A Pilot rTMS Trial for Neuropsychiatric Symptoms of Long-COVID

NCT06586398 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 24-000555
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Tolerability as measured by Safteesi survey

  Safteesi is an instrument that assesses any new symptom(s) that participants developed since starting the clinical study.

  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.

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

Secondary Outcomes (13)

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

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

• Fatigue assessed by Fatigue Severity Scale (FSS)

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

• Physical and mental health assessed by PROMIS-29

  Baseline, through study completion, an average of 12 weeks.

• Alzheimer's Disease Assessment Scale (ADAS-Cog)

  Baseline through study completion, an average of 12 weeks.

• Fatigue assessed by VAS for Fatigue Questionnaire

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

Study Arms (2)

active rTMS

ACTIVE COMPARATOR

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).

Device: rTMS

Sham rTMS

SHAM COMPARATOR

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

Device: rTMS

Interventions

rTMS DEVICE

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).

Also known as: repetitive transcranial magnetic stimulation

Sham rTMS; active rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age
• Prior hx of PCR confirmed COVID-19 infection. Determined by the PI or participant's physician.
• Subsequent development of post-acute neuropsychiatric symptoms with fatigue and brain fog as primary outcomes
• USE of Psychotropic medications
• Stable on psychotropic medications for 4+ months
• Confirmed diagnosis of Long COVID
• Subjects are willing and able to adhere to the treatment schedule and required study visits

You may not qualify if:

• Mentally or legally incapacitated or unable to give informed consent
• MOCA \< or = 24
• Infection of poor skin condition over the scalp where the rTMS device will be positioned
• 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.
• 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.
• Severe MDD with suicidality of Psychosis- excluded
• As-needed use of benzodiazepines and beta-blockers will be permitted but discouraged during assessment days.
• 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)
• Taking medications known to lower seizure thresholds (Clozaril/ Wellbutrin)
• 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.
• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Mental Fatigue; Fatigue

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Helen Lavretsky, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants and investigators and outcomes assessors will be blind to the assignment to active or sham rTMS
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (1)