Treatment for Painful Diabetic Neuropathy

NCT05937984 | Unknown

• 1 other identifier: 16418
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Painful diabetic neuropathy (pDN) occurs in a subset of diabetic patients, and is characterize by burning, shooting, and electric shock-like pain in the arms and legs. This represents a major health crisis, given the increasing prevalence of pDN and the significant impact it has on quality of life. However, there is limited evidence of effective therapies for pDN pain relief. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive form of brain stimulation that may be a promising therapy for pDN. Previous research has shown that rTMS reduces neuropathic pain in pDN (1, 2, 3). While this is promising, it is important to note that rTMS is effective for \~50% of patients with neuropathic pain. (4, 5). Recent advancements in rTMS technology have created the opportunity for remarkable strides in the effectiveness of this potential therapy. This new development called controlled pulse parameter TMS (cTMS) increases the magnitude and longevity of TMS-induced effects. Although not tested in chronic pain, cTMS possess the power to make transformative changes in pDN, potentially yielding greater and widespread improvements in pain. The overarching goal of the proposed research is to assess the effects of a 5-day cTMS stimulation protocol on measures of pain and neurological function in individuals with pDN.

1. 1.Kwak S, Choi SG, Chang GS, \& Yang MC (2022). Short-term Effect of Repetitive Transcranial Magnetic Stimulation on Diabetic Peripheral Neuropathic Pain. Pain Physician, 25(2), E203-E209.
2. 2.Abdelkader AA, Gohary AME, Mourad HS, \& Salmawy DAE (2019). Repetitive tms in treatment of resistant diabetic neuropathic pain. Egyptian Journal of Neurology, Psychiatry and Neurosurgery, 55(1).
3. 3.Onesti E et al. (2013). H-coil repetitive transcranial magnetic stimulation for pain relief in patients with diabetic neuropathy. European Journal of Pain (United Kingdom), 17(9).
4. 4.Attal N et al. (2021). Repetitive transcranial magnetic stimulation for neuropathic pain: a randomized multicentre sham-controlled trial. Brain, 144(11).

Conditions

Painful Diabetic Neuropathy

Keywords

controlled transcranial magnetic stimulation; painful diabetic neuropathy; pain; neuroplasticity

Outcome Measures

Primary Outcomes (1)

• Change in PROMIS-29 v2.0 Profile

  Using numerical rating (0 to 5) to assess the change in 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).

  Day 1 of intervention, 24 hours post intervention, and 1 week post intervention

Secondary Outcomes (7)

• Number of responders to active cTMS

  Day 1 of intervention, 24 hours post intervention, and 1 week post intervention

• Change in Patient Perceived Global Index of Change (PGIC)

  Day 1 of intervention, 24 hours post intervention, and 1 week post intervention

• Change in Pain catastrophizing scale-EN-SF

  Day 1 of intervention, 24 hours post intervention, and 1 week post intervention

• Compliance of treatment sessions

  Day 1 of intervention, 24 hours post intervention, and 1 week post intervention

• Change in neurophysiological assessment

  Day 1 of intervention, 24 hours post intervention, and 1 week post intervention

Study Arms (2)

Active cTMS

ACTIVE COMPARATOR

Controlled Transcranial Magnetic Stimulation (cTMS) will be delivered at 10 Hz, 1500 pulses targeting the hand representation of the left primary motor cortex. cTMS delivery will require \~9 min to complete. This intervention will be performed approximately 5 days per week for 2 weeks. In addition, participants will experience their standard medical care.

Device: Active Controlled Transcranial Magnetic Stimulation (cTMS)

Sham cTMS

SHAM COMPARATOR

Sham cTMS will be delivered at as a placebo control. It is important to note that from the participant perspective, the sham stimulation will feel and sound identical to active cTMS. This will be performed approximately 5 days per week for 2 weeks. In addition, participants will experience their standard medical care.

Device: Sham Controlled Transcranial Magnetic Stimulation (cTMS)

Interventions

Active Controlled Transcranial Magnetic Stimulation (cTMS) DEVICE

cTMS 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. 1500 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 cTMS requires 9 minutes in total.

Active cTMS

Sham Controlled Transcranial Magnetic Stimulation (cTMS) DEVICE

A sham coil will be utilized for the sham cTMS condition. It is important to note that from the participant perspective, the sham stimulation will feel and sound identical to active. The location and all other parameters of Sham cTMS will be identical to Active cTMS.

Sham cTMS

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of painful diabetic neuropathy (pDN)

You may not qualify if:

• a known history of moderate to severe chronic pain other than pDN
• daily use of opioids prior to the pDN diagnosis
• contraindications to TMS
• known psychological diagnosis affecting comprehension and inability to participate in the study

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aimee Nelson, PhD

CONTACT

9055259140; nelsonaj@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: July 10, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 10, 2023

Record last verified: 2023-06

Locations

CA (1)