Long Covid-19NCT06586398
A Pilot rTMS Trial for Neuropsychiatric Symptoms of Long-COVID
A study testing rTMS in people with Long Covid-19 and PASC Post Acute Sequelae of COVID 19, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This is a pilot randomized trial of rTMS for symptoms of fatigue and brain fog, and other neuropsychiatric symptoms of Long-COVID (Post-COVID, post-acute sequelae of COVID-19 infection, PASC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Covid-19, PASC Post Acute Sequelae of COVID 19, Brain Fog
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years of age
- Prior hx of PCR confirmed COVID-19 infection. Determined by the PI or participant's physician.
- Subsequent development of post-acute neuropsychiatric symptoms with fatigue and brain fog as primary outcomes
- USE of Psychotropic medications
- Stable on psychotropic medications for 4+ months
- Confirmed diagnosis of Long COVID
- Subjects are willing and able to adhere to the treatment schedule and required study visits
Who cannot join
- Mentally or legally incapacitated or unable to give informed consent
- MOCA < or = 24
- Infection of poor skin condition over the scalp where the rTMS device will be positioned
- Pregnancy: Female participants will be tested for pregnancy at baseline and agree to use a medically acceptable form of birth control throughout the study, for women younger than 60.
- Lifetime history of diagnosed bipolar disorder; psychosis, such as schizophrenia, schizophreniform, or schizoaffective disorder; intellectual disability (intellectual developmental disorder); organic brain damage; or suicide attempts in the past 24 months.
- Severe MDD with suicidality of Psychosis- excluded
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- As-needed use of benzodiazepines and beta-blockers will be permitted but discouraged during assessment days.
- Current abuse or dependence on alcohol or any illicit drug of abuse (disorder in last 6 months). Any recent use of cocaine or opiates will also be exclusionary.
- Participants with asthma or with a history of serious, uncontrolled medical illness or instability (including significant cardio-pulmonary disease, organic brain including significant cardio-pulmonary syndrome, pre-existing dementia, seizure disorder, cerebrovascular disease, and diabetes)
- Taking medications known to lower seizure thresholds (Clozaril/ Wellbutrin)
- Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or primary or secondary tumors in the central nervous system.
- Presence of an implanted metallic and magnetic-sensitive medical device present in the body scan, including but not limited to a cochlear implant, infusion pump, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, aneurysm clip, metal prosthesis, or metal aneurysm clips or coils, staples, or stents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Trial of rTMS for Fatigue and Brain Fog and Neuropsychiatric Symptoms of Long-COVID.
This is a pilot randomized trial of rTMS for symptoms of fatigue and brain fog, and other neuropsychiatric symptoms of Long-COVID (Post-COVID, post-acute sequelae of COVID-19 infection, PASC). Twenty participants diagnosed with Long-COVID and recruited from the UCLA Long-COVID clinic will be randomized to receive active rTMS versus sham stimulation for 15 treatments followed by another 15 open-label rTMS treatments. Investigators will compare the safety and tolerability of rTMS vs Sham and examine within-group changes in symptoms of fatigue, sleep, pain, mood, and subjective and objective cognitive impairment. This project will provide information and pilot data for future larger clinical trials.
- Being tested
- rTMS
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Mental Fatigue, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Also called repetitive transcranial magnetic stimulation
Participants will be randomized to 15 sessions of double-blind multi-target rTMS treatment (active vs sham) and then will receive only open-label active stimulation for another 15 sessions. Each session will include rTMS to the left dorsolateral prefrontal cortex (DLPFC), followed by rTMS to left primary motor cortex (M1).
| Study group | Role | What they receive |
|---|---|---|
| active rTMS | Active comparator | The rTMS magnet will be set to active stimulation without the knowledge of treating doctors or research team. Only one technician will know the randomization list assignment and will adjust the settings. rTMS treatment will include rTMS to the left dorsolateral prefrontal cortex (DLPFC), followed by rTMS to left primary motor cortex (M1). Receives: Device: rTMS |
| Sham rTMS | Sham comparator | The rTMS magnet will be set to sham stimulation without the knowledge of the treating doctors or the research team. Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability as measured by Safteesi survey
Safteesi is an instrument that assesses any new symptom(s) that participants developed since starting the clinical study.
