Post COVID -19 DepressionNCT06716996
RTMS for the Treatment of Post-COVID Associated Affective Symptoms
A study testing repeated transcranial magnetic stimulation in people with Post COVID -19 Depression, run by Flurin Cathomas at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post COVID -19 Depression
- What is being tested?
- repeated transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Nov 2024to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Psychiatric University Hospital Zurich
Zurich, Canton of Zurich, 8008
Flurin Cathomas, PD Dr. med., +41583843435, flurin.cathomas@pukzh.ch
About this study
Official title: Repeated Transcranial Magnetic Stimulation 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.
- Conditions
- Post COVID -19 Depression
- Being tested
- repeated transcranial magnetic stimulation, sham treatment
- Keywords
- Post COVID -19 depression, repeated transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeated transcranial magnetic stimulationDevice
Also called rTMS
20 sessions of repeated transcranial magnetic stimulation
sham treatmentDevice
20 sessions of sham treatment
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Experimental | Not described Receives: Device: repeated transcranial magnetic stimulation |
| sham treatment | Placebo comparator | Not described Receives: Device: sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity
Depression severity will be assessed with the Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured: overall up to 13 weeks depending on the amount of rTMS/sham sessions per week (including a 4 week follow up)
Secondary outcomes (2)
Individual symptom dimensions and levels of functioning/quality of life.
Secondary outcomes will be clinical variables such as individual symptom dimensions and levels of functioning/quality of life.
Measured: overall up to 13 weeks depending on the amount of rTMS/sham sessions per week (including a 4 week follow up)
Immune markers
Blood-based biological variables of the immune system
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start14 Nov 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID -19 DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flurin Cathomas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Flurin Cathomas, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716996
- Sponsor's protocol ID
- TMS-CO
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Transcranial Magnetic Stimulation for the Treatment of Post-COVID Associated Affective Symptoms
- ClinicalTrials.gov ID
- NCT06716996
- Acronym / sponsor ID
- TMS-CO
- Conditions
- Post COVID -19 Depression
- Keywords
- Post COVID -19 depression, repeated transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Flurin CathomasUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS | Experimental | Device: repeated transcranial magnetic stimulation |
| sham treatment | Placebo comparator | Device: sham treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repeated transcranial magnetic stimulationAlso: rTMS20 sessions of repeated transcranial magnetic stimulation | Device | rTMS |
| sham treatment20 sessions of sham treatment | Device | sham treatment |
Primary outcome
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)
2 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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repeated transcranial magnetic stimulation in people with Post COVID -19 Depression, run by Flurin Cathomas at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flurin Cathomas, PD Dr. med. (+41583843435, flurin.cathomas@pukzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.