Chronic Pain, Corneal Pain, Neuropathic Pain
Conditions
Keywords
transcranial stimulation, direct current stimulation
Brief summary
In this study the investigators aim to examine the effects of Transcranial Direct Current Stimulation (tDCS) on pain levels as well as the changes in cognitive (thought) processing in individuals with chronic pain of the cornea -- and also compared with healthy controls.
Interventions
DEVICETranscranial Direct Current Stimulation (tDCS)
Subjects will undergo 2 sessions of 20 minutes of tDCS stimulation (either active or sham)in a randomized order - each session will be separated by at least one week to prevent carry-over effects.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
(for all subjects): 1. Provide informed consent to participate in the study; 2. 18 to 65 years old; Additional Inclusion Criteria for Subjects with Chronic Corneal Pain: 1. Corneal pain for six months or more; 2. Referral from a corneal specialist (Dr. Perry Rosenthal) with refractoriness to conventional ophthalmologic treatments for corneal pain such as local topical medications and soft bandage contact lenses; 3. Report a Visual Analogue Scale (VAS) for pain of 4 or greater in the previous 3 weeks;
Exclusion criteria
(for all subjects): 1. History of alcohol or substance abuse within the last 6 months as self-reported; 2. Diagnosis of any neurological diseases (such as epilepsy); 3. Episodes of seizures within the last 6 months; 4. Unexplained loss of consciousness 5. Use of carbamazepine or neuropsychotropic drugs 6. Contraindications to tDCS * Metal in the head * Implanted brain medical devices 7. Pregnant at time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pain scales | Measured for approximately 2 weeks | We will measure changes in the visual analogue scale (VAS) for pain, and also measure pain threshold (using an algometer) before and after each stimulation session. We will compare the measurements from before stimulation to after stimulation, in each scheduled session, as this study is measuring the effects of a single session of tDCS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in EEG measurements | Measured for approximately 2 weeks | We will measure changes in event related potentials (ex. P300, mismatch negativity) recorded via electroencephalography (EEG) before and after each stimulation session. We will compare the measurements from before stimulation to after stimulation, in each scheduled session, as this study is measuring the effects of a single session of tDCS. |
Countries
United States
Outcome results
None listed