This is a pilot randomized trial of rTMS for symptoms of fatigue and brain fog, and otherneuropsychiatric symptoms of Long-COVID (Post-COVID, post-acute sequelae of COVID-19infection, PASC). Twenty participants diagnosed with Long-COVID and recruited from theUCLA Long-COVID clinic will be randomized to receive active rTMS versus sham stimulationfor 15 treatments followed by another 15 open-label rTMS treatments. Investigators willcompare the safety and tolerability of rTMS vs Sham and examine within-group changes insymptoms of fatigue, sleep, pain, mood, and subjective and objective cognitiveimpairment. This project will provide information and pilot data for future largerclinical trials.
Not Provided
Device: rTMS
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).
Other Name: repetitive transcranial magnetic stimulation
Inclusion Criteria:
1. 18+ years of age
2. Prior hx of PCR confirmed COVID-19 infection. Determined by the PI or participant's
physician.
3. Subsequent development of post-acute neuropsychiatric symptoms with fatigue and
brain fog as primary outcomes
4. USE of Psychotropic medications
5. Stable on psychotropic medications for 4+ months
6. Confirmed diagnosis of Long COVID
7. Subjects are willing and able to adhere to the treatment schedule and required study
visits
Exclusion Criteria:
1. Mentally or legally incapacitated or unable to give informed consent
2. MOCA < or = 24
3. Infection of poor skin condition over the scalp where the rTMS device will be
positioned
4. 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.
5. 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.
6. Severe MDD with suicidality of Psychosis- excluded
7. As-needed use of benzodiazepines and beta-blockers will be permitted but discouraged
during assessment days.
8. 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.
9. 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)
10. Taking medications known to lower seizure thresholds (Clozaril/ Wellbutrin)
11. 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.
12. 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.
UCLA Semel Institute
Los Angeles, California, United States
Investigator: Helen Lavretsky, MS, MD
Helen Lavretsky, MD
(310) 794-4619
hlavretsky@mednet.ucla.edu
Courtney Sheen, MA
(310) 794-9523
csheen@mednet.ucla.edu
Helen Lavretsky, MD, Principal Investigator
University of California, Los Angeles