Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can lead to major post-acutesequelae. It is estimated that over 60 million people worldwide are affected by thismultisystemic condition, here referred to as post-COVID. Affective symptoms such asfatigue and depressed mood are particularly prevalent in patients with post-COVID andpose significant individual and socioeconomic burdens. This stands in stark contrast tothe currently limited number of available therapeutic options. Repetitive transcranialmagnetic stimulation (rTMS) is a non-invasive brain stimulation modality that has beendemonstrated to be both safe and effective in treating various neuropsychiatricdisorders, including depression. However, whether rTMS also has an effect on post-COVIDassociated affective symptoms remains to be elucidated.The overall objective of this randomized, double-blinded study is twofold: First, theinvestigators will examine the effect of rTMS on post-COVID associated affectivesymptoms. 52 individuals with post-COVID will be randomized to either receive 20 sessionsof rTMS or sham treatment. A detailed psychopathological assessment of the studyparticipants will be performed before and after the completion of rTMS/sham treatment.Secondly, the investigators will perform detailed characterization of the immune systembefore and after rTMS/sham treatment.The individual burden and socioeconomic costs of post-COVID-associated neuropsychiatricsymptoms are enormous, however, treatment options are limited. The investigators believethat the current proposal will address this key gap in the literature by testing whetherrTMS, which constitutes a novel treatment with little side effects, could alleviate thesedebilitating symptoms. If proven effective, this study could pave the way for acompletely new way in which post-COVID conditions are treated.
Not Provided
Device: repeated transcranial magnetic stimulation
20 sessions of repeated transcranial magnetic stimulation
Other Name: rTMS
Device: sham treatment
20 sessions of sham treatment
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
Psychiatric University Hospital Zurich
Zurich, Switzerland
Investigator: Flurin Cathomas, PD Dr. med.
Contact: +41583843435
flurin.cathomas@pukzh.ch
Flurin Cathomas, PD Dr. med.
+41583843435
flurin.cathomas@pukzh.ch
Not Provided