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TMS treatment study for long COVID

A Multicenter Randomized Sham-Controlled Comarative Trial to Develop a Non-invasive Neuromodulation Treatment with Novel Transcranial Magnetic Stimulation for Anxiety-Depression and Cognitive Dysfunction Associated with Post-COVID-19 Syndrome - TMS-RCT for Post-COVID-19 Syndrome

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032230291
Enrollment
55
Registered
2023-08-14
Start date
2023-08-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-COVID-19 syndrome (anxiety depression and cognitive dysfunction) Post-COVID-19 syndrome, Long COVID, depression, anxiety and insomnia, cognitive decline and brain fog, chronic fatigue

Interventions

Sponsors

Ohsawa Ryota
Lead Sponsor
Noda Yoshihiro
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Individuals who were infected with COVID-19 and tested positive by PCR test, etc., and subsequently became negative 2) Individuals who met the diagnostic criteria for depression or anxiety disorder in the DSM-5 for the first time after COVID-19 infection 3) Individuals with severity of 15 or more points on the MADRS 4) Individuals who are deemed capable of giving written consent by the physician in charge 5) Individuals between the ages of 18 and 70 at the time of obtaining consent 6) Individuals who can regularly visit the institution during the period of TMS therapy

Exclusion criteria

Exclusion criteria: 1) Individuals with cerebral organic diseases (e.g., intracranial organic lesions of moderate severity or higher, neurodegenerative diseases, etc.) 2) Individuals with primary sleep disorders (sleep apnea, narcolepsy, etc.) 3) Individuals with a diagnosis of bipolar disorder, schizophrenia, psychotic depression, or substance abuse/dependence 4) Individuals diagnosed with autoimmune or endocrine-metabolic diseases (hypopituitarism, adrenal insufficiency, thyroid disease, diabetes mellitus, etc.) 5) Individuals with a history of convulsive seizures or epilepsy 6) Individuals with serious or unstable physical illnesses that make it difficult for them to receive outpatient TMS therapy 7) Individuals who have received ECT within the past 6 months 8) Individuals who are pregnant 9) Individuals with contraindications to TMS, such as metallic objects in the head and neck region or cardiac pacemakers 10) Individuals deemed inappropriate by the principal investigator or co-investigators

Design outcomes

Primary

MeasureTime frame
Changes in HAMD-21 score before and after the novel TMS treatment

Secondary

MeasureTime frame
Changes in the following items before and after the novel TMS therapeutic intervention - MADRS - BSI-anxiety - BSS - PSQI - GAF - Q-LES-Q - TMT - LNST - SNST - EXIT25

Contacts

Public ContactYoshihiro Noda

Shinjuku-Yoyogi Mental Lab Clinic

yoshi-tms@keio.jp+81-3-5357-7385

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026