TCMS for the Treatment of Foot Pain Caused By Diabetic Neuropathy

TransCutaneous Magnetic Stimulation (TCMS) for the Treatment of Foot Pain Caused By Diabetic Neuropathy

The study will evaluate whether an experimental medical device that emits a series of brief, intense magnetic pulse will relieve foot pain from Diabetic Neuropathy (DN). The United States Food and Drug Administration (FDA) has approved a similar device for treatment of migraine headaches, but this type of device has not been studied for the treatment of DN.

Study Overview

• Status: Completed
• Conditions: Diabetic Neuropathies
• Intervention / Treatment: Device: TransCutaneous Magnetic Stimulator (TCMS)

Detailed Description

The study will evaluate whether an experimental medical device that emits a series of brief, intense magnetic pulse will relieve foot pain from Diabetic Neuropathy (DN). The United States Food and Drug Administration (FDA) has approved a similar device for treatment of migraine headaches, but this type of device has not been studied for the treatment of DN. No significant adverse reactions or side effects have been reported from the use of magnetic stimulation for the headache treatment. Some patients who have migraine headaches have excellent pain relief with the magnetic treatment even if they did not get pain relief using medications.

The investigators do not know whether this magnetic treatment will relieve the foot pain caused by diabetic neuropathy, so they will test this by applying 50 strong magnet pulses to the painful area of each foot. This procedure will be repeated onto three parts of each foot. First onto the bottom of the foot, then the top of the foot and then the back of the foot including a portion of the ankle. The effect on pain in each foot while walking for about 10 steps will be recorded before the study begins and periodically for 28 days. This testing will provide data as to any improvement in pain relief. If the participants' reported pain is reduced as a result of the magnetic treatment, then the magnetic pulses will have shown that they have reduced the pain. Additional studies will be needed to further investigate this treatment and to determine how to obtain statistically significant data as to whether this therapy reduces the foot pain caused by diabetic neuropathy.

One side effect of this treatment may be some muscular jerking of the foot or the leg during the application of the magnetic pulses. This jerking will last only during the treatment and will not be painful or harmful.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Center for Diabetes and Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18 years of age.
2. Prescription pharmacologic treatment is insufficient for treatment of pain.
3. Pain duration of more than one months.
4. Pain occurs daily.
5. Chronic DN associated pain that is located in bilateral feet and is not explained by a central anatomic nerve compression and can clearly be correlated with that patient's history of diabetes.
6. Pain intensity ≥ 5 in each foot at the time of enrollment.

Exclusion Criteria:

1. Life expectancy ≤ 6 months.
2. Oral pain medication doses or active ingredient has changed significantly in the prior 2 weeks.
3. Inability to walk at least 10 steps (with or without a cane) before and after having to sit in a chair.
4. Another pain condition that might confound results (e.g., neuropathy from cancer chemotherapy).
5. Inability to undergo study assessments or complete questionnaires independently.
6. Active psychological co-morbidities (i.e., uncontrolled schizophrenia)
7. Currently using an opioid medication for the treatment of foot pain.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment group	Device: TransCutaneous Magnetic Stimulator (TCMS); TCMS coils which are connected to feet and pulse generator. The generator will then be turned on to deliver 50 pulses at a pulse period of 6 seconds and at a pulse intensity of 100% to the bottom of the foot with the TCMS coil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Numeric Pain Rating Scale, 0-10 with 0 being no pain, and 10 being worst pain ever experienced	1 to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status and Patient satisfaction with treatment	Descriptive Questionnaire to asses whether participant has improved functional status, such as ability to walk and whether participant is satisfied with treatment	1 to 28 days
Changes in pain medication	Assessment of pain medications taken by participant prior to treatment and 28 days after treatment to deteremine if any of pain medications were increased, decreased or eliminated after treatment	1 to 28 days

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Kashif Munir, M.D., University of Maryland School of Medicine

Publications and helpful links

General Publications

• Rao VP, Satyarengga M, Lamos EM, Munir KM. The Use of Transcutaneous Magnetic Stimulation to Treat Painful Diabetic Neuropathy. J Diabetes Sci Technol. 2021 Nov;15(6):1406-1407. doi: 10.1177/19322968211026943. Epub 2021 Jul 3. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): July 30, 2019

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (ACTUAL): July 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: HP-00081137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes