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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
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chrronic Pain Patients

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 6, 2010
    Last Updated
    October 11, 2010
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    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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