Effects of Functional Magnetic Stimulation in Sensory and Motor Function in Diabethic Neuropathy

NCT07818993 | Completed

• 1 other identifier: FMS_DPN
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated whether a 2-week course of functional magnetic stimulation applied to the plantar region of the foot could improve sensory function, foot muscle force, postural control, and functional mobility in adults with type 2 diabetes mellitus and diabetic peripheral neuropathy. Participants were assigned to active functional magnetic stimulation or sham stimulation. The study hypothesis was that repeated functional magnetic stimulation would improve sensory and motor function and lead to better functional performance compared with sham stimulation.

Conditions

Diabetic Peripheral Neuropathy

Keywords

functional magnetic stimulation; peripheral magnetic stimulation; plantar sensation; foot strength; diabetic peripheral neuropathy; vibration perception

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Timed Up and Go Completion Time

  Participants rose from a chair, walked 3.6 m, turned, walked back to the chair, and sat down. Completion time was recorded in seconds. Lower values indicate better functional mobility.

  Baseline and after 2 weeks of intervention (after 12 sessions)

• Change From Baseline in Hallux Grip Force Assessed With the Enhanced Paper Grip Test

  Hallux grip force was measured in Newtons using the Enhanced Paper Grip Test. Three measurements were performed for each foot, and the outcome was the average across both feet and three trials. Higher values indicate greater foot grip force.

  Baseline and after 2 weeks of intervention (after 12 sessions)

Secondary Outcomes (3)

• Change From Baseline in Center-of-Pressure Sway Velocity

  Baseline and after 2 weeks of intervention (after 12 sessions)

• Change From Baseline in Semmes-Weinstein Monofilament Total Score

  Baseline and after 2 weeks of intervention (after 12 sessions)

• Change From Baseline in Vibration Perception Threshold

  Baseline and after 2 weeks of intervention (after 12 sessions)

Study Arms (2)

Functional Magnetic Stimulation

EXPERIMENTAL

Participants received functional magnetic stimulation applied to the plantar region of the foot using the FMS Stym device. Treatment consisted of 12 sessions over 2 weeks, with each session lasting 20 minutes. The manufacturer's preset peripheral neuropathy program was used. Stimulation was continuous and intensity was individually adjusted to produce visible contractions of the intrinsic foot muscles while remaining comfortable.

Device: Functional Magnetic Stimulation

Sham Functional Magnetic Stimulation

SHAM COMPARATOR

Participants underwent the same positioning, treatment schedule, and session procedures as the active stimulation group. A metal plate was placed between the upper support plate and magnetic stimulation head to shield or substantially attenuate the magnetic field reaching the foot. Sessions lasted 20 minutes and were performed 12 times over 2 weeks.

Device: Sham Functional Magnetic Stimulation

Interventions

Functional Magnetic Stimulation DEVICE

Pulsed magnetic stimulation was delivered to the plantar region of the foot using the FMS Stym device (Iskra Medical, Slovenia). Participants completed 12 sessions over 2 weeks, each lasting 20 minute

Functional Magnetic Stimulation

Sham Functional Magnetic Stimulation DEVICE

Sham treatment reproduced the positioning, appearance, schedule, and duration of active functional magnetic stimulation while a metal plate substantially attenuated the magnetic field reaching the foo

Sham Functional Magnetic Stimulation

Eligibility Criteria

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

You may qualify if:

• Adults with type 2 diabetes mellitus and diabetic peripheral polyneuropathy documented in their medical records
• Ability to walk independently with or without an assistive device
• Ability to understand and follow study procedures

You may not qualify if:

• Conditions that could independently affect balance or foot function
• Contraindications to magnetic stimulation
• Active foot ulceration
• Recent lower-limb injury or surgery
• Severe neurological or musculoskeletal disease unrelated to diabetic peripheral neuropathy
• Cognitive impairment preventing valid participation

Sponsors & Collaborators

• University of Primorska: lead
• Zdravstevni dom Koper: collaborator

Study Sites (1)

Zdravstveni dom Koper

Koper, Urban Municipality of Koper, 6000, Slovenia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants in the sham group underwent the same positioning, session duration, and treatment procedures as participants receiving active stimulation. A metal plate was positioned between the support plate and magnetic stimulation head to shield or substantially attenuate the magnetic field while preserving the external appearance and procedural experience of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: September 24, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 25, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

SL (1)