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

NCT07000214 | Recruiting Phase 2

• 1 other identifier: 010/2568
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Diabetic Polyneuropathy

Keywords

diabetic polyneuropathy; peripheral magnetic stimulation; balance training; physical performance; postural control

Outcome Measures

Primary Outcomes (1)

• One-leg standing balance test (OLST)

  Participants stand on the floor with their eyes open and arms relaxed at the sides of the body. They are instructed to lift the opposite foot off the floor, flex the knee to 90 degrees, and position the lifted foot behind the body, maintaining balance on the tested leg for as long as possible. The assessor begins timing when the participant's foot leaves the floor and stops timing if the participant sways, extends either arm to maintain balance, or successfully holds the position for 30 seconds. The test is then repeated on the opposite leg. The durations from both legs are summed and reported in seconds.

  From enrollment to the end of treatment (week 4).

Secondary Outcomes (3)

• Timed up and go test (TUGT)

  From enrollment to the end of treatment (week 4).

• Short physical performance battery (SPPB)

  From enrollment to the end of treatment (week 4).

• Nerve conduction study

  From enrollment to week 8.

Study Arms (2)

Peripheral magnetic stimulation with balance training (rPMS-BT)

EXPERIMENTAL

The participants will undergo a warm-up exercise involving ankle dorsiflexion, with concurrent rPMS applied to the tibialis anterior of each leg. Following the warm-up, participants will stand on the MAGBATA platform and perform one-leg stance exercises while rPMS is applied to the plantar surface of the foot. This procedure will be repeated for the other leg.

Device: Peripheral magnetic stimulation; Behavioral: Balance training

Sham stimulation with balance training (Sham-BT)

SHAM COMPARATOR

The sham comparator group will receive the same procedure as the interventional group, but with sham stimulation during both the warm-up and one-leg stance exercise.

Behavioral: Balance training; Other: Sham stimulation

Interventions

Peripheral magnetic stimulation DEVICE

During the warm-up exercise, 10-Hz rPMS will be applied to the tibialis anterior with an on-time of 4 seconds (40 pulses per train), followed by an off-time (inter-train interval) of 8 seconds, for a total of 25 trains for each leg. During the one-leg stance exercise, 20-Hz rPMS will be applied to the plantar surface of the standing foot for 3 seconds of on-time (60 pulses per train), followed by 12 seconds of off-time, for a total of 20 trains for each foot. Stimulation intensity will be set at 110% of MCT for the warm-up exercise and 120% of MCT for the treatment during the one-leg stance exercise.

Peripheral magnetic stimulation with balance training (rPMS-BT)

Balance training BEHAVIORAL

The warm-up exercise consists of 25 repetitions of 4-second active contractions of the tibialis anterior muscle in each leg while seated. Following the warm-up, participants will stand on the MAGBATA platform and perform 20 cycles of one-leg stance exercises under the supervision of a physiotherapist. Each cycle lasts 20 seconds, consisting of 3 seconds of one-leg stance while the other leg is raised about 10 centimeters above the ground, followed by 12 seconds of rest during which the participant stands on both legs, keeping their arms close to their body and hands free. The same sequence will then be repeated for the other leg. To prevent falling, participants will wear a safety belt around the waist, allowing the physiotherapist to assist if they lose balance. Participants will also be allowed to grab the walker positioned in front of them to prevent falling.

Peripheral magnetic stimulation with balance training (rPMS-BT); Sham stimulation with balance training (Sham-BT)

Sham stimulation OTHER

During the warm-up exercise, the stimulation coil will be placed perpendicular to the participants' shin. The same parameter settings will be used, except for the intensity, which will be set at 30% of the maximum stimulator output (MSO). Sham stimulation during the one-leg stance exercise is achieved by disconnecting the coil mounted in MAGBATA and placing an alternate coil, connected to the magnetic stimulator placed behind the participants so they can hear a clicking pattern similar to that of the rPMS-BT arm.

Sham stimulation with balance training (Sham-BT)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus type 2 with any symptoms of distal polyneuropathy, including numbness, paresthesia, dysesthesia, or lower leg weakness.
• Abnormal 10g monofilament test.
• Abnormal one-leg stance test (OLST) with eyes open.

