Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07278206

Mitigating Cognitive Problems and Fatigue With Brain Stimulation in Long COVID

Led by Amsterdam UMC, location VUmc · Updated on 2025-12-19

66

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

A

Amsterdam UMC, location VUmc

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research focuses on adults experiencing long COVID, also called Post-COVID Condition or Post-Acute Sequelae of COVID-19 (PASC), who suffer from severe fatigue and trouble concentrating. The study aims to evaluate whether repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, can reduce fatigue and improve cognitive function. Previous research suggests that brain blood flow and inflammation changes may underlie these symptoms, and rTMS has shown promise in related conditions. Participants will be randomly assigned to receive either active rTMS or a sham (placebo) version over a period of six weeks, with four sessions each week, totaling 24 sessions. Active rTMS involves delivering magnetic pulses to a specific brain area identified by MRI scans during a planning task, while sham treatment mimics the procedure without effective stimulation. Treatment targets the left dorsolateral prefrontal cortex, and the environment is adjusted to reduce sensory stress for participants. Participants will undergo assessments before treatment, shortly after, and during follow-ups at three and six months. These include fatigue measurements, cognitive tests, brain imaging (MRI), blood biomarker analysis, physical performance tests, and surveys on mood, sleep, and quality of life. Activity levels are tracked with a watch, and safety monitoring occurs throughout. The study lasts several months to observe effects and gather detailed information on brain and body changes related to treatment.

CONDITIONS

Brief Title

Brain Stimulation in Long COVID

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet the World Health Organization (WHO) definition of long COVID
  • Aged 18 years or older
  • Severe fatigue, defined as a score of 35 or higher on the Checklist Individual Strength (CIS) fatigue subscale
  • Significant cognitive complaints, defined as a score of 18 or higher 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
Not Eligible

You will not qualify if you...

  • Prior rTMS treatment or current intensive/experimental treatment for long COVID
  • History of epilepsy or first-degree family history of epilepsy
  • Recent start or dosage change of psychotropic medication less than six weeks ago (including antidepressants and antipsychotics) or less than two weeks for benzodiazepines
  • Other active pharmacological treatments for post-COVID symptoms
  • Contraindications to MRI (e.g., non-removable metal implants, severe claustrophobia)
  • Presence of cochlear implant
  • Neurological disorders such as multiple sclerosis or neurodegenerative diseases
  • Pregnancy
  • Known brain lesions or ischemic scars affecting seizure threshold
  • Severe uncontrolled migraines
  • Severe cardiovascular disease
  • Raised intracranial pressure
  • High alcohol consumption (males: over 21 units/week; females: over 14 units/week) or use of epileptogenic drugs
  • Severe sleep deprivation at time of treatment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 6 weeks

Participants receive brain stimulation treatment using repetitive transcranial magnetic stimulation (rTMS) or sham stimulation. Treatment is delivered four times per week for six consecutive weeks, totaling up to 24 sessions with a minimum effective dose of 16 sessions to accommodate participant burden.

4 visits per week for 6 weeks

Follow-up

Duration - 4 months

Participants return for outcome assessments to evaluate fatigue, cognitive function, and other health measures at 3 and 6 months after treatment to assess long-term effects.

2 visits (at 3 and 6 months post-treatment)

Trial Site Locations

Total: 1 location

1

Amsterdam UMC

Amsterdam, Netherlands

Actively Recruiting

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Research Team

C

Céline N Dietz, MSc, MA

S

Sander C.J. Verfaillie, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Is the efficacy of repetitive transcranial magnetic stimulation influenced by baseline severity of fatigue symptom in patients with myalgic encephalomyelitis.

De Gang Yang, Rui Gu, Jin Kubo...

https://pubmed.ncbi.nlm.nih.gov/31483181

Neuropsychological functioning after COVID-19: Minor differences between individuals with and without persistent complaints after SARS-CoV-2 infection.

Anouk Verveen, Sander C J Verfaillie, Denise Visser...

https://pubmed.ncbi.nlm.nih.gov/39016843

Neurobiological basis and risk factors of persistent fatigue and concentration problems after COVID-19: study protocol for a prospective case-control study (VeCosCO).

Anouk Verveen, Sander C J Verfaillie, Denise Visser...

https://pubmed.ncbi.nlm.nih.gov/37399444

Impairment of executive performance after transcranial magnetic modulation of the left dorsal frontal-striatal circuit.

Odile A van den Heuvel, Helene C Van Gorsel, Dick J Veltman...

https://pubmed.ncbi.nlm.nih.gov/22076808

Greater fatigue is more strongly associated with reduced reward sensitivity in the long-term phase of coronavirus disease (COVID-19) than in the early phase.

Judith M Scholing, Britt I H M Lambregts, Ruben van den Bosch...

https://pubmed.ncbi.nlm.nih.gov/40686929

Effect of Repetitive Transcranial Magnetic Stimulation on Long Coronavirus Disease 2019 with Fatigue and Cognitive Dysfunction.

Nobuyuki Sasaki, Masato Yamatoku, Tomoya Tsuchida...

https://pubmed.ncbi.nlm.nih.gov/36861061