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accelerated intermittent theta burst stimulation · 1 trial · 5 indications
Demonstrate that accelerated iTBS is effective and feasible for reducing neuro-PASC symptoms. Change in the score in the "Cognitive Function/Brain Fog Symptoms" score from the PACS: Post-acute COVID-19 Syndrome Questionnaire, where low scores are more severe symptoms compared to higher scores. Scale 1-Severly Unable to 4-Able. Higher scores show improvement in symptoms.
Identify neurometabolic and structural features associated with outcomes in MANIFEST. ADCcho in the thalamus measured using dMRS. The apparent diffusion coefficient of choline (ADCcho) is a measure of activity of microglia, higher values indicate higher levels of microglia. Decreased ADCcho means less microglia activation, and less inflammation.
| Arm | Type | Description |
|---|---|---|
| Sham accelerated iTBS | SHAM_COMPARATOR | Sham stimulation is delivered using the same coil as active stimulation, producing an equivalent sound, however it is shielded so that no effective magnetic field reaches the participant's brain. To blind participants to active versus sham condition, a mild electrical skin stimulation that has no brain effects is delivered simultaneously with iTBS at the scalp to both active and sham groups, creating the same sense of skin sensation in both groups. |
| Active accelerated iTBS | EXPERIMENTAL | Participants will be assigned to receive fMRI-guided iTBS (5 days, 5 sessions/day) to the left dorsolateral prefrontal cortex (dlPFC) during the sham-controlled phase. Each participant is invited to undergo 25 more sessions (5 more days) of open label, unblinded active accelerated fMRI-guided iTBS to the left dlPFC. |
| Name | Type | Description |
|---|---|---|
| accelerated intermittent theta burst stimulation | DEVICE | Intermittent theta burst stimulation (iTBS), a FDA-approved form of noninvasive neuromodulation, can reduce neuropsychiatric symptoms and modulate inflammation in the thalamus as detected using dMRS, suggesting a potentially effective and efficient treatment approach with a pathophysiological component that is readily quantifiable. |
Inclusion Criteria: 1. aged 18-80 2. a documented diagnosis of PASC with evidence of ongoing symptoms as demonstrated by score of 12 on the NIH RECOVER Symptom List 3. have "brain fog" or cognitive difficulties as one of the ongoing symptoms 4. are fluent in English 5. if taking psychotropic medica...
Accelerated intermittent theta burst stimulation is an investigational therapy being studied for Long COVID, also known as Long COVID Syndrome, Long COVID-19 Syndrome, PASC, and Post Acute Sequelae of COVID 19. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Accelerated intermittent theta burst stimulation is being developed by United Therapeutics Corporation, a company traded on the NASDAQ under the ticker symbol UTHR. The therapy is currently in Phase 2 clinical trials for the treatment of Long COVID.
Accelerated intermittent theta burst stimulation is in Phase 2 clinical development. It is an investigational therapy for Long COVID and is not yet approved by the FDA. The therapy is being evaluated in a randomized, double-blind, sham-controlled clinical trial.
Accelerated intermittent theta burst stimulation is being studied in a Phase 2 clinical trial with the identifier NCT06940609, titled Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation. The trial is currently recruiting 60 participants in the United States and is randomized, double-blind, and sham-controlled.
Accelerated intermittent theta burst stimulation is a distinct investigational therapy being studied specifically for Long COVID. It is not known to be the same as any other named treatment for this condition. The therapy is currently in Phase 2 clinical trials and has not been approved by regulatory authorities.