You may not qualify if:

• Chronic foot ulceration.
• Severe leg or foot pain not controllable with medications or other interventions.
• Significant foot deformity, including severe pes cavus, severe claw toe, or toe amputation.
• Body mass index (BMI) over 35 kg/m².
• Visual acuity less than 20/100 after correction with glasses or contact lenses.
• Postural instability or coordination disorders resulting from musculoskeletal, vestibular, or central nervous system conditions.
• Symptoms such as confusion, drowsiness, dizziness, or a high risk of falls due to any disease or recent medication changes within a two-week period.
• Presence of cardiac pacemaker, knee prosthesis, or metal implants in the lower legs.
• Inability to walk or stand for at least 5 minutes.
• Inability to understand, comprehend, or follow instructions required to conduct the study, or to provide informed consent.

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead
• Chulalongkorn University: collaborator

Study Sites (1)

Queen Savang Vadhana Memorial Hospital

Chon Buri, Changwat Chon Buri, 20110, Thailand

RECRUITING

Related Publications (9)

• Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

  PMID: 8126356 BACKGROUND

• Himeno T, Kamiya H, Nakamura J. Lumos for the long trail: Strategies for clinical diagnosis and severity staging for diabetic polyneuropathy and future directions. J Diabetes Investig. 2020 Jan;11(1):5-16. doi: 10.1111/jdi.13173. Epub 2019 Dec 1.

  PMID: 31677343 BACKGROUND

• Xu S, Ito A, Zhao Z, Nakahara R, Tai C, Miyamoto F, Kuroki H, Aoyama T. Repetitive magnetic stimulation prevents dorsal root ganglion neuron death and enhances nerve regeneration in a sciatic nerve injury rat model. Sci Rep. 2024 Aug 16;14(1):19016. doi: 10.1038/s41598-024-69251-4.

  PMID: 39152157 BACKGROUND

• Yan T, Liang M, Peng J, Yu Q, Li Y, Yang J, Zhang S, Wang C. Cortical Mechanisms Underlying Effects of Repetitive Peripheral Magnetic Stimulation on Dynamic and Static Postural Control in Patients with Chronic Non-Specific Low Back Pain: A Double-Blind Randomized Clinical Trial. Pain Ther. 2024 Aug;13(4):953-970. doi: 10.1007/s40122-024-00613-6. Epub 2024 Jun 19.

  PMID: 38896200 BACKGROUND

• Alissa N, Shipper AG, Zilliox L, Westlake KP. A Systematic Review of the Effect of Physical Rehabilitation on Balance in People with Diabetic Peripheral Neuropathy Who are at Risk of Falling. Clin Interv Aging. 2024 Jul 19;19:1325-1339. doi: 10.2147/CIA.S459492. eCollection 2024.

  PMID: 39050517 BACKGROUND

• Baek J, Park N, Lee B, Jee S, Yang S, Kang S. Effects of Repetitive Peripheral Magnetic Stimulation Over Vastus Lateralis in Patients After Hip Replacement Surgery. Ann Rehabil Med. 2018 Feb;42(1):67-75. doi: 10.5535/arm.2018.42.1.67. Epub 2018 Feb 28.

  PMID: 29560326 BACKGROUND

• Smith S, Ravikumar R, Carvalho C, Normahani P, Lane T, Davies AH. Neuromuscular electrical stimulation for the treatment of diabetic sensorimotor polyneuropathy: A prospective, cohort, proof-of-concept study. Neurophysiol Clin. 2024 May;54(3):102943. doi: 10.1016/j.neucli.2024.102943. Epub 2024 Feb 29.

  PMID: 38422719 BACKGROUND

• Ahmad I, Noohu MM, Verma S, Singla D, Hussain ME. Effect of sensorimotor training on balance measures and proprioception among middle and older age adults with diabetic peripheral neuropathy. Gait Posture. 2019 Oct;74:114-120. doi: 10.1016/j.gaitpost.2019.08.018. Epub 2019 Aug 30.

  PMID: 31499405 BACKGROUND

• Dana E, Tran C, Osokin E, Westwood D, Moayedi M, Sabhaya P, Khan JS. Peripheral magnetic stimulation for chronic peripheral neuropathic pain: A systematic review and meta-analysis. Pain Pract. 2024 Apr;24(4):647-658. doi: 10.1111/papr.13332. Epub 2023 Dec 16.

  PMID: 38102884 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

KOMWUDH KONCHALARD, Doctor of Medicine

CONTACT

+6638320200; komwudh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiatrist, Department of Rehabilitation Medicine

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 2, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication; for 2 years.
• Access Criteria: IPD will be shared upon reasonable request by email with researchers conducting similar studies or performing meta-analyses. The process will require approval by the Institutional Review Board (IRB) and may also require a data use agreement.

Locations

TH (1)