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Completed

NCT Number: NCT01575002

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

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.

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Key information

Conditions

Corneal Pain Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

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: 1x1 direct current stimulator; Soterix Medical

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Official study title

Neural Correlates of Pain-related Cognitive Processing in Chronic Pain of the Cornea: an ERP and Electrical Stimulation Study.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 10, 2012
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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