The Effect of Transcranial Direct Current Stimulation for Chronic Pain on Ophthalmologic Parameters (tDCS)

October 20, 2010 updated by: Tel-Aviv Sourasky Medical Center
tDCS is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to modulate the level of cortical excitability.Several studies have demonstrated that tDCS applied over the sensory-motor cortex has been able to decrease pain sensation and to increase pain threshold in healthy subjects and in chronic pain patients. The aim of this study was to test whether daily sessions of anodal tDCS repeated for 5 consecutive days may be effective in reducing pain in a large number of chronic pain patients. The cathode is usually applied over the right forhead above the eye. The aim of the study is to test whether daily sessions of tDCS repeated for 5 consecutive days will influence on ophthalmologic parametrs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

tDCS is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to modulate the level of cortical excitability.Several studies have demonstrated that tDCS applied over the sensory-motor cortex has been able to decrease pain sensation and to increase pain threshold in healthy subjects and in chronic pain patients. The aim of this study was to test whether daily sessions of anodal tDCS repeated for 5 consecutive days may be effective in reducing pain in a large number of chronic pain patients. The cathode is usually applied over the right forhead above the eye. The aim of the study is to test whether daily sessions of tDCS repeated for 5 consecutive days will influence on ophthalmologic parametrs.

Patients will recieve tDCS in a 5-day period of treatment. The participants will go through full ophtalmologic examination before and after the treatmnet In addition to the ophtalmologic examination Pain will be measured using visual analog scale (VAS) for pain and the short form McGill questionnaire (SF-MPQ). Disability will be measured using the ( Pain Disability Index (PDI) of Life-54 scale (MSQoL-54). Depressive symptoms and anxiety will also be evaluated using the Center for Epidemiological Studies-Depression Scale and the State-trait Anxiety Inventory (STAI). Cognitive function will be mesured using minimental test.

Study Type

Interventional

Enrollment (Anticipated)

30

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

  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center, Pain Medicine Unit

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

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who suffer from chronic pain VAS>4

Exclusion Criteria:

  • pregnancy
  • scalp lacerations
  • history of seizures
  • metal implants in the head
  • heart pace maker
  • ophthalmologic disease.
  • The presence of deep brain stimulation system

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial Direct Current Stimulation
Device: Transcranial Direct Current Stimulation
Patients will recieve tDCS in a 5-day period of treatment
Other Names:
  • tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ophtalmologic examination parameters-visual acuity test, eye movement, field of vision, Tonometry (Intraocular Pressure Testing)
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain relief
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

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

November 1, 2010

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

October 10, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 21, 2010

Study Record Updates

Last Update Posted (Estimate)

October 21, 2010

Last Update Submitted That Met QC Criteria

October 20, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-10-SB-411-CTIL

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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