ClinicalTrials.gov
ClinicalTrials.gov Menu

Transcranial Direct Current Stimulation for Chronic Pain Relief

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Chrronic Pain Patients Device: direct current stimulation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation for Chronic Pain Relief
Study Start Date : November 2010
Estimated Primary Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Arm Intervention/treatment
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.
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
Sham Comparator: sham stimulation 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



Primary Outcome Measures :
  1. Pain relief [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Avaluation of tDCS treatment for chronic pain on disability, depression, anxiety, and cognition of treated patients. [ Time Frame: 5 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Responsible Party: Silviu Brill MD, Tel aviv Sourasky medical center
ClinicalTrials.gov Identifier: NCT01220323     History of Changes
Other Study ID Numbers: TASMC-10-SB-396-CTIL
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: October 2010

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