A Pilot rTMS Trial for Neuropsychiatric Symptoms of Long-COVID

University of California, Los Angeles (UCLA)

Status: Active, not recruiting

Conditions: Long Covid-19; PASC Post Acute Sequelae of COVID 19; Fatigue; Brain Fog

Treatments: Device: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06586398

24-000555

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups

active rTMS

Active Comparator group

Description:

The rTMS magnet will be set to active stimulation without the knowledge of treating doctors or research team. Only one technician will know the randomization list assignment and will adjust the settings. rTMS treatment will include rTMS to the left dorsolateral prefrontal cortex (DLPFC), followed by rTMS to left primary motor cortex (M1).

Treatment:

Device: rTMS

Sham rTMS

Sham Comparator group

Description:

The rTMS magnet will be set to sham stimulation without the knowledge of the treating doctors or the research team.

Treatment:

Device: rTMS