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rTMS for the Treatment of Neuropathic Pain in Diabetic Patients

NCT05792072 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-30

No results posted yet for this study

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

DEVICE

rTMS

High-frequency rTMS

DEVICE

Sham rTMS

sham rTMS

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05792072 on ClinicalTrials.gov