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

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ClinicalTrials.gov Identifier: NCT01226082
Recruitment Status : Unknown
Verified October 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 21, 2010
Last Update Posted : October 21, 2010
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Transcranial Direct Current Stimulation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Transcranial Direct Current Stimulation for Chronic Pain on Ophthalmologic Parameters
Study Start Date : November 2010
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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 Name: tDCS




Primary Outcome Measures :
  1. Ophtalmologic examination parameters-visual acuity test, eye movement, field of vision, Tonometry (Intraocular Pressure Testing) [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Pain relief [ Time Frame: 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01226082


Contacts
Contact: Silviu Brill, M.D 972-3-6974477 silviub@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center, Pain Medicine Unit Not yet recruiting
Tel Aviv, Israel
Contact: silviu Brill, M.D    972-3-6974477    silviub@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Silviu Brill, MD Tel-Aviv Sourasky Medical Center

Responsible Party: Pain medicine unit, Tel aviv Sourasky medical center
ClinicalTrials.gov Identifier: NCT01226082     History of Changes
Other Study ID Numbers: TASMC-10-SB-411-CTIL
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: October 21, 2010
Last Verified: October 2010

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