COVID-19NCT05780450
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
A study testing Transcranial Direct Current Therapy (tDCS) in people with COVID-19 and Long COVID, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 2 sites in Spain.
Trial summary
This study aims to verify the efficacy/effectiveness of treatment with transcranial direct current stimulation (TDCS) in patients with Long Covid who experience headaches, migraines, and chronic pain, such as arthralgia and myalgia, as well as sleep problems. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COVID-19, Long COVID, Long Covid19
- What is being tested?
- Transcranial Direct Current Therapy (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Apr 2023to 1 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Clínica Paiporta
Paiporta, Valencia, 46200
BENJAMÍN CUENCA VALERO, +34636695885, info@clinicapaiporta.com
LAURA GARCÍA MARTÍNEZ, +34691635330, info@clinicapaiporta.com
- Recruiting
Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of Valencia San Vicente Mártir)
Valencia, Valencia, 46001
JORGE ALARCÓN JIMÉNEZ, jorge.alarcon@ucv.es
LAURA GARCÍA MARTÍNEZ
About this study
Official title: 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 current stimulation (TDCS) in patients with Long Covid who experience headaches, migraines, and chronic pain, such as arthralgia and myalgia, as well as sleep problems. Transcranial direct current stimulation is used in the field of Physiotherapy and Rehabilitation, with results that have proven to be effective for treating patients suffering from symptoms like migraines, headaches, chronic pain, fibromyalgia, or chronic neuropathic pain and insomnia. As you can see, in the case of patients with Long Covid, we find several of these symptoms, so it is suggested that if transcranial direct current therapy (TDCS) gives such good results in relieving these symptoms, why couldn't it give such good results and help just as much in patients with Long Covid, since many of the symptoms are the same, even if the origin or cause is different.
Read the detailed description
Study extension (amendment to protocol UCV/2021-2022/140, approved by the Research Ethics Committee of the Catholic University of Valencia, ref. UCV/2022-2023/072, on October 28, 2024). After the initial phase, in which participants with Long COVID received anodal tDCS, the study was extended to a randomized, sham-controlled, double-blind phase. Participants are randomized 1:1:1:1 to anodal (original arm, recruitment continued), bifrontal, cathodal or sham tDCS. Objectives, eligibility criteria and primary outcome are unchanged. Planned enrollment: initial phase, 27 participants; randomized extension phase, 60 participants (15 per arm). Between-group comparisons will include only participants randomized in the extension phase; initial-phase data will be reported separately and used only in supplementary analyses within the anodal tDCS arm. Sleep outcomes (PSQI, ISI, ESS) were added as secondary outcomes in the extension phase only.
The initial phase was approved by the Research Ethics Committee of the Catholic University of Valencia (ref. UCV/2021/2022/140); the extension was approved by the Research Ethics Committee of the Catholic University of Valencia (ref. UCV/2022-2023/072) on October 28, 2024.
- Conditions
- COVID-19, Long COVID, Long Covid19, SARS CoV 2 Infection, Persistent COVID-19, Migraine Disorders
- Being tested
- Transcranial Direct Current Therapy (tDCS), Sham (No Treatment)
- Keywords
- Transcranial Direct Current Stimulation, tDCS, Covid Persistente
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome, Migraine Disorders, Headache Disorders, Cluster Headache, Arthralgia, Myalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 20 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.
Sham (No Treatment)Device
Same electrode montage as other arm; current ramped up and then down, then switched off, to mimic the sensations of active stimulation. Same session schedule as active arms.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Placebo comparator | Same electrode montage as another arm; current ramped up and down, then switched off, to mimic the sensations of active stimulation. Receives: Device: Sham (No Treatment) |
| Anodal tDCS | Experimental | Original arm. Anode over M1/C3, cathode over Fp2 Receives: Device: Transcranial Direct Current Therapy (tDCS) |
| Cathodal tDCS | Experimental | Cathode over M1/C3, anode over Fp2; same intensity, duration and number of sessions. Receives: Device: Transcranial Direct Current Therapy (tDCS) |
| Bifrontal tDCS | Experimental | Anode over F3, cathode over F4; same intensity, duration and number of sessions. Receives: Device: Transcranial Direct Current Therapy (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHANGE FROM PRE-TREATMENT DEGREE CHRONIC BODY PAIN AT INMEDIATE POST-TREATMENT, 1 MONTH, 3 MONTHS AND 6 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)
Measured: PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS / 6 MONTHS
CHANGE FROM PRE-TREATMENT INTENSE MIGRAINES OR HEADACHES AT INMEDIATE POST-TREATMENT, 1 MONTH, 3 MONTHS AND 6 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).
Measured: PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS / 6 MONTHS
Secondary outcomes (4)
CHANGE FROM PRE-TREATMENT QUALITY OF LIFE (SF-12 QUESTIONNAIRE) AT INMEDIATE POST-TREATMENT, 1 MONTH, 3 MONTHS AND 6 MONTHS
MEASURED WITH 1 SPECIFIC SCALE (SF-12 QUESTIONNAIRE). (0 worst quality of life - 100 best quality of life)
Measured: PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS / 6 MONTHS
CHANGE FROM PRE-TREATMENT MOOD AT INMEDIATE POST-TREATMENT, 1 MONTH, 3 MONTHS AND 6 MONTHS
MEASURED WITH 1 SPECIFIC SCALE (EVEA-mood rating SCALE). (0 nothing - 10 a lot)
Measured: PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS / 6 MONTHS
CHANGE FROM PRE-TREATMENT SLEEP QUALITY (SF-12 QUESTIONNAIRE) AT INMEDIATE POST-TREATMENT, 1 MONTH, 3 MONTHS AND 6 MONTHS
MEASURED WITH 3 SPECIFIC SCALES (ISI-Insomnia Severity Index, Pittsburg Sleep Quality Index AND Epworth Sleepiness Scale). ISI (0-7 no insomnia, 8-14 subclinical insomnia, 15-21 moderated insomnia, 22-28 severe insomnia). PITTSBURG (0-4 good sleep quality, > 5 sleep problems). EPWORTH (0-10 normal sleepiness, 11-14 mild daytime sleepiness, 15-18 moderate daytime sleepiness, 19-24 severe daytime sleepiness).
Measured: PRE-TREATMENT / IMMEDIATE POST-TREATMENT / POST-TREATMENT 1 MONTH / 3 MONTHS / 6 MONTHS
BRAIN RESILIENCE (EEG-TMS) AT PRE-TREATMENT AND INMEDIATE POST-TREATMENT
EEG-TMS AND PPTMS PRE-TREATMENT AND INMEDIATE POST-TREATMENT
Measured: PRE-TREATMENT / IMMEDIATE POST-TREATMENT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Apr 2023
- Primary completion5 Nov 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Initial single-arm phase (anodal tDCS) followed by a four-arm randomized parallel extension phase.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente Mártir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Alarcón Jiménez, Fundación Universidad Católica de Valencia San Vicente Mártir
- Investigators
- LAURA GARCÍA MARTÍNEZ, Principal investigator, Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of Valencia San Vicente Mártir)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780450
- Sponsor's protocol ID
- UCV/2021-2022/140
- Other IDs
- UCV/2021-2022/140
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33071017Pacheco-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.
PubMed 32845195