Psychiatric University Hospital Zurich
Zurich, Canton of Zurich, 8008, Switzerland
Location status: Recruiting
Recruiting
NCT Number: NCT06716996
RTMS for the Treatment of Post-COVID Associated Affective Symptoms
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can lead to major post-acute sequelae. It is estimated that over 60 million people worldwide are affected by this multisystemic condition, here referred to as post-COVID. Affective symptoms such as fatigue and depressed mood are particularly prevalent in patients with post-COVID and pose significant individual and socioeconomic burdens. This stands in stark contrast to the currently limited number of available therapeutic options. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation modality that has been demonstrated to be both safe and effective in treating various neuropsychiatric disorders, including depression. However, whether rTMS also has an effect on post-COVID associated affective symptoms remains to be elucidated.
The overall objective of this randomized, double-blinded study is twofold: First, the investigators will examine the effect of rTMS on post-COVID associated affective symptoms. 52 individuals with post-COVID will be randomized to either receive 20 sessions of rTMS or sham treatment. A detailed psychopathological assessment of the study participants will be performed before and after the completion of rTMS/sham treatment. Secondly, the investigators will perform detailed characterization of the immune system before and after rTMS/sham treatment.
The individual burden and socioeconomic costs of post-COVID-associated neuropsychiatric symptoms are enormous, however, treatment options are limited. The investigators believe that the current proposal will address this key gap in the literature by testing whether rTMS, which constitutes a novel treatment with little side effects, could alleviate these debilitating symptoms. If proven effective, this study could pave the way for a completely new way in which post-COVID conditions are treated.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion:
- Informed Consent as documented by signature
- Age between 18-65 years
- Proof of past COVID-19 infection by polymerase chain reaction (PCR) test or serology
- Negative COVID- 19 PCR test at the time of inclusion
- Affective symptoms (≥ 15 points on the Montgomery- Åsberg Depression Rating Scale) lasting for more than 12 weeks since COVID-19 infection
- No psychiatric history prior to the COVID-19 infection
- No major somatic comorbidities or substance use disorder
Exclusion:
- Contraindications to the rTMS treatment e.g. cochlear implants and metallic devices close to the TMS coil, a history of strokes, head injuries or seizures/epilepsy
- Epileptiform potentials in the electroencephalogram (EEG)
- Previous rTMS prior to the study
- Known severe hypersensitivity or severe adverse reaction to rTMS
- Women who are pregnant or breastfeeding
- Intention to become pregnant during the course of the study
- Psychiatric history prior to the COVID-19 infection
- Major somatic comorbidities e.g. renal failure, hepatic dysfunction, heart failure, cardiovascular disease.
- If the participant took antidepressants before the beginning of the study, there needs to be a washout period. The antidepressant has to be stopped for at least 3 weeks before commencing the study.
- The following drugs are not allowed during the study: any antidepressants, any antipsychotics, any drugs that lower the seizure threshold
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems
- Participation in another study with investigational treatment within the 30 days preceding and during the present study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Treatment and study plan
repeated transcranial magnetic stimulation
Device20 sessions of repeated transcranial magnetic stimulation
Other names: rTMS
Sham treatment
Device20 sessions of sham treatment
Primary outcomes
-
Depression severity
Time frame: overall up to 13 weeks depending on the amount of rTMS/sham sessions per week (including a 4 week follow up)
Depression severity will be assessed with the Montgomery-Åsberg Depression Rating Scale (MADRS)
Secondary outcomes
-
Individual symptom dimensions and levels of functioning/quality of life.
Time frame: overall up to 13 weeks depending on the amount of rTMS/sham sessions per week (including a 4 week follow up)
Secondary outcomes will be clinical variables such as individual symptom dimensions and levels of functioning/quality of life.
-
Immune markers
Time frame: overall up to 9 weeks depending on the amount of rTMS/sham sessions per week (biological variables will not be measured at the 4 week follow up)
Blood-based biological variables of the immune system
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Flurin Cathomas
Other
Collaborators
- University of Zurich
Registry information
Official study title
Repeated Transcranial Magnetic Stimulation for the Treatment of Post-COVID Associated Affective Symptoms
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Dec 4, 2024
- Registry last updated
- Dec 4, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.