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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01226082
First received: October 10, 2010
Last updated: October 20, 2010
Last verified: October 2010
  Purpose

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 Intervention
Chronic Pain
Device: Transcranial Direct Current Stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Transcranial Direct Current Stimulation for Chronic Pain on Ophthalmologic Parameters

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Ophtalmologic examination parameters-visual acuity test, eye movement, field of vision, Tonometry (Intraocular Pressure Testing) [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain relief [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcranial Direct Current Stimulation Device: Transcranial Direct Current Stimulation
Patients will recieve tDCS in a 5-day period of treatment
Other Name: tDCS

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: October 10, 2010
Last Updated: October 20, 2010
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on October 28, 2014