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

Official title

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

Overview

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.

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.

Interventions

• Device Peripheral magnetic stimulation
  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
• Behavioral Balance training
  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 participa
• Other Sham stimulation
  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 o

Primary outcome measures

• One-leg standing balance test (OLST) [Time frame: From enrollment to the end of treatment (week 4).]

Secondary outcome measures (3)

• Timed up and go test (TUGT) [Time frame: From enrollment to the end of treatment (week 4).]
• Short physical performance battery (SPPB) [Time frame: From enrollment to the end of treatment (week 4).]
• Nerve conduction study [Time frame: From enrollment to week 8.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Thailand · 1 center

• Queen Savang Vadhana Memorial Hospital — Chon Buri

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 31499405

Identifiers

NCT: NCT07000214 · 010/2568

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