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tDCS and VI to Treat Neuropathic Pain and Function in SCI

Primary Purpose

SCI - Spinal Cord Injury

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tDCS+VI
tDCS Sham+VI Sham
Sponsored by
Loewenstein Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SCI - Spinal Cord Injury focused on measuring tDCS (trans cranial direct current stimulation), Visual illusion, Neuropathic pain, Spinal cord Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. patients hospitalized in spinal cord rehabilitation department
  2. neuropathic pain following spinal cord injury
  3. able to seat on a wheel chair
  4. able to understand and comply with basic instructions
  5. Hebrew speakers

Exclusion Criteria:

  1. epilepsy
  2. pregnancy
  3. non-neuropathic pain
  4. medical condition that affect cognitive functioning
  5. medical condition other then the spinal cord injury that affect functioning

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    intervention tDCS+VI

    tDCS Sham+VI Sham

    Arm Description

    The anode will be placed over C3-C4 (EEG 10/20 system) to target M1 and the cathode over the contralateral supraorbital area. The stimulation will apply to the hemisphere which contralateral to the more painful hemi body. 2mA will be delivered over 20 min via neuroConn DC stimulator combined with video presenting walking legs. A total of 10 sessions (5 per week) will be administrated at the same manner.

    The stimulation will be turned on for only short duration (up to 30 sec), the video film will contains graphical illustrations or nature movie without human movement.

    Outcomes

    Primary Outcome Measures

    change in SCIM 3 (scale)
    spinal cord independence measure

    Secondary Outcome Measures

    change in VAS (Visual Analog Scale)
    reported subjective pain scale
    change in BPI (Brief Pain Inventory)

    Full Information

    First Posted
    January 29, 2017
    Last Updated
    February 9, 2017
    Sponsor
    Loewenstein Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03052244
    Brief Title
    tDCS and VI to Treat Neuropathic Pain and Function in SCI
    Official Title
    tDCS Stimulation Combined With VI as a Possible Therapy for Enhancing Functional Ability in SCI With Neuropathic Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 15, 2017 (Anticipated)
    Primary Completion Date
    March 15, 2020 (Anticipated)
    Study Completion Date
    March 15, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Loewenstein Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) will be applied for patient who suffer from neuropathic pain following spinal cord injury The tDCS treatment will be coupled with a video of a man walking (creating a visual illusion) in order to enhance functional ability and reduce pain
    Detailed Description
    Non-invasive cortical brain stimulation is a promising method for treating cases of neuropathic pain in patients with spinal cord injury (SCI). Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) appears to modulate cortical excitability and can reduce pain levels following SCI, however its effects remaining for short-term and may not be useful for the rehabilitation progress in these patients. Recent findings suggest that M1 stimulation combined with visual illusion (VI) enhances the reduction in pain which maintain up to 3 month following treatment. The current study aims to reveal whether reduction of neuropathic pain in patients with SCI through tDCS have beneficial effect on functional ability during rehabilitation program. In the present study the investigators will use anodal stimulation of the M1 via neuroConn DC stimulator. Current intensity of 2mA or sham stimulation will be given during 20 min in parallel to a visual illusion of walking legs (or neutral video for sham stimuli).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    SCI - Spinal Cord Injury
    Keywords
    tDCS (trans cranial direct current stimulation), Visual illusion, Neuropathic pain, Spinal cord Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention tDCS+VI
    Arm Type
    Experimental
    Arm Description
    The anode will be placed over C3-C4 (EEG 10/20 system) to target M1 and the cathode over the contralateral supraorbital area. The stimulation will apply to the hemisphere which contralateral to the more painful hemi body. 2mA will be delivered over 20 min via neuroConn DC stimulator combined with video presenting walking legs. A total of 10 sessions (5 per week) will be administrated at the same manner.
    Arm Title
    tDCS Sham+VI Sham
    Arm Type
    Sham Comparator
    Arm Description
    The stimulation will be turned on for only short duration (up to 30 sec), the video film will contains graphical illustrations or nature movie without human movement.
    Intervention Type
    Device
    Intervention Name(s)
    tDCS+VI
    Other Intervention Name(s)
    transcranial direct current stimulation+visual illusion
    Intervention Description
    2mA will be delivered over 20min to M1 via neuroConn DC stimulator combined with video presenting walking legs.
    Intervention Type
    Device
    Intervention Name(s)
    tDCS Sham+VI Sham
    Other Intervention Name(s)
    Sham
    Intervention Description
    2mA will be delivered up to 30 sec to M1 via neuroConn DC stimulator combined with video presenting graphical illustration or nature movie for total duration of 20 min.
    Primary Outcome Measure Information:
    Title
    change in SCIM 3 (scale)
    Description
    spinal cord independence measure
    Time Frame
    up to 7 day before and following the treatment
    Secondary Outcome Measure Information:
    Title
    change in VAS (Visual Analog Scale)
    Description
    reported subjective pain scale
    Time Frame
    up to 7 day before and following the treatment
    Title
    change in BPI (Brief Pain Inventory)
    Time Frame
    up to 24h before and following the treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients hospitalized in spinal cord rehabilitation department neuropathic pain following spinal cord injury able to seat on a wheel chair able to understand and comply with basic instructions Hebrew speakers Exclusion Criteria: epilepsy pregnancy non-neuropathic pain medical condition that affect cognitive functioning medical condition other then the spinal cord injury that affect functioning
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rotem Gur, Ph.D
    Phone
    97297709170
    Email
    rotemgu@clalit.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Motti Ratmansky, MD
    Phone
    97297709102
    Email
    mottir@clalit.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Motti Ratmansky, MD
    Organizational Affiliation
    Loewenstein Rehabilitation Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    tDCS and VI to Treat Neuropathic Pain and Function in SCI

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