Microcurrent Device (TIVIC Health)

NCT05198518 | Completed Results FDA Device

• 1 other identifier: STUDY-21-01392
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Rhinosinusitis

Keywords

chronic rhinosinusitis; postoperative pain; microcurrent

Outcome Measures

Primary Outcomes (7)

• Change in Pain Visual Analog Score After First Use of Device

  Change in postoperative pain score in first use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the first time they use the device.

  baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure

• Change in Pain Visual Analog Score After Second Use of Device

  Change in postoperative pain score after second use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the second time they use the device.

  baseline, 10 min, 2 hour, 4 hour at second use within 14 days after procedure

• Change in Pain Visual Analog Score After Third Use of Device

  Change in postoperative pain score after third use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the third time they use the device.

  baseline, 10 min, 2 hour, 4 hour at 3rd use within 14 days after procedure

• Change in Pain Visual Analog Score After Fourth Use of Device

  Change in postoperative pain score after fourth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fourth time they use the device.

  baseline, 10 min, 2 hour, 4 hour at fourth use within 14 days after procedure

• Change in Pain Visual Analog Score After Fifth Use of Device

  Change in postoperative pain score after fifth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fifth time they use the device.

  baseline, 10 min, 2 hour, 4 hour at fifth use within 14 days after procedure

• Sino-Nasal Outcome Test (SNOT 22)

  The possible range of Total SNOT scores is between 0 to 110. Higher scores indicate greater rhinosinusitis-related health burden.

  Baseline and 2 weeks Post-Op

• Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score

  Full scale from 0-100. Higher score indicates more severe symptoms

  Baseline and 2 weeks Post-Op

Secondary Outcomes (6)

• Debridement Associated Pain Visual Analog Score Before Use of Device

  baseline, 10 min, 2 hour, 4 hour on POD14

• Debridement Associated Pain Visual Analog Score After First Use of Device

  baseline, 10 min, 2 hour, 4 hour on POD14

• Debridement Associated Pain Visual Analog Score After Second Use of Device

  baseline, 10 min, 2 hour, 4 hour on POD14

• Debridement Associated Pain Visual Analog Score After Third Use of Device

  baseline, 10 min, 2 hour, 4 hour on POD14

• Debridement Associated Pain Visual Analog Score After Fourth Use of Device

  baseline, 10 min, 2 hour, 4 hour on POD14

Study Arms (2)

Microcurrent TENS device

EXPERIMENTAL

A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region

Device: Microcurrent TENS device

Sham device

SHAM COMPARATOR

The sham device appears identical to the active device while emitting no therapeutic microcurrent.

Device: Sham Device

Interventions

Microcurrent TENS device DEVICE

The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.

Also known as: Microcurrent neuromodulation device

Microcurrent TENS device

Sham Device DEVICE

The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.

Sham device

Eligibility Criteria

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

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
• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Tivic Health Systems: collaborator

Study Sites (1)

Faculty Practice Associates - Mount Sinai Doctors

New York, New York, 10028, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Alfred Marc C Iloreta Jr, MD
• Organization: Icahn School of Medicine at Mount Sinai

alfred-marc.iloreta@mountsinai.org

(212) 241-9410

Study Officials

• Alfred-Marc Iloreta, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant and all study staff will be blinded to which device they are receiving, either the study device or the identical sham device. Devices will be labeled A or B, with only the device manufacturer knowing which device is the active study device and which is the sham.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Subjects will be randomly assigned in a 1:1 ratio to receive the intervention or placebo. Randomization will be completed via a computer-generated randomization table.

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 20, 2022
• Study Start: March 30, 2022
• Primary Completion: March 19, 2024
• Study Completion: April 4, 2024
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)