Mitigating Cognitive Problems and Fatigue With Brain Stimulation in Long COVID

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Contact Information
Primary
Céline N Dietz, MSc, MA
c.n.dietz@amsterdamumc.nl
+31634010994
Backup
Sander C.J. Verfaillie, Dr.
s.verfaillie@amsterdamumc.nl
+31634005199
Time Frame
Start Date: 2025-11-17
Estimated Completion Date: 2029-05-12
Participants
Target number of participants: 66
Treatments
Experimental: Active rTMS
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).
Sham_comparator: Sham rTMS
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.
Related Therapeutic Areas
Sponsors
Collaborators: Post Covid Netwerk Nederland, ZonMw: The Netherlands Organisation for Health Research and Development
Leads: Amsterdam UMC, location VUmc

This content was sourced from clinicaltrials.gov