Peripheral magnetic stimulation plus balance training to reduce falls in diabetic polyneuropathy
Peripheral Magnetic Stimulation With Balance Training to Decrease Fall Risks in Older Patients With Diabetic Polyneuropathy
This trial will test whether adding peripheral magnetic stimulation to balance training helps people with diabetic polyneuropathy reduce their risk of falling.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Queen Savang Vadhana Memorial Hospital, Thailand Academic / other |
| Locations | 1 site (Chon Buri, Changwat Chon Buri) |
| Trial ID | NCT07000214 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized, parallel-group proof-of-concept trial will enroll 40 people with diabetic polyneuropathy who have abnormal monofilament and one-leg-stance tests. Participants are randomly assigned to active repetitive peripheral magnetic stimulation (rPMS) delivered via the MAGBATA platform and racetrack coil during supervised balance exercises or to a sham stimulation control with identical procedures. The active protocol includes a tibialis anterior warm-up with 10 Hz rPMS and repeated one-leg stance cycles with brief 20 Hz rPMS pulses applied to the plantar surface at individualized intensities set relative to each participant's minimal contraction threshold. The intervention consists of eight supervised sessions given twice weekly and compares balance test outcomes and neuropathy severity between groups.
Who should consider this trial
Good fit: Ideal candidates are adults with type 2 diabetes and symptomatic distal polyneuropathy who have abnormal 10 g monofilament and one-leg-stance tests and can stand and participate in supervised balance exercises.
Not a fit: Patients with chronic foot ulcers, severe foot deformity or amputation, uncontrolled severe leg pain, implanted pacemakers or metal in the lower legs, inability to stand or walk, or major non-neuropathic causes of postural instability are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could lower fall risk and improve balance and sensory function for people with diabetic polyneuropathy.
How similar studies have performed: The use of peripheral magnetic stimulation for sensory modulation and balance is relatively novel; small physiologic and pilot studies suggest potential benefit but high-quality randomized evidence in diabetic polyneuropathy is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chon Buri, Changwat Chon Buri
- Queen Savang Vadhana Memorial Hospital — Chon Buri, Changwat Chon Buri, Thailand (Recruiting)
Study contacts
- Study coordinator: KOMWUDH KONCHALARD, Doctor of Medicine
- Email: komwudh@gmail.com
- Phone: +6638320200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.