rTMS for Fatigue and Brain Fog in Long-COVID
rTMS
COVID-19+20
+ Post-Acute COVID-19 Syndrome
+ Post-Infectious Disorders
Treatment Study
Summary
Study start date: January 1, 2025
Actual date on which the first participant was enrolled.This clinical trial is exploring a treatment called rTMS, which stands for repetitive Transcranial Magnetic Stimulation, to help people suffering from Long-COVID. Long-COVID can cause lingering symptoms like extreme tiredness, brain fog, and other mental health issues even after recovering from the initial COVID-19 infection. The study aims to see if rTMS can relieve these symptoms, making life easier for those affected. It targets individuals diagnosed with Long-COVID and hopes to provide useful information for future, larger studies. Participants in this study will be split into two groups. One group will receive the active rTMS treatment, while the other will receive a sham, or placebo-like, stimulation. Each group will undergo 15 treatment sessions, followed by 15 more sessions where all participants receive the active treatment. Researchers will monitor the safety and how well participants tolerate the rTMS compared to the sham treatment. They will also assess changes in symptoms such as fatigue, sleep issues, pain, mood, and cognitive impairment, both from the participants' perspectives and through objective measures.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ShamGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location