Effects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain
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ClinicalTrials.gov Identifier: NCT01575002 |
Recruitment Status :
Completed
First Posted : April 10, 2012
Last Update Posted : April 24, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Corneal Pain Chronic Pain Neuropathic Pain | Device: Transcranial Direct Current Stimulation (tDCS) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Neural Correlates of Pain-related Cognitive Processing in Chronic Pain of the Cornea: an ERP and Electrical Stimulation Study. |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Active tDCS
Subjects will undergo 20 minutes of active tDCS stimulation.
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Device: Transcranial 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.
Other Name: 1x1 direct current stimulator; Soterix Medical |
Sham Comparator: Sham tDCS
Subjects will undergo 20 minutes of sham tDCS stimulation.
|
Device: Transcranial 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.
Other Name: 1x1 direct current stimulator; Soterix Medical |
- Changes in pain scales [ Time Frame: 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.
- Changes in EEG measurements [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria (for all subjects):
- Provide informed consent to participate in the study;
- 18 to 65 years old;
Additional Inclusion Criteria for Subjects with Chronic Corneal Pain:
- Corneal pain for six months or more;
- 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;
- Report a Visual Analogue Scale (VAS) for pain of 4 or greater in the previous 3 weeks;
Exclusion Criteria (for all subjects):
- History of alcohol or substance abuse within the last 6 months as self-reported;
- Diagnosis of any neurological diseases (such as epilepsy);
- Episodes of seizures within the last 6 months;
- Unexplained loss of consciousness
- Use of carbamazepine or neuropsychotropic drugs
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Contraindications to tDCS
- Metal in the head
- Implanted brain medical devices
- Pregnant at time of enrollment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575002
United States, Massachusetts | |
Spaulding Rehabilitation Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Felipe Fregni, MD PHD MPH | Spaulding Rehabilitation Hospital |
Responsible Party: | Felipe Fregni, Associate Professor, Spaulding Rehabilitation Hospital |
ClinicalTrials.gov Identifier: | NCT01575002 |
Other Study ID Numbers: |
2011-p-001902 |
First Posted: | April 10, 2012 Key Record Dates |
Last Update Posted: | April 24, 2020 |
Last Verified: | April 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
transcranial stimulation direct current stimulation |
Neuralgia Chronic Pain Pain Neurologic Manifestations |
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