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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Eye Clinic, University Hospital in Linköping | Linköping | Other / Non-US |
Lead Sponsor | Collaborator |
---|---|
Neil Lagali | Linkoeping University |
Sweden,
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
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 |
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