Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468189
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-03-04
Brief Title:
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Sponsor:
Istanbul Medipol University Hospital
Organization:
Istanbul Medipol University Hospital
Study Overview
Official Title:
Clinical and Neurophysiological Effects of Simultaneous Application of tDCS to Visual and Motor Cortex in Migraine Double Blind Randomized Controlled Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
tDCS can be offered as an alternative to migraine patients who have frequent and severe attacks and who are resistant to or unresponsive to preventive drug therapy Additionally this technique may also be an option for patients who refuse or have contraindications to taking anti-migraine medications A decrease in headache severity and frequency is expected with this neuromodulation applied to migraine patients with frequent attacks Based on this hypothesis This tested whether simultaneous modulation of motor M1 left and visual cortex O1 or O2 ipsilateral with tDCS applied for 3 consecutive days is an effective treatment for migraine patients for the following specific purposes No significant undesirable effects are expected except for possible side effects that are simple and do not require medical intervention such as tingling or itching in the area where the electrodes are attached moderate fatigue mild headache nausea at a rate of less than 3 and insomnia at a rate of less than 1 The research will be conducted within the framework of ethical principles and in accordance with the good clinical practice protocol
A The primary purpose of this study is to determine whether transcranial direct current stimulation applied simultaneously to the motor and visual cortex in migraine patients provides a significant reduction in pain due to migraine attacks compared to sham tDCS Additionally to evaluate the effects of this treatment They will be measured changes in the number of migraine attacks abortive medication intake eg opioids triptans as well as overall improvement in cognitive status and quality of life In addition electrophysiological EEG evaluations before and after treatment and the results of these measurements as a potential biomarker in migraine will be compared in the active and sham groups
B It is aimed to determine whether the clinical effects of tDCS are long-lasting Therefore It will compared whether there is a difference in improvement of migraine-related pain between active and sham tDCS at pre-treatment baseline assessments as well as at 1 2 and 3 months after treatment
C Finally it will be examined whether tDCS treatment applied for 3 consecutive days in migraine patients is safe Safety will be evaluated through neuropsychological testing and adverse event reporting
A The primary purpose of this study is to determine whether transcranial direct current stimulation applied simultaneously to the motor and visual cortex in migraine patients provides a significant reduction in pain due to migraine attacks compared to sham tDCS Additionally to evaluate the effects of this treatment They will be measured changes in the number of migraine attacks abortive medication intake eg opioids triptans as well as overall improvement in cognitive status and quality of life In addition electrophysiological EEG evaluations before and after treatment and the results of these measurements as a potential biomarker in migraine will be compared in the active and sham groups
B It is aimed to determine whether the clinical effects of tDCS are long-lasting Therefore It will compared whether there is a difference in improvement of migraine-related pain between active and sham tDCS at pre-treatment baseline assessments as well as at 1 2 and 3 months after treatment
C Finally it will be examined whether tDCS treatment applied for 3 consecutive days in migraine patients is safe Safety will be evaluated through neuropsychological testing and adverse event reporting
Detailed Description:
Headache disorders are quite common In the 2016 Global Burden of Disease Study migraine was the second highest cause of disability overall and the most common disease causing disability in young adults 15-49 years When there are frequent or severe migraine attacks pharmacological agents are used to reduce the frequency of migraine attacks Standard migraine prophylactic treatments show either low efficacy or undesirable side effects and most of them are licensed for other diseases and not for migraine Additionally some migraine patients are hesitant to choose pharmacological treatment Compliance with these treatments is also quite low in the medication-using group Recently used calcitonin gene-related peptide CGRP monoclonal antibody treatments are quite expensive treatments Therefore there remains a need for an effective tolerable and affordable prophylactic treatment for migraine
Migraine is complex involving several circuits of both the central and peripheral nervous system and has a still unclear pathophysiology Trigeminovascular activation is the key event of migraine pain mostly related to the peripheral nervous system but the central nervous system also plays a role in the formation and perception of migraine The cerebral cortex of migraineurs is hypersensitive overexcitable to external stimuli possibly due to altered functional connectivity in subcortical structures including the thalamus This resulting thalamo-cortical dysrhythmia and changes in excitability can be controlled with non-invasive neuromodulation techniques such as transcranial magnetic stimulation TMS and transcranial direct current stimulation tDCS
