- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01575002
Effects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain
April 23, 2020 updated by: Felipe Fregni, Spaulding Rehabilitation Hospital
Neural Correlates of Pain-related Cognitive Processing in Chronic Pain of the Cornea: an ERP and Electrical Stimulation Study.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Spaulding Rehabilitation Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Contraindications to tDCS
- Metal in the head
- Implanted brain medical devices
- Pregnant at time of enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Active tDCS
Subjects will undergo 20 minutes of active tDCS stimulation.
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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 Names:
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SHAM_COMPARATOR: Sham tDCS
Subjects will undergo 20 minutes of sham tDCS stimulation.
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in pain scales
Time Frame: Measured for approximately 2 weeks
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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.
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Measured for approximately 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Measured for approximately 2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (ACTUAL)
September 1, 2015
Study Completion (ACTUAL)
September 1, 2015
Study Registration Dates
First Submitted
February 8, 2012
First Submitted That Met QC Criteria
April 9, 2012
First Posted (ESTIMATE)
April 10, 2012
Study Record Updates
Last Update Posted (ACTUAL)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 23, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-p-001902
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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