We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01575002
First Posted: April 10, 2012
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
  Purpose
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.

Condition Intervention
Corneal Pain Chronic Pain Neuropathic Pain Device: Transcranial Direct Current Stimulation (tDCS)

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Felipe Fregni, Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 26
Study Start Date: January 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active tDCS
Subjects will undergo 20 minutes of active 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
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Felipe Fregni, MD PHD MPH Spaulding Rehabilitation Hospital
  More Information

Responsible Party: Felipe Fregni, Associate Professor, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01575002     History of Changes
Other Study ID Numbers: 2011-p-001902
First Submitted: February 8, 2012
First Posted: April 10, 2012
Last Update Posted: March 21, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:
transcranial stimulation
direct current stimulation

Additional relevant MeSH terms:
Chronic Pain
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases