Alternating and Direct Current Stimulation for Neuropathic Eye Pain

Cerebral Injury Clinical Trial

Official title:

Alternating and Direct Current Stimulation for the Treatment of Chronic Neuropathic Eye Pain and Cerebral Symptoms: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05931250
• Other study ID #: 20220727401
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Region Östergötland
• Contact: Neil Lagali, PhD
• Phone: +4613286680
• Email: neil.lagali[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Brief Summary sufficient

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Injury
• Eye Pain
• Neuropathy, Optic
• Optic Nerve Diseases

Intervention

Device:
• DC-Stimulator Plus (NeuroConn GmbH, Germany)
Transcranial alternating current stimulation
• Sooma direct current stimulator (Sooma, Finland)
Transcranial direct current stimulation

Locations

Country	Name	City	State
Sweden	Eye Clinic, University Hospital in Linköping	Linköping	Other / Non-US

Sponsors (2)

Lead Sponsor	Collaborator
Neil Lagali	Linkoeping University

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting adherence to treatment protocol	Exploratory regression analysis to identify associations between demographic variables and number of treatment sessions completed	through study completion, 1 year
Other	Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting change in pain (Numerical Rating Scale)	Exploratory regression analysis to identify associations between demographic variables and change in pain ratings (before vs. after stimulation treatment)	through study completion, 1 year
Primary	Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 1 week	Assesses pain related symptoms on a scale from 0 indicating no pain (better outcome) to10 indicating worst pain imaginable (worse outcome)	through treatment completion, 1 week
Primary	Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 2 weeks	Assesses pain related symptoms on a scale from 0 indicating no pain (better outcome) to10 indicating worst pain imaginable (worse outcome)	through treatment completion, 2 weeks
Primary	Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 1 month	Assesses pain related symptoms on a scale from 0 indicating no pain (better outcome) to10 indicating worst pain imaginable (worse outcome)	through treatment completion, 1 month
Primary	Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 1 week	Assesses pain related symptoms effecting sleep, stress, disposition, life quality, on a scale from 0 indicating no effect (better outcome) to10 indicating maximum effect (worse outcome)	through treatment completion, 1 week
Primary	Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 2 weeks	Assesses pain related symptoms effecting sleep, stress, disposition, life quality, on a scale from 0 indicating no effect (better outcome) to10 indicating maximum effect (worse outcome)	through treatment completion, 2 weeks
Primary	Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 1 month	Assesses pain related symptoms effecting sleep, stress, disposition, life quality, on a scale from 0 indicating no effect (better outcome) to10 indicating maximum effect (worse outcome)	through treatment completion, 1 month
Primary	Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 1 week	Assesses mental symptoms on a scale from 0 indicating no effect (better outcome) to 3 indicating extreme effect (worse outcome)	through treatment completion, 1 week
Primary	Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 2 weeks	Assesses mental symptoms on a scale from 0 indicating no effect (better outcome) to 3 indicating extreme effect (worse outcome)	through treatment completion, 2 weeks
Primary	Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 1 month	Assesses mental symptoms on a scale from 0 indicating no effect (better outcome) to 3 indicating extreme effect (worse outcome)	through treatment completion, 1 month
Primary	Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 1 week	Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)	through treatment completion, 1 week
Primary	Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 2 weeks	Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)	through treatment completion, 1 month
Primary	Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 1 month	Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)	through treatment completion, 1 month
Primary	Number of patients with treatment-related adverse events as assessed by ocular pain questionnaire	Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)	through treatment completion, 1 month
Primary	Change from baseline pupil diameter in millimeters at 1 week	Minimum and maximum pupil diameter in millimeters	through treament completion, 1 week
Primary	Change from baseline pupil velocity in millimeters per second at 1 week	Pupil change velocity in millimeters per second	through treament completion, 1 week
Primary	Change from baseline pupil latency in milliseconds at 1 week	Pupil latency latency in milliseconds	through treament completion, 1 week
Secondary	Treatment compliance rate	Evaluation of completed treatment from a total of 15	through study completion, 1 year