Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.

NCT05780450 | Unknown

• 1 other identifier: UCV/2021-2022/140
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to verify the efficacy / effectiveness of treatment with transcranial direct therapy (TDCS) in patients with Persistent Covid who present headaches, migraines and chronic pain, such as arthralgias and myalgias. Transcranial Direct Therapy is used in the field of Physiotherapy and Rehabilitation, with results that prove to be effective for the treatment of patients suffering from symptoms such as migraines, headaches, chronic pain, fibromyalgia or chronic neuropathic pain. As can be seen, in the case of patients with Persistent Covid we find several of these symptoms, so it is suggested that, if Transcranial Direct Current Therapy (TDCs) is giving such good results, relieving these symptoms, why can not give such good results and help so much in patients with Persistent Covid, If many of the symptoms are the same, even if the origin or cause is different.

Conditions

COVID-19; Long COVID; Long Covid19; SARS CoV 2 Infection; Persistent COVID-19; Migraine Disorders; Headaches Chronic; Cluster Headache; Arthralgia; Myalgia; Chronic Pain; Post-COVID-19 Syndrome; Post COVID-19 Condition

Keywords

Transcranial Direct Current Stimulation; tDCS; Covid Persistente

Outcome Measures

Primary Outcomes (2)

• CHANGE FROM PRE-TREATMENT DEGREE CHRONIC BODY PAIN AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS

  MEASURED WITH 2 SPECIFIC PAIN SCALES (EVA-Visual Analog SCALE AND MCGILL PAIN QUESTIONNAIRE). EVA SCALE (0 no pain-10 maximun pain). MCGILL QUESTIONNAIRE (0 no pain-66 maximun pain)

  PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS

• CHANGE FROM PRE-TREATMENT INTENSE MIGRAINES OR HEADACHES AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS

  MEASURED WITH 2 SPECIFIC SCALES (MIDAS-Migraine dissability Assessment SCALE AND HIT-6 QUESTIONNAIRE-headache impact test). MIDAS SCALE (0 nil disability - \>21 severe disability). HIT-6 QUESTIONNAIRE (0 no impact - \>60 very severe impact).

  PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS

Secondary Outcomes (2)

• CHANGE FROM PRE-TREATMENT QUALITY OF LIFE (SF-12 QUESTIONNAIRE) AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS

  PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS

• CHANGE FROM PRE-TREATMENT MOOD AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS

  PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS

Study Arms (1)

Treatment group

EXPERIMENTAL

Device: Transcranial Direct Current Therapy (tDCS)

Interventions

Transcranial Direct Current Therapy (tDCS) DEVICE

Transcranial direct therapy (tDCS) is a non-invasive neuromodulation therapy of the cerebral cortex, which consists of the application of electrical microcurrents, of approximately 2mA, through surface electrodes placed on the scalp. Transcranial therapy (tDCS) produces immediate effects on the ability of neurons to change their electrical potential. Each session lasts between 20 and 30 minutes, and approximately 10 consecutive sessions should be performed. It will be applied through two surface electrodes of 25 to 35 cm2 at 2 mA. The equipment has a European health certificate (CE), so it is an approved equipment that complies with all the safety measures for the application of the treatment.

Treatment group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Persistent Covid
• Men and women
• All ages from 16 years old
• Patients who passed the Covid in its acute phase in an asymptomatic, mild and severe way.

You may not qualify if:

• Patients without confirmation with positive PCR in the acute phase of Covid-19
• Patients with Persistent Covid who do not have at least one of these symptoms: migraines, headaches, chronic pain, neuropathic pain, arthralgia, myalgias
• Patients with pacemaker / defibrillator
• Patients with brain implants
• Patients with cranial fractures
• Pregnant

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (2)

Clínica Paiporta

Paiporta, Valencia, 46200, Spain

RECRUITING

Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of Valencia San Vicente Mártir)

Valencia, 46001, Spain

RECRUITING

Related Publications (2)

• Conde-Anton A, Hernando-Garijo I, Jimenez-Del-Barrio S, Mingo-Gomez MT, Medrano-de-la-Fuente R, Ceballos-Laita L. Effects of transcranial direct current stimulation and transcranial magnetic stimulation in patients with fibromyalgia. A systematic review. Neurologia (Engl Ed). 2020 Oct 15:S0213-4853(20)30278-4. doi: 10.1016/j.nrl.2020.07.024. Online ahead of print. English, Spanish.

  PMID: 33071017 BACKGROUND

• Pacheco-Barrios K, Cardenas-Rojas A, Thibaut A, Costa B, Ferreira I, Caumo W, Fregni F. Methods and strategies of tDCS for the treatment of pain: current status and future directions. Expert Rev Med Devices. 2020 Sep;17(9):879-898. doi: 10.1080/17434440.2020.1816168. Epub 2020 Sep 15.

  PMID: 32845195 BACKGROUND

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Migraine Disorders; Headache Disorders; Cluster Headache; Arthralgia; Myalgia; Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trigeminal Autonomic Cephalalgias; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• LAURA GARCÍA MARTÍNEZ

  Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of Valencia San Vicente Mártir)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LAURA GARCÍA MARTÍNEZ

CONTACT

+34691635330; lauragarciamartinez@mail.ucv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 22, 2023
• Study Start: April 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)