A Pilot rTMS Trial for Neuropsychiatric Symptoms of Long-COVID

N/AActive Not RecruitingNCT06586398

University of California, Los Angeles10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Tolerability as measured by Safteesi survey

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.

Safety profile and adverse events

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.

Secondary Outcomes

Subjective Cognitive impairment assessed by Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)

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.

Fatigue assessed by Fatigue Severity Scale (FSS)

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, after every 5th treatment, through study completion, an average of 12 weeks.

Physical and mental health assessed by PROMIS-29

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.

Alzheimer's Disease Assessment Scale (ADAS-Cog)

Cognitive performance will be assessed by ADAS-Cog