RTMS for the Treatment of Post-COVID Associated Affective Symptoms

Not Applicable

Recruiting

• Conditions: Post COVID -19 Depression

• Registration Number: NCT06716996
• Lead Sponsor: Flurin Cathomas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-14
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-29
• Last Update Submitted: 2024-11-29
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2027-10-31
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression severity	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 Outcome Measures

Name	Time	Method
Individual symptom dimensions and levels of functioning/quality of life.	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	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

Trial Locations

Locations (1)

Psychiatric University Hospital Zurich; 🇨🇭 Zurich, Switzerland