Clinical trial NCT06586398: A Pilot rTMS Trial for Neuropsychiatric Symptoms of Long-COVID
Official title: A Pilot Randomized Trial of rTMS for Fatigue and Brain Fog and Neuropsychiatric Symptoms of Long-COVID.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long Covid-19
PASC Post Acute Sequelae of COVID 19
Brain Fog
Fatigue
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Tolerability as measured by Safteesi survey
timeFrame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
measure: Safety profile and adverse events
timeFrame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
Secondary outcomes:
measure: Subjective Cognitive impairment assessed by Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
timeFrame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
measure: Fatigue assessed by Fatigue Severity Scale (FSS)
timeFrame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
measure: Physical and mental health assessed by PROMIS-29
timeFrame: Baseline, through study completion, an average of 12 weeks.
measure: Alzheimer's Disease Assessment Scale (ADAS-Cog)
timeFrame: Baseline through study completion, an average of 12 weeks.
measure: Fatigue assessed by VAS for Fatigue Questionnaire
timeFrame: Baseline, after every 5th treatment, through study completion, an average of 12 weeks.
measure: DKEFS CW
timeFrame: Baseline through study completion, an average of 12 weeks.
measure: Verbal Fluency test
timeFrame: Baseline through study completion, an average of 12 weeks.
measure: DKEFS Trailmaking A,B
timeFrame: Baseline through study completion, an average of 12 weeks.
measure: Test of Premorbid Functioning (TOPF)
timeFrame: Baseline
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Baseline through study completion, an average of 12 weeks.
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Baseline through study completion, an average of 12 weeks.
measure: Repeatable Battery for the Assessment of Neuropsychological (RBANS)
timeFrame: Baseline through study completion, an average of 12 weeks.
measure: DKEFS CWI
timeFrame: Baseline through study completion, an average of 12 weeks.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Semel Institute
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Helen Lavretsky, MD
role: PRINCIPAL_INVESTIGATOR
References: