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

COVID-19 Clinical Trial

Official title:

Effectiveness of Transcranial Direct Current (tDCS) Treatment in Patients With Persistent Covid Who Present Headaches and Chronic Body Pain.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780450
• Other study ID #: UCV/2021-2022/140
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: July 2023

Study information

• Verified date: March 2023
• Source: Fundación Universidad Católica de Valencia San Vicente Mártir
• Contact: LAURA GARCÍA MARTÍNEZ
• Phone: +34691635330
• Email: lauragarciamartinez[@]mail.ucv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arthralgia
• Chronic Pain
• Cluster Headache
• COVID-19
• Headache
• Headaches Chronic
• Long COVID
• Migraine Disorders
• Myalgia
• Post-COVID-19 Syndrome

Intervention

Device:
• Transcranial Direct Current Therapy (tDCS)
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.

Locations

Country	Name	City	State
Spain	Clínica Paiporta	Paiporta	Valencia
Spain	Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of Valencia San Vicente Mártir)	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Universidad Católica de Valencia San Vicente Mártir

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	CHANGE FROM PRE-TREATMENT QUALITY OF LIFE (SF-12 QUESTIONNAIRE) AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS	MEASURED WITH 1 SPECIFIC SCALE (SF-12 QUESTIONNAIRE). (0 worst quality of life - 100 best quality of life)	PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS
Secondary	CHANGE FROM PRE-TREATMENT MOOD AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS	MEASURED WITH 1 SPECIFIC SCALE (EVEA-mood rating SCALE). (0 nothing - 10 a lot)	PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS