Microcurrent Device (TIVIC Health)
Completed · Not applicable · Has a placebo group
Conditions studied: Chronic Rhinosinusitis
In brief
The purpose of this study is to investigate whether daily use of a microcurrent neuromodulation device, which applies a small current of electricity to the forehead and maxillary region, will decrease the pain experienced by patients in the days following functional endoscopic sinus surgery (FESS). This study is a prospective randomized controlled study. Enrolled subjects will be randomized (1:1) to receive either an active neuromodulation study device or a sham device that appears identical to the active device while emitting no therapeutic microcurrent. Subjects will self-treat with the device at home and will be followed for 2 weeks after FESS.
Key facts
- Study ID
- NCT05198518
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 60
- Starts
- 2022-03-30
- Expected to finish
- 2024-04-04
- Last updated by the study team
- 2025-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Scheduled for FESS functional nasal or endoscopic sinus surgery
- Possessing an American Society of Anesthesiologists physical status classification of I or II
- Age ≥ 18
- Possess the capacity to give informed consent
- Able to read, write and understand English or Spanish
- Able to attend follow up visits at postop days 7 and 14 Visit 1 (within 0 - day 14) and post-op Visit 2 (within 10 - 21 days)
- Postop pain VAS ≥ 5 in PACU phase II
You may not qualify if…
- Age < 18
- Does not understand English or Spanish
- Does not meet inclusion criteria
- History of chronic pain
- Experiencing chronic pain requiring opioids at baseline and/or who are under the care of pain management specialists
- Neurologic disorders (including seizure disorders)
- Undergoing planned or unplanned additional procedures at the time of FESS surgery
- In custody of the state
- Prisoners
- Known to be pregnant
- Implanted cranial metallic components or devices including deep brain stimulators or cochlear implants
- Has an implanted or external worn cardiac device including pacemakers, automated implantable cardioverter defibrillator (AICD), or any other cardiac electric devices (including non-implanted devices, e.g. defibrillator vest)
Where it is running
- Faculty Practice Associates - Mount Sinai Doctors — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.