Treatment for Diabetic Neuropathy Using Repetitive Transcranial Magnetic Stimulation

NCT06482827 | Not Yet Recruiting

• 1 other identifier: 17797
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine whether a 4-week treatment of repetitive transcranial magnetic stimulation (rTMS) can alleviate the symptoms of neuropathy in individuals with diabetic neuropathy. The study will involve using questionnaires, nerve assessments, sensory tests, blood flow measurements, and blood tests to monitor any changes in symptoms after the rTMS intervention.

Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (4)

• Modified Toronto Clinical Neuropathy Score

  Will be used to assess the presence and severity of diabetic neuropathy ('yes' or 'no')

  Immediately before intervention, immediately following intervention, 4 weeks after intervention

• PROMIS-29 v2.0 Profile

  Using numerical rating (0 to 5) to assess seven health domains including physical function, anxiety, depression, fatigue, sleep disturbances, ability to participate in social roles and activities, and pain interference. Each category consists of 4 questions. Also uses a numerical rating to asses pain intensity (0-10).

  Immediately before intervention, immediately following intervention, 4 weeks after intervention

• Patient Perceived Global Index of Change (PGIC)

  1-7 Likert Scale: Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse

  Immediately following intervention, 4 weeks after intervention

• Pain catastrophizing scale-EN-SF

  Will be used to assess the patients feeling and emotion related to their pain experience

  Immediately before intervention, immediately following intervention, 4 weeks after intervention

Secondary Outcomes (5)

• Change in quantitative sensory testing

  Immediately before intervention, immediately following intervention, 4 weeks after intervention

• Change in nerve conduction assessments

  Immediately before intervention, immediately following intervention

• Change in blood flow

  Immediately before intervention, immediately following intervention

• Changes in wound

  Immediately before intervention, immediately following intervention

• Change in inflammation markers (IL-1B, IL-6, IL-10, TNF-α, TGF-β, CRP, SP, and BDNF)

  Immediately before intervention, immediately following intervention

Study Arms (2)

Group A (Sham)

SHAM COMPARATOR

Participants in group A will take part in 4 weeks of treatment with 5 sessions per week. Each session will involve sham repetitive transcranial magnetic stimulation (rTMS). Sham rTMS will be delivered at 10 Hz, 2004 pulses targeting the leg representation of the primary motor cortex. Participants will hear and experience the clicking but will not be provided with any stimulation. Sham rTMS will take approximately 11.5 minutes.

Device: Sham Repetitive transcranial magnetic stimulation

Group B (Active)

ACTIVE COMPARATOR

Participants in group B will take part in 4 weeks of treatment with 5 sessions per week. Each session will involve real repetitive transcranial magnetic stimulation (rTMS). rTMS will be delivered at 10 Hz, 2004 pulses targeting the leg representation of the primary motor cortex. rTMS will take approximately 11.5 minutes.

Device: Repetitive transcranial magnetic stimulation

Interventions

Sham Repetitive transcranial magnetic stimulation DEVICE

Sham repetitive transcranial magnetic stimulation (rTMS) is a non-invasive, non-painful procedure. The abductor pollicis brevis (APB) muscle of the left motor cortex will be targeted using neuronavigation software. During the sham, participants will hear and experience the clicking from the device but will not be provided with any stimulation. The delivery of sham rTMS requires \~ 11.5 minutes in total.

Group A (Sham)

Repetitive transcranial magnetic stimulation DEVICE

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive, non-painful procedure used to relieve chronic pain and promote short-term changes. The abductor pollicis brevis (APB) muscle of the left motor cortex will be targeted using neuronavigation software. 2004 pulses will be delivered at 10 Hz stimulation. Stimulation will be delivered at 80% of the resting motor threshold obtained from the right APB muscle. The delivery of rTMS requires \~ 11.5 minutes in total.

