A Pilot rTMS Trial for Neuropsychiatric Symptoms of Long-COVID

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Sep 3, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called repetitive Transcranial Magnetic Stimulation (rTMS) for people experiencing ongoing symptoms after recovering from COVID-19, commonly referred to as Long COVID. Specifically, the trial is focusing on symptoms like fatigue, brain fog, and other mental health challenges. Twenty participants from the UCLA Long-COVID clinic will be randomly assigned to receive either the active rTMS treatment or a sham (placebo) treatment. Each participant will undergo a total of 30 treatment sessions, and the researchers will monitor how safe and tolerable the treatment is while also measuring changes in symptoms related to fatigue, sleep, pain, mood, and cognitive function.

To be eligible for this study, participants must be 18 years or older, have a confirmed prior COVID-19 infection, and have developed neuropsychiatric symptoms like fatigue and brain fog. They should also be stable on any prescribed mental health medications for at least four months. The trial is seeking individuals who are willing and able to commit to the treatment schedule, but certain conditions, such as severe mental health disorders or specific medical conditions, may exclude potential participants. This trial is important as it aims to gather initial data that could lead to larger studies in the future, potentially improving treatment options for those suffering from Long COVID.

Gender

ALL

Eligibility criteria

• 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.