Actively Recruiting

Phase 2
Age: 50Years - 75Years
All Genders
NCT07000214

Peripheral Magnetic Stimulation With Balance Training to Decrease Fall Risks in Diabetic Polyneuropathy

Led by Queen Savang Vadhana Memorial Hospital, Thailand · Updated on 2026-04-01

40

Participants Needed

1

Research Sites

59 weeks

Total Duration

On this page

Sponsors

Q

Queen Savang Vadhana Memorial Hospital, Thailand

Lead Sponsor

C

Chulalongkorn University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study aims to determine whether peripheral magnetic stimulation (PMS) during balance training in patients with diabetic polyneuropathy reduces fall risk, as measured by balance tests, and lessens disease severity compared to balance training with sham stimulation. This proof-of-concept study will utilize the Magnetic and Balance Training Activator (MAGBATA), a platform mounted with a magnetic stimulation coil that delivers electromagnetic pulses directly to the plantar surfaces of the feet while patients stand. A racetrack coil (RT-120), connected to the MagPro X100 magnetic stimulator with MagOption (MagVenture, Farum, Denmark), will be used. Parameters for the repetitive peripheral magnetic stimulation (rPMS) protocol will be configured to facilitate sensory input, enhance brain plasticity, and promote axonal regeneration.

CONDITIONS

Official Title

Peripheral Magnetic Stimulation With Balance Training to Decrease Fall Risks in Diabetic Polyneuropathy

Who Can Participate

Age: 50Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diabetes mellitus type 2 with symptoms of distal polyneuropathy such as numbness, paresthesia, dysesthesia, or lower leg weakness
  • Abnormal 10g monofilament test result
  • Abnormal one-leg stance test with eyes open
Not Eligible

You will not qualify if you...

  • Chronic foot ulceration
  • Severe leg or foot pain not controlled by medication or other treatments
  • Significant foot deformity including severe pes cavus, severe claw toe, or toe amputation
  • Body mass index over 35 kg/m2
  • Visual acuity less than 20/100 with correction
  • Postural instability or coordination problems due to musculoskeletal, vestibular, or central nervous system disorders
  • Symptoms like confusion, drowsiness, dizziness, or high fall risk due to illness or recent medication changes within two weeks
  • Presence of cardiac pacemaker, knee prosthesis, or metal implants in lower legs
  • Inability to walk or stand for at least 5 minutes
  • Inability to understand or follow study instructions or provide informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Queen Savang Vadhana Memorial Hospital

Chon Buri, Changwat Chon Buri, Thailand, 20110

Actively Recruiting

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Research Team

K

KOMWUDH KONCHALARD, Doctor of Medicine

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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