Clinical trial NCT03674892: Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain
Official title: Assessing the Efficacy of Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cornea
Keywords: Intranasal Neurostimulation
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 24
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: non-randomized, open-label, single arm pilot trial
Primary purpose: TREATMENT

Brief summary: This study is a prospective, interventional, open-label, single arm, non-randomized trial treating 30 patients with peripheral or mixed neuropathic corneal pain at their baseline exam and following 45 days and 90 days of daily use with the TrueTear™ ITN device.

Detailed description: The investigators hypothesize that the stimulation through the ethmoidal nerve in the nasal cavity may have an inhibitory effect on the primary TG interneurons and block the ocular pain signaling to the brain.

The investigators propose a non-randomized, open-label, single arm pilot trial for treatment of neuropathic corneal pain (NCP) with ITN with the following specific aims:

Specific Aims:

1. To elucidate the efficacy of ITN in ameliorating pain among neuropathic corneal pain patients.
2. To elucidate the safety, efficacy, longevity of ITN in ameliorating pain among neuropathic corneal pain patients during a 90-day period with daily use.
3. To assess quality of life changes by treating neuropathic corneal pain with ITN during a 90-day period with daily use.

Eligibility criteria: Inclusion Criteria:

1. Age \>22
2. Ability to consent to study.
3. Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort or pain.
4. Positive in vivo confocal microscopy (IVCM) findings for NCP such as presence of microneuromas and decreased nerve density.
5. Fifty percent or more relief of pain or discomfort after instillation of Proparacaine eye drops as measured by the Visual Analogue Scale (VAS).

Exclusion Criteria:

1. Clinically significant acute ocular surface diseases, such as active infectious keratitis or recent ocular surgery in the past 3 months.
2. Chronic or recurrent epistaxis, coagulation disorders.
3. Nasal or sinus surgery or significant trauma to the nose.
4. Severe nasal airway obstruction or vascularized nasal polyps.
5. Cardiac demand pacemaker, implanted defibrillator, or other implanted electronic device in the head or neck.
6. Chronic or recurrent nosebleeds
7. Bleeding disorder
8. Known hypersensitivity (allergy) to the hydrogel material
9. Disabling arthritis, neuropathy, or limited motor coordination affecting self-handling of the device.

Primary outcomes:
measure: Change in pain score measured by the Visual Analogue Scale (VAS) after intranasal neurostimulator (ITN) stimulation
timeFrame: 90 days
Secondary outcomes:
measure: Corneal nerve density measured by laser in vivo confocal microscopy (IVCM) in mm/mm2
timeFrame: 90 days
measure: Response to proparacaine drops based on Visual Analogue Scale (VAS) scores
timeFrame: 90 days
measure: Quality of Life (QoL) based on the multidimensional ocular pain questionnaire
timeFrame: 90 days
measure: Change in quality of life as measured daily with Impact of Dry Eye on Everyday Life (IDEEL)
timeFrame: 90 days
measure: Micro-neuroma density measured by laser in vivo confocal microscopy (IVCM) in unit/ mm2
timeFrame: 90 days
measure: Change in the intraocular pressure (IOP) measured in mmHg
timeFrame: 90 days
measure: Tolerability of ITN
timeFrame: 90 days
measure: Changes in the current systemic medications
timeFrame: 90 days
measure: Response to hyperosmolar drops based on Visual Analogue Scale (VAS) scores
timeFrame: 90 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Pedram Hamrah, MD
role: PRINCIPAL_INVESTIGATOR
References: