A Pilot rTMS Trial for Neuropsychiatric Symptoms of Long-COVID (NCT06586398) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
A Pilot rTMS Trial for Neuropsychiatric Symptoms of Long-COVID
United States10 participantsStarted 2025-01-01
Plain-language 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). 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. 18+ years of age
ā. Prior hx of PCR confirmed COVID-19 infection. Determined by the PI or participant's physician.
ā. Subsequent development of post-acute neuropsychiatric symptoms with fatigue and brain fog as primary outcomes
ā. USE of Psychotropic medications
ā. Stable on psychotropic medications for 4+ months
ā. Confirmed diagnosis of Long COVID
ā. Subjects are willing and able to adhere to the treatment schedule and required study visits
Exclusion criteria
ā. Mentally or legally incapacitated or unable to give informed consent
ā. MOCA \< or = 24
ā. Infection of poor skin condition over the scalp where the rTMS device will be positioned
What they're measuring
1
Tolerability as measured by Safteesi survey
Timeframe: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
2
Safety profile and adverse events
Timeframe: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
. 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.
ā. 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.
ā. Severe MDD with suicidality of Psychosis- excluded
ā. As-needed use of benzodiazepines and beta-blockers will be permitted but discouraged during assessment days.
ā. 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.