Painful Diabetic Neuropathy Clinical Trial
Official title:
Advanced Controlled Transcranial Magnetic Stimulation to Modulate Neuroplasticity and Alleviate Pain in Diabetic Neuropathy
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. 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. 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. 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. Attal N et al. (2021). Repetitive transcranial magnetic stimulation for neuropathic pain: a randomized multicentre sham-controlled trial. Brain, 144(11). 65. Dongyang L et al. (2021). Posterior-superior insular deep transcranial magnetic stimulation alleviates peripheral neuropathic pain - A pilot double-blind, randomized cross-over study. Neurophysiologie Clinique, 51(4).
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | Inclusion Criteria: - A diagnosis of painful diabetic neuropathy (pDN) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | St. Joseph's Healthcare Hamilton |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of responders to active cTMS | Defined as participants who experienced a reduction in NRS of at least 2 points at T1 or T4 | Day 1 of intervention, 24 hours post intervention, and 1 week post intervention | |
Secondary | Change in 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. | Day 1 of intervention, 24 hours post intervention, and 1 week post intervention | |
Secondary | Change in Pain catastrophizing scale-EN-SF | Will be used to assess the patients feeling and emotion related to their pain experience | Day 1 of intervention, 24 hours post intervention, and 1 week post intervention | |
Secondary | Compliance of treatment sessions | Compliance of sessions is defined as a minimum of attending 3 sessions per week for 2 weeks. | Day 1 of intervention, 24 hours post intervention, and 1 week post intervention | |
Secondary | Change in neurophysiological assessment | This will include assessments of Motor-evoked potentials (MEPs), short-intracortical inhibition (SICI), contralateral silent period (cSP) and motor maps obtained with single-pulse TMS (note: this form of TMS does not induce neuroplasticity like cTMS, but is instead used to assess the baseline excitability of the primary motor cortex) | Day 1 of intervention, 24 hours post intervention, and 1 week post intervention | |
Secondary | Change in quantitative sensory testing | Will be used in this study to assess somatosensory function to determine underlying pain mechanisms for pain phenotypes. QST will be used to measure detection thresholds for cold, warm, vibration, and mechanical stimuli. Pain thresholds will be assessed for cold, heat, mechanical, and pressure stimuli. In addition, allodynia will be measured. | Day 1 of intervention, 24 hours post intervention, and 1 week post intervention | |
Secondary | Change in nerve conduction assessments | Nerve conduction measures will be acquired from bilateral upper and lower limbs. These will include both motor (tibial and ulnar) and sensory nerves (superficial peroneal, sural, and ulnar). Nerve conduction outcomes will include latencies, amplitudes, and conduction velocities and F-waves for the aforementioned nerves. In addition to nerve conduction, participants with lower limb pDN will have Hoffman-reflex assessments performed on bilateral lower limb. For all participants, the maximum M-wave (M-Max) of the right APB muscle will be acquired. | Day 1 of intervention, 24 hours post intervention, and 1 week post intervention |
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