Non-invasive neuromodulation is applied to various forms of primary headaches and is recommended as an easily applicable method for both episodic and chronic migraine So far only single pulse transcranial magnetic stimulation sTMS vagus nerve stimulation VNS and supraorbital neurostimulation have been approved by the FDA for the treatment of migraine Transcranial direct current stimulation tDCS direct current stimulation is an electrical stimulation method used for non-invasive brain stimulation where a weak electrical current of approximately 2 milliamps is applied through two scalp electrodes with a portable battery-powered system tDCS is an electrical stimulation technique in which low-amplitude direct current is applied to the skull via surface electrodes thereby modulating neural brain activity The applied current changes the transmembrane neuronal potential and thus affects the level of excitability Depending on the polarity of the active electrodes tDCS can increase or decrease cortical excitability tDCS has been shown to trigger changes in neuropsychological and motor activity in the brain Protocols with variable session numbers 1-20 days applied to different targeted brain regions provide promising results in pain syndromes by regulating pain-related pathways in various ways Stimulation of the motor cortex with tDCS has already been shown to relieve pain in patients with traumatic spinal cord injury and other chronic pain syndromes including fibromyalgia Migraine patients are often hypersensitive to pain A treatment that targets areas of the brain involved in the experience of pain may also help reduce pain in migraine patients According to the results of systematic review and meta-analysis of studies conducted so far tDCS has been evaluated as an effective reliable method that can improve migraine symptoms by activating the motor cortex or activatinginhibiting the visual cortex Additionally tDCS treatment repeated for days over a period of 4 weeks or longer is effective in reducing migraine pain severity and attack duration The benefit of tDCS may persist for at least 4 weeks after completion of the last tDCS session Both anodal and cathodal stimulation have been evaluated as effective for reducing migraine pain severity The study protocol present here aims to test a unique protocol with simultaneous anodal stimulation to the motor area and cathodal stimulation to the visual cortex In the meta-analyses conducted so far In future clinical studies using tDCS in migraine the importance of simultaneously measuring neuronal activity using EEG or fMRIFunctional magnetic resonance imaging is also emphasized in order to better understand the underlying mechanisms of action Electrophysiological techniques such as quantitative electroencephalography qEEG provide important information about brain functioning at rest and during sensory stimulation A large amount of data has demonstrated the presence of some excitability changes in the occipital cortex during the interictal period of migraine patientsWhile some studies have demonstrated hyperexcitability only a few studies have been able to document a decrease in occipital excitability This increase in occipital excitability has recently been recognized as an inhibition phenomenon and a new term hyperresponsiveness in migraine has come into use in the last decade This hyperexcitability has been demonstrated in many neurophysiological and neuroimaging studies as loss of habituation to recurrent stimuli Clearly spectral analysis of different frequency bands of qEEG helps us understand the intrinsic activity of the migraineur brain Differences in peak latency amplitude and synchronization of EEG frequency bands in response to sensory stimulation have been reported in migraine patients compared with healthy subjects In this study it is planned to make comparative evaluations in the following months with EEG recordings to be taken before and after simultaneous motor cortex and visual cortex stimulation In this way the relationship between anodal and cathodal transcranial direct current stimulation and different frequency bands in the occipital region will be determined by comparing the active treatment and sham groups
Review studies and recent studies from our country have shown that tDCS treatment is an effective and safe prophylactic treatment in migraine patients with allodynia in both short and long-term follow-ups In order to obtain better clinical evidence in this field as emphasized in the Cochrane analysis conducted in 2018 Randomized controlled studies with larger samples and clinically meaningful long-term results are needed In these studies it is planned to test the clinical effect of a protocol combination which has been shown to be particularly effective in prophylaxis in migraine patients in a large sample group while also evaluating its neurophysiological responses in active and sham groups
