Brain Stimulation in Long COVID

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation
  • Sham device

Treatment groups

66 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Amsterdam UMC, location VUmc

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator

Post Covid Netwerk Nederland

Collaborator