Alternating and Direct Current Stimulation for Neuropathic Eye Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Brief Summary sufficient

Conditions

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Eye Pain Neuropathy, Optic Cerebral Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcranial alternating current stimulation

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.

Group Type EXPERIMENTAL

DC-Stimulator Plus (NeuroConn GmbH, Germany)

Intervention Type DEVICE

Transcranial alternating current stimulation

Transcranial direct current stimulation

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.

Group Type EXPERIMENTAL

Sooma direct current stimulator (Sooma, Finland)

Intervention Type DEVICE

Transcranial direct current stimulation

Interventions

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DC-Stimulator Plus (NeuroConn GmbH, Germany)

Transcranial alternating current stimulation

Intervention Type DEVICE

Sooma direct current stimulator (Sooma, Finland)

Transcranial direct current stimulation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No