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| Name | Class |
|---|---|
| University of Sao Paulo | OTHER |
| Coordination for the Improvement of Higher Education Personnel | OTHER |
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The aim of this study is to analyse whether there is an advantage in adding low-intensity electrical stimulations to the vagus nerve with electrodes in the outer ear to control pain and fatigue in people with primary chronic pain, and in people who have had COVID-19. Several studies have shown that many people with primary chronic pain and also people who have had COVID patients continue to have pain and fatigue that may be due to changes that occur in the brain and the vagus nerve that passes through the neck might cause inflammation. Therefore the aim of this study is to investigate if these electrical stimulations can help improve the condition of the brain and nerve and consequently, the inflammation so that these complaints improve.
This study will be organized as the following: It will begin with an assessment, divided into a part with questionnaires and another with specific tests. The questionnaires are aimed at understanding volunteer's characteristics, pain, fatigue, inflammation, sleep, quality of life, and the presence of symptoms of anxiety and depression. Next, the volunteer will undergo two tests to assess the behavior of his/her brain. They are performed using EEG electroencephalography and transcranial magnetic stimulation (TMS).
After the assessments, volunteers will be randomly selected to receive neuromodulation sessions using low-intensity electrical stimulation of the vagus nerve, using electrodes in the outer ear (active group), or sessions that only simulate this neuromodulation (sham, or placebo, group). This will occur for five consecutive days, starting on the day of the assessment. This stimulation is very weak and may not even be felt by the person receiving it. This technique is safe and the most that may occur is redness or itching of the skin. A few people may also experience tingling, a burning sensation or momentary local pain, fatigue, drowsiness, difficulty concentrating and a feeling of nervousness during or after the stimulation.
At the end of the 5 days of electrical stimulation, the same initial assessments will be repeated to see if anything has changed in the volunteer's brain, heart rate, blood pressure, pain, fatigue, inflammation, sleep, quality of life, depression, and anxiety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects | Other | Once a week, each subject will receive a random stimulation in one of the following areas: (i) the afferent portion of the vagal nerve on the Cymba Conchae of the left ear (taVNS); (ii) rPMS on an efferent portion of the vagal nerve on the neck; (iii) rTMS intermittent theta- burst on the left DLPFC; (iv) simulated taVNS (SHAM) on helix left ear or. |
|
| Chronic Pain and post Covid Syndrom - Active | Experimental | These volunteers will receive 30 minutes of taVNS on the afferent portion of the vagal nerve on the ears. |
|
| Chronic Pain and post Covid Syndrom - Sham | Sham Comparator | These volunteers will receive 30 minutes of simulated taVNS on the afferent portion of the vagal nerve on the ears. For this, the equipment will be programmed to be on only for 1 minute. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| taVNS - transauricular vagal nerve stimulation | Device | 30 minutes of electrical stimulation on the afferent portion of the vagal nerve on the cymba conchae of the ear, in the following configuration: 30 seg ramp up, 30 seg on, 30 seg off in intensity on which the volunteer feels a light tingling. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | It will be assessed through the Brief Pain Inventory (BPI), that assess place and pain intensity and its impact in life and by multidimensional pain assessment instruments to evaluate pain experience and self-efficacy | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability and blood preasure | It will be done using a chest polar and a sphygmomanometer. | 5 days |
| Pressure pain threshold. | Assessed through handgrip dynamometry. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiago S Lopes, PhD | Federal University of ABC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of ABC | Sâo Bernardo Do Campo | São Paulo | 09606045 | Brazil |
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First, we will test the savety and effects of neuromodulation using four different tecniques on autonomous system of healthy people.
Then, we will test the effect of neuromodulation through, vagal stimulation, on pain, fatigue, mental healthy and disautonomy of people with primary chronic pain and/or post-COVID syndrom. For this, active and sham stimulations will be compared.
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|
| rPMS - repetitive peripheric magnetic stimulation | Device | Magnetic stimulation on the efferent portion of the vagal nerve on the neck, on the following configuration: 20Hz, 25 pulses in the trein, in every inhalation, for 20 inhalations with 50% of machine capacity (500 pulses total). |
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| rTMS - repetitive transcranial magnetic stimulation | Device | rTMS intermitent theta- burst on the left DLPFC, on the following configuration: 50 Hz in treins of 5Hz, with 110% of the resting motor limiar and 600 pulses in 3 minutes. |
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| taVNS sham | Device | Simulated taVNS (SHAM) on helix left ear, that is the same as taVNS, but during only 1 minute |
|
| 5 days |
| TMS-Evoked potential | TMS-Evoked Potential is a measure derived from TMS stimulus on the brain which represent a brain reactivity to exogenous stimulus | 5 days |
| Disautonomy, fatigue and mental health | Dysautonomia will be assessed through TMS-EEG. Fatigue will be assessed by physical, cognitive and psychosocial fatigue scales and fatigue perception questionnaire. Mental health will be assessed by anxiety, depression and sleep quality questionnaires. Quality of life will be assessed by a specific questionnaire. | 5 days |
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D059350 | Chronic Pain |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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