Clinical trial NCT05931250: Alternating and Direct Current Stimulation for Neuropathic Eye Pain
Official title: Alternating and Direct Current Stimulation for the Treatment of Chronic Neuropathic Eye Pain and Cerebral Symptoms: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eye Pain
Neuropathy, Optic
Cerebral Injury
Lead sponsor: Region Östergötland
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2023-07-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical intervention is to test if two forms of transcranial current stimulation, transcranial direct current stimulation (tDCS) or transcranial alternating current stimulation (tACS) can alleviate neuropathic eye pain in a sample of 20 patients.

The main aims are:

* Test if tDCS/tACS can alleviate neuropathic eye pain and/or other cerebral symptoms: brain fatigue, migraine, light sensitivity, etc.
* Test if one stimulation method is superior to the other Patients will be treated for a total of fifteen 30-minute stimulation sessions, three times a day over a five-day period, each stimulation separated by approximately 4 hours, with either active tACS or tDCS over the scalp corresponding to primary sensory and motor areas.

The patients will have questionnaires to monitor subjective experiences and pupillometry before and after treatment to monitor experimental outcomes.

Detailed description: Brief Summary sufficient

Eligibility criteria: Inclusion Criteria:

* persistent eye pain for at least 6 months
* average eye pain intensity of 4 or more on a 0-10 numerical rating scale
* naive to transcranial stimulation
* eye pain having neuropathic-like characteristics

Exclusion Criteria:

* contraindication to transcranial stimulation (i.e., pacemaker, cardioverter defibrillator, neuro-stimulation (brain or spinal cord), bone growth stimulations, indwelling blood pressure monitors, epilepsy, pregnancy)
* presence of ocular diseases that are the likely cause of pain (i.e., corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, etc.)
* current participation in another study with an investigational drug or device within one month prior to screening

Primary outcomes:
measure: Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 1 week
timeFrame: through treatment completion, 1 week
measure: Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 2 weeks
timeFrame: through treatment completion, 2 weeks
measure: Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 1 month
timeFrame: through treatment completion, 1 month
measure: Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 1 week
timeFrame: through treatment completion, 1 week
measure: Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 2 weeks
timeFrame: through treatment completion, 2 weeks
measure: Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 1 month
timeFrame: through treatment completion, 1 month
measure: Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 1 week
timeFrame: through treatment completion, 1 week
measure: Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 2 weeks
timeFrame: through treatment completion, 2 weeks
measure: Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 1 month
timeFrame: through treatment completion, 1 month
measure: Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 1 week
timeFrame: through treatment completion, 1 week
measure: Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 2 weeks
timeFrame: through treatment completion, 1 month
measure: Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 1 month
timeFrame: through treatment completion, 1 month
measure: Number of patients with treatment-related adverse events as assessed by ocular pain questionnaire
timeFrame: through treatment completion, 1 month
measure: Change from baseline pupil diameter in millimeters at 1 week
timeFrame: through treament completion, 1 week
measure: Change from baseline pupil velocity in millimeters per second at 1 week
timeFrame: through treament completion, 1 week
measure: Change from baseline pupil latency in milliseconds at 1 week
timeFrame: through treament completion, 1 week
Secondary outcomes:
measure: Treatment compliance rate
timeFrame: through study completion, 1 year
Other outcomes:
measure: Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting adherence to treatment protocol
timeFrame: through study completion, 1 year
measure: Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting change in pain (Numerical Rating Scale)
timeFrame: through study completion, 1 year
Locations:
city: Linköping
country: Sweden
facility: Eye Clinic, University Hospital in Linköping
state: Other / Non-US
Study officials:
affiliation: RegionÖstergötland
name: Neil Lagali, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qazi Y, Hurwitz S, Khan S, Jurkunas UV, Dana R, Hamrah P. Validity and Reliability of a Novel Ocular Pain Assessment Survey (OPAS) in Quantifying and Monitoring Corneal and Ocular Surface Pain. Ophthalmology. 2016 Jul;123(7):1458-68. doi: 10.1016/j.ophtha.2016.03.006. Epub 2016 Apr 16.
citation: Farhangi M, Feuer W, Galor A, Bouhassira D, Levitt RC, Sarantopoulos CD, Felix ER. Modification of the Neuropathic Pain Symptom Inventory for use in eye pain (NPSI-Eye). Pain. 2019 Jul;160(7):1541-1550. doi: 10.1097/j.pain.0000000000001552.
citation: Sivanesan E, Levitt RC, Sarantopoulos CD, Patin D, Galor A. Noninvasive Electrical Stimulation for the Treatment of Chronic Ocular Pain and Photophobia. Neuromodulation. 2018 Dec;21(8):727-734. doi: 10.1111/ner.12742. Epub 2017 Dec 28.