Actively Recruiting
RTMS for the Treatment of Post-COVID Associated Affective Symptoms
Led by Flurin Cathomas · Updated on 2024-12-04
52
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
F
Flurin Cathomas
Lead Sponsor
U
University of Zurich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RTMS for the Treatment of Post-COVID Associated Affective Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age between 18 and 65 years
- Past COVID-19 infection confirmed by PCR test or serology
- Negative COVID-19 PCR test at inclusion
- Affective symptoms scoring 15 or more on the Montgomery-Åsberg Depression Rating Scale lasting over 12 weeks since COVID-19 infection
- No psychiatric history before COVID-19 infection
- No major medical conditions or substance use disorder
You will not qualify if you...
- Contraindications to rTMS such as cochlear implants, metal near the TMS coil, history of strokes, head injuries, seizures, or epilepsy
- Epileptiform potentials on EEG
- Previous rTMS treatment before this study
- Known severe allergy or bad reaction to rTMS
- Women who are pregnant, breastfeeding, or plan to become pregnant during the study
- Psychiatric history before COVID-19 infection
- Major medical conditions like kidney failure, liver dysfunction, heart failure, or cardiovascular disease
- Use of antidepressants before study without a 3-week washout period
- Use of antidepressants, antipsychotics, or drugs lowering seizure threshold during the study
- Known or suspected drug or alcohol abuse
- Inability to follow study procedures, including language barriers
- Participation in another investigational study within 30 days before or during this study
- Investigators, their family, employees, or dependents cannot participate
AI-Screening
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Trial Site Locations
Total: 1 location
1
Psychiatric University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8008
Actively Recruiting
Research Team
F
Flurin Cathomas, PD Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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