Measured: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
Safety profile and adverse events
Study patients will be monitored weekly for the occurrence of adverse events.
Measured: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
Secondary outcomes (13)
Subjective Cognitive impairment assessed by Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
MISC is a brief 10-item survey that measures perceived cognitive function. The MISCI is normally distributed and has low rates of ceiling and floor effects, excellent internal consistency, and good construct validity in correlation with other measures.
Measured: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
Fatigue assessed by Fatigue Severity Scale (FSS)
The FSS is a nine-item, self-report instrument designed to assess fatigue as a symptom of different chronic conditions and disorders. The scale addresses fatigue's effect on daily functioning and its relationship to motivation, physical activity, work, family, and social life. Participants will rate the ease with which they are fatigued and the degree to which the symptoms pose a problem.
Scoring uses a scale that ranges from 1 (completely disagree) to 7 (completely agree) to indicate agreement with the nine statements about fatigue.
Measured: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
Physical and mental health assessed by PROMIS-29
The PROMIS-29 measures pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain.
Measured: Baseline, through study completion, an average of 12 weeks.
Alzheimer's Disease Assessment Scale (ADAS-Cog)
Cognitive performance will be assessed by ADAS-Cog
Measured: Baseline through study completion, an average of 12 weeks.
Fatigue assessed by VAS for Fatigue Questionnaire
VAS is a one-question self-report survey that asks "How much fatigue are you having now?" on a scale of 0 (no fatigue) to 10 (worst possible fatigue).
Measured: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
DKEFS CW
Verbally mediated processing speed and executive functioning will be assessed using the DKEFS Color Word Test.
Measured: Baseline through study completion, an average of 12 weeks.
Verbal Fluency test
The Verbal Fluency test will be used to assess global cognitive abilities.
Measured: Baseline through study completion, an average of 12 weeks.
DKEFS Trailmaking A,B
Speed for attention, sequencing, mental flexibility, visual search, and motor functioning will be assessed by the DKEFS Trailmaking tests.
Measured: Baseline through study completion, an average of 12 weeks.
Test of Premorbid Functioning (TOPF)
TOPF will be used to estimate pre-morbid cognitive and memory functioning.
Measured: Baseline
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
RBANS story memory subtest is used to assess immediate memory.
Measured: Baseline through study completion, an average of 12 weeks.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
RBANS story recall subtest will be used to assess delayed memory
Measured: Baseline through study completion, an average of 12 weeks.
Repeatable Battery for the Assessment of Neuropsychological (RBANS)
Processing speed, short-term visual memory, psychomotor speed, cognitive flexibility, concentration, and motivation will be assessed by RBANS Coding subtest.
Measured: Baseline through study completion, an average of 12 weeks.
DKEFS CWI
Selective attention, cognitive flexibility, and processing speed will be assessed by the DKEFS Color Word Interference test.
Measured: Baseline through study completion, an average of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Covid-19Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Lavretsky, MD, University of California, Los Angeles
- Investigators
- Helen Lavretsky, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586398
- Sponsor's protocol ID
- 24-000555
- Status last verified
- Jul 2026
- First submitted
- 21 Aug 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial of rTMS for Fatigue and Brain Fog and Neuropsychiatric Symptoms of Long-COVID.
- ClinicalTrials.gov ID
- NCT06586398
- Acronym / sponsor ID
- 24-000555
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 19 Sep 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.
