NCT07000214 Peripheral Magnetic Stimulation With Balance Training to Decrease Fall Risks in Diabetic Polyneuropathy
| NCT ID | NCT07000214 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Queen Savang Vadhana Memorial Hospital, Thailand |
| Condition | Diabetic Polyneuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2025-06-10 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07000214 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 75 Years, studying Diabetic Polyneuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07000214 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07000214 currently recruiting?
Yes, NCT07000214 is actively recruiting participants. Contact the research team at komwudh@gmail.com for enrollment information.
Where is the NCT07000214 trial being conducted?
This trial is being conducted at Chon Buri, Thailand.
Who is sponsoring the NCT07000214 clinical trial?
NCT07000214 is sponsored by Queen Savang Vadhana Memorial Hospital, Thailand. The trial plans to enroll 40 participants.