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

June 12, 2023 updated by: Fundación Universidad Católica de Valencia San Vicente Mártir

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Valencia, Spain, 46001
        • Recruiting
        • Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of Valencia San Vicente Mártir)
        • Principal Investigator:
          • LAURA GARCÍA MARTÍNEZ
        • Contact:
    • Valencia
      • Paiporta, Valencia, Spain, 46200
        • Recruiting
        • Clínica Paiporta
        • Contact:
        • Contact:
        • Principal Investigator:
          • LAURA GARCÍA MARTÍNEZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHANGE FROM PRE-TREATMENT DEGREE CHRONIC BODY PAIN AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS
Time Frame: PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 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
Time Frame: PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHANGE FROM PRE-TREATMENT QUALITY OF LIFE (SF-12 QUESTIONNAIRE) AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS
Time Frame: PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 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
CHANGE FROM PRE-TREATMENT MOOD AT INMEDIATE POST-TREATMENT, 1 MONTH AND 3 MONTHS
Time Frame: PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Investigators

  • Principal Investigator: LAURA GARCÍA MARTÍNEZ, Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of Valencia San Vicente Mártir)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

July 1, 2023

Study Completion (Estimated)

July 1, 2023

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCV/2021-2022/140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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