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Transcranial Direct Current Stimulation for Chronic Pain Relief

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ClinicalTrials.gov Identifier: NCT01220323
Recruitment Status : Unknown
Verified October 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 13, 2010
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

October 6, 2010
October 13, 2010
October 13, 2010
November 2010
November 2011   (Final data collection date for primary outcome measure)
Pain relief [ Time Frame: 5 days ]
Same as current
No Changes Posted
Avaluation of tDCS treatment for chronic pain on disability, depression, anxiety, and cognition of treated patients. [ Time Frame: 5 days ]
Same as current
Not Provided
Not Provided
 
Transcranial Direct Current Stimulation for Chronic Pain Relief
Transcranial Direct Current Stimulation for Chronic Pain Relief
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Chrronic Pain Patients
Device: direct current stimulation
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
  • Active Comparator: direct current stimulation
    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: Device: direct current stimulation
  • Sham Comparator: sham stimulation
    Intervention: Device: direct current stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
Same as current
Not Provided
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01220323
TASMC-10-SB-396-CTIL
Not Provided
Not Provided
Not Provided
Silviu Brill MD, Tel aviv Sourasky medical center
Tel-Aviv Sourasky Medical Center
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP