symptoms after the rTMS intervention.

Primary Outcome Measures: Modified Toronto Clinical Neuropathy Score, Will be used to assess the presence and severity of diabetic neuropathy ('yes' or 'no'), Immediately before intervention, immediately following intervention, 4 weeks after intervention|PROMIS-29 v2.0 Profile, Using numerical rating (0 to 5) to assess seven health domains including physical function, anxiety, depression, fatigue, sleep disturbances, ability to participate in social roles and activities, and pain interference. Each category consists of 4 questions. Also uses a numerical rating to asses pain intensity (0-10)., Immediately before intervention, immediately following intervention, 4 weeks after intervention|Patient Perceived Global Index of Change (PGIC), 1-7 Likert Scale: Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse, Immediately following intervention, 4 weeks after intervention|Pain catastrophizing scale-EN-SF, Will be used to assess the patients feeling and emotion related to their pain experience, Immediately before intervention, immediately following intervention, 4 weeks after intervention
Secondary Outcome Measures: Change in quantitative sensory testing, Will be used in this study to assess somatosensory function to determine underlying pain mechanisms for pain phenotypes. QST will be used to measure detection thresholds for cold, warm, vibration, and mechanical stimuli. Pain thresholds will be assessed for cold, heat, mechanical, and pressure stimuli. In addition, allodynia will be measured., Immediately before intervention, immediately following intervention, 4 weeks after intervention|Change in nerve conduction assessments, Non-invasive peripheral nerve stimulation will be delivered using surface bar electrodes placed over the tibial nerve at the popliteal fossa and the medial malleolus. Compound muscle action potential will be recorded with surface electromyography over soleus, gastrocnemius, and abductor hallucis. These measures will be obtained from both lower limbs., Immediately before intervention, immediately following intervention|Change in blood flow, Will use color Doppler ultrasound to measure hemodynamic characteristics in diabetic neuropathy. Six major arteries that are responsible for supplying blood to the foot sole will be evaluated including the first common plantar artery, second common plantar artery, third common plantar artery, fourth common plantar artery, posterior tibial artery, and fibular side of the first plantar toe proper artery., Immediately before intervention, immediately following intervention|Changes in wound, Will use the app called Swift Skin and Wound to track the changes in wound size over the course of the study, Immediately before intervention, immediately following intervention|Change in inflammation markers (IL-1B, IL-6, IL-10, TNF-α, TGF-β, CRP, SP, and BDNF), 10 mL of blood will be collected to assess the changes in the levels of inflammatory markers (IL-1B, IL-6, IL-10, TNF-α, TGF-β, CRP, SP, and BDNF), Immediately before intervention, immediately following intervention