Ignite Creation Date:
2024-07-17 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482827
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Treatment for Diabetic Neuropathy Using Repetitive Transcranial Magnetic Stimulation
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Effects of Repetitive Transcranial Magnetic Stimulation on Neuropathy in Diabetic Neuropathy A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 ie 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 Alzheimers 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 Alzheimers 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
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 ie 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 Alzheimers 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 Alzheimers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None