rTMS for the Treatment of Neuropathic Pain in Diabetic Patients

NCT05792072 | Unknown

• 1 other identifier: TMSDIAB2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Changes in pain severity

  Neuropathic pain rating scale; Scores are based on patient responses to questions about pain intensity. 0 indicates no pain; 10 indicates the most pain imaginable

  The NPRS will be controlled at following time points: prior to the initiation of the rTMS protocol, and then weekly until 2 months after the last treatment.

• Changes in functional connectivity of the M1 with brain areas involved in pain processing

  rs-fMRI will be used

  rs-fMRI will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment

• Changes in brain metabolism

  MRS will be used

  MRS will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment

• Changes in brain plasticity

  Paired-pulse stimulation will be used

  Paired-pulse stimulation will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment

Secondary Outcomes (3)

• Influence on the quality of life

  Will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment

• influence on depression

  Will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment

• influence on nerve conduction

  this wil be controlled at baseline and 2 months after the last treatment.

Study Arms (2)

active rTMS

ACTIVE COMPARATOR

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

Device: rTMS

Sham rTMS

SHAM COMPARATOR

Sham stimulation will be delivered using a sham coil.

Device: Sham rTMS

Interventions

Sham rTMS DEVICE

sham rTMS

Sham rTMS

rTMS DEVICE

High-frequency rTMS

active rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

University hospital Brussels

Brussels, Jette, 1090, Belgium

Location

MeSH Terms

Conditions

Neuralgia; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: March 30, 2023
• Study Start: May 2, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 30, 2023

Record last verified: 2022-09

Locations

BE (1)