Alternating and Direct Current Stimulation for Neuropathic Eye Pain

NCT05931250 | Unknown

• 1 other identifier: 20220727401
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Pain; Neuropathy, Optic; Cerebral Injury

Outcome Measures

Primary Outcomes (16)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Change from baseline pupil diameter in millimeters at 1 week

  Minimum and maximum pupil diameter in millimeters

  through treament completion, 1 week

• Change from baseline pupil velocity in millimeters per second at 1 week

  Pupil change velocity in millimeters per second

  through treament completion, 1 week

• Change from baseline pupil latency in milliseconds at 1 week

  Pupil latency latency in milliseconds

  through treament completion, 1 week

Secondary Outcomes (1)

• Treatment compliance rate

  through study completion, 1 year

Other Outcomes (2)

• Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting adherence to treatment protocol

  through study completion, 1 year

• Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting change in pain (Numerical Rating Scale)

  through study completion, 1 year

Study Arms (2)

Transcranial alternating current stimulation

EXPERIMENTAL

Transcranial alternating current stimulation (tACS) device using 50x70 mm electrodes that are placed bilaterally between EEG coordinates C3/C5 for left hemisphere and C4/C6 for right hemisphere (corresponding to S1 and M1 of the eye). The alternating current electrodes are in-phase and have the same peak to peak stimulation 3mA, for 30 minutes duration at 10Hz. An impedance value under 15 ohms is required at all times to ensure patient comfort and safety.

Device: DC-Stimulator Plus (NeuroConn GmbH, Germany)

Transcranial direct current stimulation

EXPERIMENTAL

Transcranial direct current stimulation (tDCS) device using 50x70 mm electrodes that has the anodal electrode placed contralateral to most prominent ocular pain or, in the case of bilateral pain symptoms, contralateral to the dominant hand between EEG coordinates C3/C5 for left hemisphere and C4/C6 for right hemisphere (corresponding to S1 and M1 of the eye), and the cathode placed on the patient's upper arm. A current peaking at 3mA will ramp up for 20 secs and be delivered for a total of 20 minutes, thereafter, ramping down for 20s. An impedance value under 15 ohms is required at all times to ensure patient comfort and safety.

Device: Sooma direct current stimulator (Sooma, Finland)

Interventions

DC-Stimulator Plus (NeuroConn GmbH, Germany) DEVICE

Transcranial alternating current stimulation

Transcranial alternating current stimulation

Sooma direct current stimulator (Sooma, Finland) DEVICE

Transcranial direct current stimulation

Transcranial direct current stimulation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neil Lagali: lead
• Linkoeping University: collaborator

Study Sites (1)

Eye Clinic, University Hospital in Linköping

Linköping, Other / Non-US, 58183, Sweden

RECRUITING

Related Publications (3)

• 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.

  PMID: 27089999 BACKGROUND

• 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.

  PMID: 30883524 BACKGROUND

• 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.

  PMID: 29283468 BACKGROUND

MeSH Terms

Conditions

Eye Pain; Optic Nerve Diseases; Brain Injuries

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Cranial Nerve Diseases; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Neil Lagali, PhD

  RegionÖstergötland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil Lagali, PhD

CONTACT

+4613286680; neil.lagali@liu.se

Magnus Thordstein, MD

CONTACT

magnus.thordstein@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Professor

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 5, 2023
• Study Start: June 16, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)