This is a pilot randomized trial of rTMS for symptoms of fatigue and brain fog, and other neuropsychiatric symptoms of Long-COVID (Post-COVID, post-acute sequelae of COVID-19 infection, PASC). Twenty participants diagnosed with Long-COVID and recruited from the UCLA Long-COVID clinic will be randomized to receive active rTMS versus sham stimulation for 15 treatments followed by another 15 open-label rTMS treatments. Investigators will compare the safety and tolerability of rTMS vs Sham and examine within-group changes in symptoms of fatigue, sleep, pain, mood, and subjective and objective cognitive impairment. This project will provide information and pilot data for future larger clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active rTMS | Active comparator | Device: rTMSThe rTMS magnet will be set to active stimulation without the knowledge of treating doctors or research team. Only one technician will know the randomization list assignment and will adjust the settings. rTMS treatment will include rTMS to the left dorsolateral prefrontal cortex (DLPFC), followed by rTMS to left primary motor cortex (M1). |
| Sham rTMS | Sham comparator | Device: rTMSThe rTMS magnet will be set to sham stimulation without the knowledge of the treating doctors or the research team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18+ years of age
- Prior hx of PCR confirmed COVID-19 infection. Determined by the PI or participant's physician.
- Subsequent development of post-acute neuropsychiatric symptoms with fatigue and brain fog as primary outcomes
- USE of Psychotropic medications
- Stable on psychotropic medications for 4+ months
Key exclusion criteria (12 listed)
- Mentally or legally incapacitated or unable to give informed consent
- MOCA < or = 24
- Infection of poor skin condition over the scalp where the rTMS device will be positioned
- Pregnancy: Female participants will be tested for pregnancy at baseline and agree to use a medically acceptable form of birth control throughout the study, for women younger than 60.
- Lifetime history of diagnosed bipolar disorder; psychosis, such as schizophrenia, schizophreniform, or schizoaffective disorder; intellectual disability (intellectual developmental disorder); organic brain damage; or suicide attempts in the past 24 months.
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 |
|---|---|---|
| rTMSAlso: repetitive transcranial magnetic stimulationParticipants will be randomized to 15 sessions of double-blind multi-target rTMS treatment (active vs sham) and then will receive only open-label active stimulation for another 15 sessions. Each session will include rTMS to the left dorsolateral prefrontal cortex (DLPFC), followed by rTMS to left primary motor cortex (M1). | Device | Sham rTMS, active rTMS |
Primary outcome
Tolerability as measured by Safteesi survey
Time frame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
Safteesi is an instrument that assesses any new symptom(s) that participants developed since starting the clinical study.
Safety profile and adverse events
Time frame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
Study patients will be monitored weekly for the occurrence of adverse events.
13 secondary outcomes
Subjective Cognitive impairment assessed by Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
Time frame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
Fatigue assessed by Fatigue Severity Scale (FSS)
Time frame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
Physical and mental health assessed by PROMIS-29
Time frame: Baseline, through study completion, an average of 12 weeks.
Alzheimer's Disease Assessment Scale (ADAS-Cog)
Time frame: Baseline through study completion, an average of 12 weeks.
Fatigue assessed by VAS for Fatigue Questionnaire
Time frame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
DKEFS CW
Time frame: Baseline through study completion, an average of 12 weeks.
Verbal Fluency test
Time frame: Baseline through study completion, an average of 12 weeks.
DKEFS Trailmaking A,B
Time frame: Baseline through study completion, an average of 12 weeks.
Test of Premorbid Functioning (TOPF)
Time frame: Baseline
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: Baseline through study completion, an average of 12 weeks.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: Baseline through study completion, an average of 12 weeks.
Repeatable Battery for the Assessment of Neuropsychological (RBANS)
Time frame: Baseline through study completion, an average of 12 weeks.
DKEFS CWI
Time frame: Baseline through study completion, an average of 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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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. This study is not recruiting at the moment.
Helen Lavretsky, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Long Covid-19 and PASC Post Acute Sequelae of COVID 19, run by University of California, Los Angeles at 1 site in United States.
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 12 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: finished, as of the sponsor's last update on 6 Jul 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability as measured by Safteesi survey (time frame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.). The study lists 2 primary outcomes in all. 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 6 Jul 2026.