The Effect of Transcranial Direct Current Stimulation for Chronic Pain on Ophthalmologic Parameters (tDCS)
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility 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
Sites / Locations
- Tel Aviv Sourasky Medical Center, Pain Medicine Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcranial Direct Current Stimulation
Arm Description
Outcomes
Primary Outcome Measures
Ophtalmologic examination parameters-visual acuity test, eye movement, field of vision, Tonometry (Intraocular Pressure Testing)
Secondary Outcome Measures
Pain relief
Full Information
NCT ID
NCT01226082
First Posted
October 10, 2010
Last Updated
October 20, 2010
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01226082
Brief Title
The Effect of Transcranial Direct Current Stimulation for Chronic Pain on Ophthalmologic Parameters
Acronym
tDCS
Official Title
The Effect of Transcranial Direct Current Stimulation for Chronic Pain on Ophthalmologic Parameters
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcranial Direct Current Stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Patients will recieve tDCS in a 5-day period of treatment
Primary Outcome Measure Information:
Title
Ophtalmologic examination parameters-visual acuity test, eye movement, field of vision, Tonometry (Intraocular Pressure Testing)
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Pain relief
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silviu Brill, M.D
Phone
972-3-6974477
Email
silviub@tasmc.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silviu Brill, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center, Pain Medicine Unit
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
silviu Brill, M.D
Phone
972-3-6974477
Email
silviub@tasmc.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
The Effect of Transcranial Direct Current Stimulation for Chronic Pain on Ophthalmologic Parameters
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