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

This study is currently recruiting participants.
Verified April 2013 by Spaulding Rehabilitation Hospital
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01575002
First received: February 8, 2012
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  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 Phase
Corneal Pain
Chronic Pain
Neuropathic Pain
 Device: Transcranial Direct Current Stimulation (tDCS)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Changes in pain scales [ Time Frame: Measured for approximately 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 70
Study Start Date: January 2012
Estimated Primary Completion Date: January 2014 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575002

Contacts
Contact: Felipe Fregni, MD PhD MPH 617-573-2326 ffregni@partners.org
Contact: Kayleen M Weaver, BA 617-573-2196 kmweaver@partners.org

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

No publications provided

Responsible Party: Felipe Fregni, Associate Professor, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01575002     History of Changes
Other Study ID Numbers: 2011-p-001902
Study First Received: February 8, 2012
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
transcranial stimulation
direct current stimulation

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

ClinicalTrials.gov processed this record on June 18, 2013