| NCT ID | NCT07278206 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amsterdam UMC, location VUmc |
| Condition | Long COVID |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2025-11-17 |
| Primary Completion | 2028-11-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2025-11-17 with a primary completion date of 2028-11-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cognitive problems and severe fatigue are two frequently occurring symptoms in long COVID, also known as Post-Covid Condition or Post-Acute Sequelae of COVID-19 (PASC), and their causes are currently unknown. Previous studies have shown reduced blood flow and increased inflammation in the brains of people with PASC. These brain processes are related to fatigue and cognitive problems. In other conditions, these disrupted brain processes have been treated safely and successfully with non-invasive brain stimulation. This may offer an effective treatment for people with PASC. The main goal of this clinical trial is to see whether non-invasive brain stimulation called repetitive transcranial magnetic stimulation (rTMS) can reduce fatigue in adults with PASC who also have trouble concentrating. rTMS uses short magnetic pulses on the scalp to gently stimulate a small brain area. In this study, 66 adults with PASC will be included, recruited through the Post-COVID Network Netherlands. Participants will be randomly assigned to receive either active rTMS or sham (placebo) rTMS. Sham rTMS feels and looks similar to the active treatment, but it does not generate effective magnetic pulses. The brain area that will be targeted is personalized using a brain scan (MRI) during a planning task. All participants will receive 24 rTMS sessions over six weeks (four per week). Fatigue will be measured within two weeks before and two weeks after treatment to determine whether active rTMS works better than sham. We will also look at cognition, brain connectivity and blood flow, signs of (neuro)inflammation, daily activity using an activity watch, and questionnaires about quality of life, mood, and sleep. Follow-up on cognition and questionnaires will take place 3 and 6 months after the end of the treatment.
Eligibility Criteria
Inclusion Criteria: * Meet the World Health Organization (WHO) definition of long COVID. * Aged 18 years or older. * Severe fatigue, defined as a score ≥35 on the Checklist Individual Strength (CIS) fatigue subscale. * Significant cognitive complaints, defined as a score ≥18 on the CIS concentration subscale. * Commitment to actively undergo rTMS * Ability to attend the study site regularly for treatment sessions. * Capacity to provide written informed consent. Exclusion Criteria: * Prior rTMS treatment or current intensive/experimental treatment for long COVID. * History of epilepsy or first-degree family history of epilepsy. * Recent initiation or dosage change of psychotropic medication (less than six weeks for psychotropic medication including antidepressants and antipsychotic drugs, less than two weeks for benzodiazepines). Medication doses must remain stable during the study. * Other active concurrent pharmacological treatments for post-covid symptoms * Contraindications to MRI scanning (e.g., non-removable metallic implants, severe claustrophobia). * Presence of a cochlear implant. * Neurological disorders such as multiple sclerosis or other neurodegenerative conditions. * Pregnancy. * Known brain lesions or ischaemic scars influencing seizure threshold. * Severe uncontrolled migraines. * Severe cardiovascular disease * Raised intracranial pressure. * High alcohol consumption (males/females: 21/14 units per week) or use of epileptogenic drugs. * Severe sleep deprivation at the time of treatment.
Contact & Investigator
Sander C.J. Verfaillie, Dr.
PRINCIPAL INVESTIGATOR
Amsterdam UMC, GGZ InGeest
Frequently Asked Questions
Who can join the NCT07278206 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Long COVID. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07278206 currently recruiting?
Yes, NCT07278206 is actively recruiting participants. Contact the research team at c.n.dietz@amsterdamumc.nl for enrollment information.
Where is the NCT07278206 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT07278206 clinical trial?
NCT07278206 is sponsored by Amsterdam UMC, location VUmc. The principal investigator is Sander C.J. Verfaillie, Dr. at Amsterdam UMC, GGZ InGeest. The trial plans to enroll 66 participants.
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