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Diabetic PolyneuropathyPhase 2NCT07000214

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

A Phase 2 study testing Peripheral magnetic stimulation and Balance training in people with Diabetic Polyneuropathy, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Diabetic Polyneuropathy
What is being tested?
Peripheral magnetic stimulation and Balance training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteThailand
Study dates
10 Jun 2025to 31 Aug 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

KOMWUDH KONCHALARD, Doctor of Medicine contact

+6638320200 ext. 10711

komwudh@gmail.com

Thailand1 site, 1 recruiting

  • Queen Savang Vadhana Memorial Hospital

    Chon Buri, Changwat Chon Buri, 20110

    Komwudh Konchalard, MD, +6638320200 ext. 10711, komwudh@gmail.com

    Recruiting

Other trials in Thailand

About this study

Official title: Peripheral Magnetic Stimulation With Balance Training to Decrease Fall Risks in Older Patients With Diabetic Polyneuropathy

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.

Read the detailed description

This single-center randomized controlled trial will use a two-group parallel design and include 40 patients with diabetic polyneuropathy who meet the eligibility criteria. Participants will be randomly assigned to either the active intervention group or the control group.

The active intervention group will receive a warm-up exercise consisting of 25 repetitions of ankle dorsiflexion with concurrent 10 Hz rPMS applied to the tibialis anterior of each leg. 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 and consists of 3 seconds of 20 Hz rPMS applied to the plantar surface of the foot while the participant stands on one leg, followed by 12 seconds of rest during which the participant stands on both legs. The same sequence will then be repeated for the other leg. Stimulation intensity will be determined prior to the warm-up. The coil will be placed over the tibialis anterior to determine the minimal contraction threshold (MCT), defined as the lowest intensity that produces a visible contraction. The stimulation intensity will be set at 110% of the MCT for the warm-up exercise and 120% for the treatment during balance exercises.

The control group will receive the same procedure, but with sham stimulation during both the warm-up and one-leg stance phases.

The intervention will consist of 8 sessions, conducted twice per week with at least one day of rest between sessions. Outcome assessments include one-leg stance test (OLST) with eyes open, timed up and go test (TUGT), and short physical performance battery (SPPB); these assessments will be conducted at baseline and after the 4-week intervention. Additionally, a rehabilitation physician, blinded to group allocation, will perform electrophysiologic studies at baseline and week 8 to assess disease severity. These studies will include bilateral measurements of sural nerve amplitude and conduction velocity, tibial compound motor action potential (CMAP) amplitude and conduction velocity, and tibial F-wave latency.

Being tested
Peripheral magnetic stimulation, Balance training, Sham stimulation
Keywords
diabetic polyneuropathy, peripheral magnetic stimulation, balance training, physical performance, postural control
Medical subject headings
Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peripheral magnetic stimulationDevice

    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.

  • Balance trainingBehavioural

    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.

  • Sham stimulationOther

    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.

Study groups in NCT07000214
Study groupRoleWhat they receive
Peripheral magnetic stimulation with balance training (rPMS-BT)ExperimentalThe 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.
Receives: Device: Peripheral magnetic stimulation; Behavioral: Balance training
Sham stimulation with balance training (Sham-BT)Sham comparatorThe 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.
Receives: Behavioral: Balance training; Other: Sham stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 each legs are reported in seconds.

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

Secondary outcomes (3)

  1. Timed up and go test (TUGT)

    Participants sit on a chair with a seat height between 44 and 47 cm, with their back resting against the backrest. The assessor instructs them to walk to a marked point 3 meters straight ahead and then return to sit on the chair. Timing begins when the participant's back leaves the backrest and stops when they return to the chair and their back touches the backrest. The test is performed twice, and the best performance with shorter duration in seconds, will be recorded.

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

  2. Short physical performance battery (SPPB)

    The Short Physical Performance Battery (SPPB) includes three subtests: gait speed, chair stand, and balance. Each test scored from 0 to 4and are summed up to give a total score ranging from 0 to 12.

    Gait speed: Participants are instructed to walk at their normal pace over a distance of 4 meters. The assessor times each trial from the start of walking until the participant reaches the end.

    Chair stand test: Participants are instructed to rise from a seated position to standing five times, keeping their arms crossed at chest level. The assessor starts timing when the participant's buttocks leave the chair and stops when they return to the seat after the fifth stand.

    Balance test on both feet: Participants first stand with feet together for 10 seconds to earn 1 point, then in semi-tandem with the heel beside the mid-foot for 10 seconds to earn another point, and finally in full tandem for 10 seconds to earn 2 points.

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

  3. Nerve conduction study

    Nerve conduction study will be performed using the electrodiagnostic unit, Sierra Summit (Cadwell, Kennewick, WA, USA). Bilateral sural and tibial nerves will be tested, measuring parameters including sensory nerve action potential (SNAP) amplitude of the sural nerves, compound motor action potential (CMAP) amplitudes of the tibial nerves, F-wave latency of the tibial nerves. The parameters of each legs are reported separately.

    Measured: From enrollment to week 8.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2025
  2. Study start10 Jun 2025
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07000214
Sponsor's protocol ID
010/2568
Status last verified
Aug 2026
First submitted
29 May 2025
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual-level data related to the primary and secondary outcomes of all participants will be shared.

Publications

  • 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.

    PubMed 8126356

  • 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.

    PubMed 31677343

  • 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.

    PubMed 39152157

  • 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.

    PubMed 38896200

  • 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.

    PubMed 39050517

  • 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.

    PubMed 29560326

  • 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.

    PubMed 38422719

  • 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.

    PubMed 31499405

  • 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.

    PubMed 38102884

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Peripheral magnetic stimulation and Balance training in people with Diabetic Polyneuropathy, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact KOMWUDH KONCHALARD, Doctor of Medicine (+6638320200 ext. 10711, komwudh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

One-leg standing balance test (OLST) (time frame: From enrollment to the end of treatment (week 4).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07000214, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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