Migraine is complex involving several circuits of both the central and peripheral nervous system and has a still unclear pathophysiology Trigeminovascular activation is the key event of migraine pain mostly related to the peripheral nervous system but the central nervous system also plays a role in the formation and perception of migraine The cerebral cortex of migraineurs is hypersensitive overexcitable to external stimuli possibly due to altered functional connectivity in subcortical structures including the thalamus This resulting thalamo-cortical dysrhythmia and changes in excitability can be controlled with non-invasive neuromodulation techniques such as transcranial magnetic stimulation TMS and transcranial direct current stimulation tDCS
Non-invasive neuromodulation is applied to various forms of primary headaches and is recommended as an easily applicable method for both episodic and chronic migraine So far only single pulse transcranial magnetic stimulation sTMS vagus nerve stimulation VNS and supraorbital neurostimulation have been approved by the FDA for the treatment of migraine Transcranial direct current stimulation tDCS direct current stimulation is an electrical stimulation method used for non-invasive brain stimulation where a weak electrical current of approximately 2 milliamps is applied through two scalp electrodes with a portable battery-powered system tDCS is an electrical stimulation technique in which low-amplitude direct current is applied to the skull via surface electrodes thereby modulating neural brain activity The applied current changes the transmembrane neuronal potential and thus affects the level of excitability Depending on the polarity of the active electrodes tDCS can increase or decrease cortical excitability tDCS has been shown to trigger changes in neuropsychological and motor activity in the brain Protocols with variable session numbers 1-20 days applied to different targeted brain regions provide promising results in pain syndromes by regulating pain-related pathways in various ways Stimulation of the motor cortex with tDCS has already been shown to relieve pain in patients with traumatic spinal cord injury and other chronic pain syndromes including fibromyalgia Migraine patients are often hypersensitive to pain A treatment that targets areas of the brain involved in the experience of pain may also help reduce pain in migraine patients According to the results of systematic review and meta-analysis of studies conducted so far tDCS has been evaluated as an effective reliable method that can improve migraine symptoms by activating the motor cortex or activatinginhibiting the visual cortex Additionally tDCS treatment repeated for days over a period of 4 weeks or longer is effective in reducing migraine pain severity and attack duration The benefit of tDCS may persist for at least 4 weeks after completion of the last tDCS session Both anodal and cathodal stimulation have been evaluated as effective for reducing migraine pain severity The study protocol present here aims to test a unique protocol with simultaneous anodal stimulation to the motor area and cathodal stimulation to the visual cortex In the meta-analyses conducted so far In future clinical studies using tDCS in migraine the importance of simultaneously measuring neuronal activity using EEG or fMRIFunctional magnetic resonance imaging is also emphasized in order to better understand the underlying mechanisms of action Electrophysiological techniques such as quantitative electroencephalography qEEG provide important information about brain functioning at rest and during sensory stimulation A large amount of data has demonstrated the presence of some excitability changes in the occipital cortex during the interictal period of migraine patientsWhile some studies have demonstrated hyperexcitability only a few studies have been able to document a decrease in occipital excitability This increase in occipital excitability has recently been recognized as an inhibition phenomenon and a new term hyperresponsiveness in migraine has come into use in the last decade This hyperexcitability has been demonstrated in many neurophysiological and neuroimaging studies as loss of habituation to recurrent stimuli Clearly spectral analysis of different frequency bands of qEEG helps us understand the intrinsic activity of the migraineur brain Differences in peak latency amplitude and synchronization of EEG frequency bands in response to sensory stimulation have been reported in migraine patients compared with healthy subjects In this study it is planned to make comparative evaluations in the following months with EEG recordings to be taken before and after simultaneous motor cortex and visual cortex stimulation In this way the relationship between anodal and cathodal transcranial direct current stimulation and different frequency bands in the occipital region will be determined by comparing the active treatment and sham groups
Review studies and recent studies from our country have shown that tDCS treatment is an effective and safe prophylactic treatment in migraine patients with allodynia in both short and long-term follow-ups In order to obtain better clinical evidence in this field as emphasized in the Cochrane analysis conducted in 2018 Randomized controlled studies with larger samples and clinically meaningful long-term results are needed In these studies it is planned to test the clinical effect of a protocol combination which has been shown to be particularly effective in prophylaxis in migraine patients in a large sample group while also evaluating its neurophysiological responses in active and sham groups
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?:
False
Is an FDA AA801 Violation?:
None