Brain Stimulation in Long COVID

NCT07278206 | Recruiting

• 2 other identifiers: NL-00920711080022420018
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID; PASC Post Acute Sequelae of COVID 19; Post COVID-19 Condition (PCC)

Keywords

TMS; PASC; long COVID; PCC; neuroimaging; non-invasive brain stimulation; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Fatigue as measured by the 8-item fatigue subscale of the Checklist Individual Strength (CIS). The subscale is scored on a 7-point Likert scale, adding up to a total score between 8 and 56. A score of 35 or higher indicates the presence of severe fatigue.

  Fatigue will be measured within two weeks before and within two weeks after treatment, and at 3 and 6 months follow-up.

Secondary Outcomes (30)

• Objective cognitive functioning

  Objective cognitive functioning will be measured two weeks before and two weeks after treatment and at 3 and 6 months follow-up after treatment.

• Arterial Spin Labeling (ASL)

  Neuroimaging will be performed within two weeks before and within two weeks after treatment.

• Magnetic Resonance Spectroscopy (MRS)

  Neuroimaging will be performed within two weeks before and within two weeks after treatment.

• Functional Magnetic Resonance Imaging (fMRI)

  Neuroimaging will be performed within two weeks before and within two weeks after treatment.

• Actigraphy

  Continuous period of eight days two weeks before and directly after treatment

Other Outcomes (1)

• Heart rate variability (HRV)

  Four nights and four mornings two weeks before and directly after treatment

Study Arms (2)

Active rTMS

EXPERIMENTAL

The active intervention will consist of high-frequency rTMS delivered to the left dorsolateral prefrontal cortex (DLPFC). Stimulation will be administered at 10 Hz frequency, 110% of the individual's resting motor threshold and then adjusted for the individual cortex-skull distance, with 3,000 pulses per session with a total duration of 30 minutes (60 trains of 5 seconds, 25-second inter-train intervals).

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

SHAM COMPARATOR

Sham-stimulation will be administered at 60% motor threshold at the same location (left DLPFC) using a placebo coil, which is identical to the stimulation coil in appearance, but with a built-in metal plate that blocks most of the active stimulation while maintaining mechanical scalp sensation.

Device: Sham device

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

The active intervention will consist of high-frequency (10 Hz) TMS delivered to the left dorsolateral prefrontal cortex (DLPFC), at 110% of the individual's resting motor threshold, adjusted for the individual cortex-skull distance, with 3,000 pulses per session with a total duration of 30 minutes (60 trains of 5 seconds, 25-second inter-train intervals). Sham-stimulation will be administered at 60% motor threshold at the same location (left DLPFC) using a placebo coil, which is identical to the stimulation coil in appearance, but with a built-in metal plate that blocks most of the active stimulation while maintaining mechanical scalp sensation. The stimulation target will be individualized using functional MRI data acquired during a Tower of London planning task allowing neuronavigation to the site of task-related activation. Each participant will receive four sessions per week for six weeks, totaling 24 sessions.

Also known as: rTMS, TMS, non-invasive brain stimulation, NIBS

Active rTMS

Sham device DEVICE

Sham-stimulation will be administered at 60% motor threshold at the left DLPFC using a placebo coil, which is identical to the stimulation coil in appearance, but with a built-in metal plate that blocks most of the active stimulation while maintaining mechanical scalp sensation. 3,000 pulses per session will be applied with a total duration of 30 minutes (60 trains of 5 seconds, 25-second inter-train intervals). The stimulation target will be individualized using functional MRI data acquired during a Tower of London planning task, allowing neuronavigation to the site of task-related activation. Each participant will receive four sessions per week for six weeks, totaling 24 sessions.

Also known as: Sham rTMS, Sham TMS, Placebo, Placebo coil

Sham rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Post Covid Netwerk Nederland: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Related Publications (30)

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Related Links

• Study website

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Sander C.J. Verfaillie, Dr.

  Amsterdam UMC, GGZ InGeest

  PRINCIPAL INVESTIGATOR

• Odile A van den Heuvel, Prof. Dr.

  Amsterdam UMC

  STUDY CHAIR

• Ysbrand D van der Werf, Prof. Dr.

  Amsterdam UMC

  STUDY CHAIR

• Esmée Verwijk, Dr.

  University of Amsterdam, Amsterdam UMC

  STUDY CHAIR

• Céline N Dietz, MSc/MA

  Amsterdam UMC

  STUDY DIRECTOR

Central Study Contacts

Céline N Dietz, MSc, MA

CONTACT

+31634010994; c.n.dietz@amsterdamumc.nl

Sander C.J. Verfaillie, Dr.

CONTACT

+31634005199; s.verfaillie@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and the investigators conducting neuropsychological assessment and doing data analysis will remain blinded to treatment allocation. Due to the nature of the intervention, rTMS technicians cannot be blinded. However, they will be asked not to reveal allocation to participants and other researchers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 11, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): November 17, 2028
• Study Completion (Estimated): May 12, 2029
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)