Also known as: rTMS, Repetitive TMS

Group B (Active)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of diabetic neuropathy

You may not qualify if:

• Contraindications to transcranial magnetic stimulation
• Known psychological diagnosis affecting comprehension
• Inability to participate in the study

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4L1, Canada

Location

Related Links

• Ader, D. N. (2007). Developing the Patient-Reported Outcomes Measurement Information System (PROMIS). Medical Care, 45(5), S1.
• Bondar, A. C., \& Popa, A. R. (2018). Diabetic Neuropathy Prevalence and Its Associated Risk Factors in Two Representative Groups of Type 1 and Type 2 Diabetes Mellitus Patients from Bihor County. Mædica, 13(3), 229-234.
• Callaghan, B., Kerber, K., Langa, K. M., Banerjee, M., Rodgers, A., McCammon, R., Burke, J., \& Feldman, E. (2015). Longitudinal patient-oriented outcomes in neuropathy. Neurology, 85(1), 71-79.
• Cha, B. et al. (2022). Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation for Post-stroke Vascular Cognitive Impairment: A Prospective Pilot Study. Frontiers in Neurology, 13.
• Defrin, R et al. (2007). The effect of a series of repetitive transcranial magnetic stimulations of the motor cortex on central pain after spinal cord injury. Archives of Physical Medicine and Rehabilitation, 88(12), 1574-1580.
• Duran-Salgado, M. B., \& Rubio-Guerra, A. F. (2014). Diabetic nephropathy and inflammation. World Journal of Diabetes, 5(3), 393-398.
• Feldman, E. L., Callaghan, B. C., Pop-Busui, R., Zochodne, D. W., Wright, D. E., Bennett, D. L., Bril, V., Russell, J. W., \& Viswanathan, V. (2019). Diabetic neuropathy. Nature Reviews. Disease Primers, 5(1), 42.
• Ferguson, L., \& Scheman, J. (2009). Patient global impression of change scores within the context of a chronic pain rehabilitation program. The Journal of Pain, 10(4), S73.
• Foglia, S. D. et al. (2022). Case report: The feasibility of rTMS with intrathecal baclofen pump for the treatment of unresolved neuropathic pain following spinal cord injury. Frontiers in Rehabilitation Sciences, 3, 893014.
• Hallett, M. (2007). Transcranial Magnetic Stimulation: A Primer. Neuron, 55(2), 187-199
• Juster-Switlyk, K., \& Smith, A. G. (2016). Updates in diabetic peripheral neuropathy. F1000Research, 5, F1000 Faculty Rev-738.
• Kang, B. S., Shin, H. I., \& Bang, M. S. (2009). Effect of repetitive transcranial magnetic stimulation over the hand motor cortical area on central pain after spinal cord injury. Archives of Physical Medicine and Rehabilitation, 90(10), 1766-1771.
• Lee, H., Lee, J. H., Hwang, M.-H., \& Kang, N. (2023). Repetitive transcranial magnetic stimulation improves cardiovascular autonomic nervous system control: A meta-analysis. Journal of Affective Disorders, 339, 443-453.
• Lim, A. K. H., \& Tesch, G. H. (2012). Inflammation in Diabetic Nephropathy. Mediators of Inflammation, 2012(1), 146154.
• Pop-Busui, R., Ang, L., Holmes, C., Gallagher, K., \& Feldman, E. L. (2016). Inflammation as a Therapeutic Target for Diabetic Neuropathies. Current Diabetes Reports, 16(3), 29.
• Sieberg, C. B., Taras, C., Gomaa, A., Nickerson, C., Wong, C., Ward, C., Baskozos, G., Bennett, D. L. H., Ramirez, J. D., Themistocleous, A. C., Rice, A. S. C., Shillo, P. R., Tesfaye, S., Edwards, R. R., Andrews, N. A., Berde, C., \& Costigan, M. (2018).
• Vinik, A. I., Erbas, T., \& Casellini, C. M. (2013). Diabetic cardiac autonomic neuropathy, inflammation and cardiovascular disease. Journal of Diabetes Investigation, 4(1), 4-18.
• Xu, X., \& Xu, D.-S. (2021). Prospects for the application of transcranial magnetic stimulation in diabetic neuropathy. Neural Regeneration Research, 16, 955.
• Yang, S., Kwak, S. G., Choi, G.-S., \& Chang, M. C. (2022). Short-term Effect of Repetitive Transcranial Magnetic Stimulation on Diabetic Peripheral Neuropathic Pain. Pain Physician, 25(2), E203-E209.

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Aimee Nelson, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aimee Nelson, PhD

CONTACT

9055259140; nelsonaj@mcmaster.ca

Jiyeon Park, BSc

CONTACT

2899523710; parkj103@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 1, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

CA (1)