CClinicalTrials.gg
CompletedNCT01575002Updated Apr 24, 2020

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

An interventional study of Transcranial Direct Current Stimulation (tDCS) in Corneal Pain, Chronic Pain and Neuropathic Pain, sponsored by Spaulding Rehabilitation Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-24.

Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Corneal Pain
  • Chronic Pain
  • Neuropathic Pain

Keywords

  • transcranial stimulation
  • direct current stimulation
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 26 is below the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Spaulding Rehabilitation Hospital is the lead sponsor of 114 studies on the registry; 26 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Active tDCS

    Subjects will undergo 20 minutes of active tDCS stimulation.

    Device: Transcranial Direct Current Stimulation (tDCS)

  • Sham comparator
    Sham tDCS

    Subjects will undergo 20 minutes of sham tDCS stimulation.

    Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

  • DeviceTranscranial 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.

    Also known as: 1x1 direct current stimulator; Soterix Medical

06

What researchers measure

Primary outcomes

  1. Changes in pain scales

    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.

    Time frame: Measured for approximately 2 weeks

Secondary outcomes

  1. Changes in EEG measurements

    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.

    Time frame: Measured for approximately 2 weeks

07

Study locations

1 site
  • Spaulding Rehabilitation Hospital
    Boston, Massachusetts 02114, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01575002
Lead sponsor
Spaulding Rehabilitation Hospital
Responsible party
Felipe Fregni (Associate Professor, Spaulding Rehabilitation Hospital) — Principal investigator
First posted
Apr 10, 2012
Start date
Jan 2012
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Apr 24, 2020

Study contacts

Felipe Fregni, MD PHD MPH
principal investigator · Spaulding Rehabilitation Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion