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

Chronic Pain Clinical Trial

— tDCS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01226082
• Other study ID #: TASMC-10-SB-411-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: October 10, 2010
• Last updated: October 20, 2010
• Start date: November 2010
• Est. completion date: November 2011

Study information

• Verified date: October 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Silviu Brill, M.D
• Phone: 972-3-6974477
• Email: silviub[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Transcranial Direct Current Stimulation
Patients will recieve tDCS in a 5-day period of treatment

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center, Pain Medicine Unit	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ophtalmologic examination parameters-visual acuity test, eye movement, field of vision, Tonometry (Intraocular Pressure Testing)		5 days	No
Secondary	Pain relief		5 days	No