rTMS for the Treatment of Neuropathic Pain in Diabetic Patients

NCT ID: NCT05792072

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2025-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

active rTMS

The patient will receive one daily rTMS session for 5 days of HF-rTMS, 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

Group Type: ACTIVE_COMPARATOR

rTMS

Intervention Type: DEVICE

High-frequency rTMS

Sham rTMS

Sham stimulation will be delivered using a sham coil.

Group Type: SHAM_COMPARATOR

Sham rTMS

Intervention Type: DEVICE

sham rTMS

Interventions

rTMS

High-frequency rTMS

Intervention Type: DEVICE

Sham rTMS

sham rTMS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Written informed consent to participate in this study is obtained
• The subject is an out-patient aged 18 years or above with diabetes mellitus type 1 or 2
• The patient has laboratory-confirmed diabetes
• Patients are diagnosed with peripheral neuropathy based on clinical and electrophysiological findings
• A score of > /= 4 on the the 'Douleur Neuropathique en 4 Questions' (DN4) questionnaire (30), conforming the diagnosis of neuropathic pain.
• The patient has a painful diabetic neuropathy for at least 6 months
• The patient has a Numeric pain rating scale (NPRS) score >/= 4.
• The patient is resistant to standard therapies for neuropathic pain

Exclusion Criteria

• The patient has an implanted cardiac device, such as a pacemaker or a defibrillator
• The patient has an implanted neurostimulator
• The patient has cochlear implants/ear implants, magnetic dental im-plants
• The patient has a drug infusion pump
• The patient has cerebral artery aneurysm clips
• The patient has a history of epilepsy
• The patient has a history of migraine or severe headaches
• The patient has significant psychiatric disorders
• For female patients: the subject is pregnant or lactating
• Other formal contra-indication for rTMS or MRI

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University hospital Brussels

Brussels, Jette, Belgium

Countries

Belgium

Other Identifiers

TMSDIAB2021

Identifier Type: -

Identifier Source: org_study_id