Treatment for Diabetic Neuropathy Using Repetitive Transcranial Magnetic Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

NCT03625752

Diabetic Neuropathies Chronic Pain

ACTIVE_NOT_RECRUITING NA

tDCS and Pain Associated With Diabetic Neuropathy

NCT04306289

Diabetic Neuropathies Chronic Pain

UNKNOWN NA

Electrical Stimulation in Diabetic Peripheral Neuropathy

NCT02082145

NMES Control

COMPLETED NA

The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy

NCT04025320

Diabetic Neuropathy

COMPLETED NA

Eye Movement Desensitization and Reprocessing (EMDR) as a Treatment for Chronic Painful Diabetic Peripheral Neuropathy

NCT06171230

Neuropathic Pain Diabetes Mellitus

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Diabetic neuropathy (DN) is one of the most common complications of diabetes, occurring in \~50% of patients. DN results from damage to the peripheral and autonomic nervous systems. Due to the damage to small peripheral nerve fibers, patients often do not properly perceive local traumas because of the absence of pain perception and vibration perception. The upper and lower limbs are the most commonly affected areas among individuals with DN, putting patients at a higher risk of developing skin ulcerations and undergoing amputations. DN is characterized by various symptoms including numbness, loss of sensation, tingling, weakness, pain, unsteadiness, loss of vibration sense and abnormal temperature (often cold). DN is associated with decreased quality of life, depression, sleep disturbance and anxiety. It is currently managed by the control of blood glucose levels, medications to relieve pain and symptoms, physical therapy and lifestyle modifications. The global prevalence of DN is increasing, leading to a high incidence of lower limp amputations in the DN population, which accounts for approximately 70% of non-traumatic amputations worldwide. DN is also correlated with increased risk of cardiovascular disease and leads to an increase in mortality of diabetic patients. Therefore, it is crucial to find new ways to improve neuropathy in patients living with DN.

A novel approach to treating neuropathy is through the induction of neuroplasticity. Neuroplasticity refers to the ability of the brain to change, either through structural reorganization or functional changes in brain activation. Neuroplasticity can be induced non-invasively with a form of brain stimulation known as repetitive Transcranial Magnetic Stimulation (rTMS). rTMS involves an electromagnetic coil placed against the scalp that generates magnetic pulses to induce electric fields in the brain. By delivering these electric fields in rapid succession and at low intensity, functional changes in the brain (i.e. neuroplasticity) can be evoked. rTMS can be used to treat neurodegeneration, blood flow change, autonomic nervous disorders, depression, and vascular endothelial injury. rTMS can produce inhibitory or excitatory stimulation of the cerebral cortex or specific areas, leading to remodeling of the nervous system. This makes it a promising application for promoting nerve regeneration, neuroprotection, and localization of injuries. DN is closely related to cardiovascular disease as DN damages the autonomic nervous system (ANS), which controls heart rate (HR) and blood pressure (BP). With rTMS, this damage in ANS, specifically, HR and BP, can be improved. Inhibitory stimulation can lower HR while excitatory stimulation can enhance heart rate variability. Both inhibitory and excitatory stimulation can lower BP. Thus, the use of rTMS can improve a variety of functions that could prevent further complications and possibly improve neuropathy, as well.

Inflammation is a crucial factor in the progression of DN, as it involves an increase in chemokine production, inflammatory cell infiltration in the kidney, tissue damage, and production of pro-inflammatory cytokines. Infiltration of inflammatory cells into the kidney can lead to diabetic kidney disease, which is the most prevalent cause of terminal renal failure globally with suboptimal treatment options. Due to the close link between DN and inflammation, reducing inflammation has been suggested as a possible therapeutic option for this population. Additionally, diabetic wounds and inflammation are also associated, therefore controlling inflammation may improve wound management and healing rates. Researchers have recently discovered that rTMS can impact the levels of inflammatory markers (such as IL-1B, IL-6, IL-10, TNF-α, TGF-β, CRP, SP, and BDNF) in other conditions such as depression, post-stroke, and Alzheimer's. The study by Zhao et al. investigated the effects of 20 sessions of rTMS intervention on 29 individuals diagnosed with refractory depression. Significant increases in serum BDNF levels and decreases in IL-1β and TNF-α levels were noted after one week of intervention, compared to healthy individuals, and this trend continued over the 4-week stimulation period. However, there was no change noted in the sham group. Cha et al. conducted a post-stroke study measuring the effects of 10 sessions of rTMS intervention on 10 individuals with post-stroke cognitive impairment. Following the intervention, levels of IL-1β, IL-6, TNF-α, and TGF-β mRNA decreased. Velioglu et al. explored the effects of 10 sessions of rTMS intervention on 15 individuals with Alzheimer's Disease. An increase in BDNF levels was noted following the conclusion of the intervention. Although no studies have been done in the DN population, the use of rTMS to examine changes in these levels is promising.

The goal of the proposed research is to investigate the use of rTMS to improve the symptoms of neuropathy in patients living with diabetic neuropathy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Neuropathies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A (Sham)

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.

Group Type SHAM_COMPARATOR

Sham Repetitive transcranial magnetic stimulation

Intervention Type 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 B (Active)

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.

Group Type ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sham Repetitive transcranial magnetic stimulation

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.

Intervention Type DEVICE

Repetitive transcranial magnetic stimulation

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

rTMS, Repetitive TMS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A diagnosis of diabetic neuropathy

Exclusion Criteria

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No