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New treatment option for Diabetic Polyneuropathy
Official title Peripheral Magnetic Stimulation With Balance Training to Decrease Fall Risks in Diabetic Polyneuropathy
ClinicalTrials.gov ID: NCT07000214
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75
You may be able to join 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 likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chon Buri, Changwat Chon Buri, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chon Buri, Changwat Chon Buri, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.