Transcranial Direct Current Stimulation for Chronic Pain Relief
Primary Purpose
Chrronic Pain Patients
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
direct current stimulation
direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chrronic Pain Patients
Eligibility Criteria
Inclusion Criteria: over 18 chronic pain patients VAS > 4 Exclusion Criteria: pregnancy scalp lacerations History of seizures metal implants in the head heart pace maker
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
direct current stimulation
sham stimulation
Arm Description
The participants will be divided to 2 groups of 50 each. One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation. X week later the groups will switch to the other arm.
Outcomes
Primary Outcome Measures
Pain relief
Secondary Outcome Measures
Avaluation of tDCS treatment for chronic pain on disability, depression, anxiety, and cognition of treated patients.
Full Information
NCT ID
NCT01220323
First Posted
October 6, 2010
Last Updated
October 11, 2010
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01220323
Brief Title
Transcranial Direct Current Stimulation for Chronic Pain Relief
Official Title
Transcranial Direct Current Stimulation for Chronic Pain Relief
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
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
5. Study Description
Brief Summary
In the present study, the investigators intend to investigate whether anodal transcranial direct current stimulation (tDCS) may be effective in reducing pain in chronic pain patients.
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.
Patients will receive sham tDCS or real tDCS in a 5-day period of treatment in a randomized, sham controlled study. The participants will be divided to 2 groups of 50 each. One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation. X week later the groups will switch to the other arm.
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. Evaluations will be performed at baseline, immediately after the end of treatment, and once a week during a 3-week follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chrronic Pain Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
direct current stimulation
Arm Type
Active Comparator
Arm Description
The participants will be divided to 2 groups of 50 each. One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation. X week later the groups will switch to the other arm.
Arm Title
sham stimulation
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
direct current stimulation
Intervention Description
Patients will receive sham tDCS or real tDCS in a 5-day period of treatment in a randomized, sham controlled study. The participants will be divided to 2 groups of 50 each. One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation. X week later the groups will switch to the other arm
Intervention Type
Device
Intervention Name(s)
direct current stimulation
Intervention Description
Patients will receive sham tDCS or real tDCS in a 5-day period of treatment in a randomized, sham controlled study. The participants will be divided to 2 groups of 50 each. One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation. X week later the groups will switch to the other arm
Primary Outcome Measure Information:
Title
Pain relief
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Avaluation of tDCS treatment for chronic pain on disability, depression, anxiety, and cognition of treated patients.
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:
over 18
chronic pain patients VAS > 4
Exclusion Criteria:
pregnancy
scalp lacerations
History of seizures
metal implants in the head
heart pace maker
12. IPD Sharing Statement
Learn more about this trial
Transcranial Direct Current Stimulation for Chronic Pain Relief
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