UCLA Semel Institute
Los Angeles, California, 90095, United States
NCT Number: NCT06586398
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Los Angeles, California, 90095, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: repetitive transcranial magnetic stimulation
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.
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.
Time frame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
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.
Time frame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
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.
Time frame: Baseline, through study completion, an average of 12 weeks.
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.
Time frame: Baseline through study completion, an average of 12 weeks.
Cognitive performance will be assessed by ADAS-Cog
Time frame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
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).
Time frame: Baseline through study completion, an average of 12 weeks.
Verbally mediated processing speed and executive functioning will be assessed using the DKEFS Color Word Test.
Time frame: Baseline through study completion, an average of 12 weeks.
The Verbal Fluency test will be used to assess global cognitive abilities.
Time frame: Baseline through study completion, an average of 12 weeks.
Speed for attention, sequencing, mental flexibility, visual search, and motor functioning will be assessed by the DKEFS Trailmaking tests.
Time frame: Baseline
TOPF will be used to estimate pre-morbid cognitive and memory functioning.
Time frame: Baseline through study completion, an average of 12 weeks.
RBANS story memory subtest is used to assess immediate memory.
Time frame: Baseline through study completion, an average of 12 weeks.
RBANS story recall subtest will be used to assess delayed memory
Time frame: Baseline through study completion, an average of 12 weeks.
Processing speed, short-term visual memory, psychomotor speed, cognitive flexibility, concentration, and motivation will be assessed by RBANS Coding subtest.
Time frame: Baseline through study completion, an average of 12 weeks.
Selective attention, cognitive flexibility, and processing speed will be assessed by the DKEFS Color Word Interference test.
University of California, Los Angeles
Other
A Pilot Randomized Trial of rTMS for Fatigue and Brain Fog and Neuropsychiatric Symptoms of Long-COVID.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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