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tDCS to Treat Hemiplegic Shoulder Pain

Primary Purpose

Stroke

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

About this trial

This is an interventional treatment trial for Stroke focused on measuring Hemiplegic Shoulder Pain, transcranial Direct Current Stimulation, Stroke

Eligibility Criteria

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

Inclusion Criteria:

  • Patients hospitalized in the department of neurologic rehabilitation of Loewenstein Rehabilitation Center after first clinical stroke.
  • Able to understand and comply with basic instructions
  • Signed an informed consent form
  • Hebrew speaking

Exclusion Criteria:

  • Shoulder pain predating the stroke
  • Epilepsy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    No Intervention

    Arm Label

    Intervention

    Sham

    no HSP

    Arm Description

    Electrode positioning will be determined according to the EEG 10-20 international system for EEG electrode placement: Affected hemisphere anodal stimulation of the hand area of the primary motor cortex (C3/C4), Intensity of 2 mA (milliampere) for duration of 20 minutes. A total of 10 sessions: 5 sessions a week for 2 weeks.

    The stimulator will be turned on for only a very short duration of time (msec) no meaningful stimulation is believed to be administered in such a way.

    Patients hospitalized in the Loewenstein department of neurologic rehabilitation after first clinical stroke who do not have hemiplegic shoulder pain.

    Outcomes

    Primary Outcome Measures

    Change in VAS (Visual Ananlof Scale) for pain assessment
    using an validated score 0 (lowest) to 10 (highest)

    Secondary Outcome Measures

    Change in Fugl-Meyer assessment
    The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.

    Full Information

    First Posted
    October 9, 2016
    Last Updated
    July 16, 2018
    Sponsor
    Loewenstein Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02929784
    Brief Title
    tDCS to Treat Hemiplegic Shoulder Pain
    Official Title
    Assesing Hemiplegic Shoulder Pain and the Use of tDCS to Treat This Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2018 (Anticipated)
    Primary Completion Date
    November 1, 2020 (Anticipated)
    Study Completion Date
    November 1, 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
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to investigate the possibility of treating Hemiplegic Shoulder Pain (HSP) using transcranial direct current stimulation (tDCS) in patients following stroke. The secondary aims are to see if this treatment affects motor function of the upper limb, to asses the different types of HSP and whether there is any correlation to the location and extent of the stroke.
    Detailed Description
    Hemiplegic Shoulder Pain (HSP) is a common entity following stroke. It's prevalence varies between studies, probably because it includes many etiologies and there is no one way of diagnosis. HSP delays rehabilitation, elongates hospitalization time and reduces quality of life. Currently there is no one reccomended treatment for HSP. Weak transcranial direct current stimulation (tDCS) induces persisting excitability changes in the human motor cortex. this effect depends on the stimulation polarity and is specific to the site of stimulation. Interacting with cortical activity, by means of cortical stimulation, can improve the rehabilitation potential of neurologic patients. In this respect, preliminary evidence suggests that cortical stimulation may play a role in treating aphasia, unilateral neglect, and chronic pain disorders. In this tDCS study the investigator uses one anode and one cathode electrode placed over the scalp to modulate a particular area of the central nervous system (CNS). The stimulation is administered via the neuroConn DC.Stimulator. The DC-STIMULATOR is a micro-processor-controlled constant current source. The DCSTIMULATOR is a CE-certified medical device for conducting non-invasive transcranial direct current stimulation (tDCS) on people.Electrode positioning is determined according to the International EEG 10-20 System.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Hemiplegic Shoulder Pain, transcranial Direct Current Stimulation, Stroke

    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
    Arm Type
    Experimental
    Arm Description
    Electrode positioning will be determined according to the EEG 10-20 international system for EEG electrode placement: Affected hemisphere anodal stimulation of the hand area of the primary motor cortex (C3/C4), Intensity of 2 mA (milliampere) for duration of 20 minutes. A total of 10 sessions: 5 sessions a week for 2 weeks.
    Arm Title
    Sham
    Arm Type
    Sham Comparator
    Arm Description
    The stimulator will be turned on for only a very short duration of time (msec) no meaningful stimulation is believed to be administered in such a way.
    Arm Title
    no HSP
    Arm Type
    No Intervention
    Arm Description
    Patients hospitalized in the Loewenstein department of neurologic rehabilitation after first clinical stroke who do not have hemiplegic shoulder pain.
    Intervention Type
    Device
    Intervention Name(s)
    Intervention
    Intervention Description
    Device: neuroConn_CE_DC-STIMULATOR. Anodal stimulation to affected hemisphere.
    Intervention Type
    Device
    Intervention Name(s)
    Sham
    Intervention Description
    no meaningful stimulation will be given.
    Primary Outcome Measure Information:
    Title
    Change in VAS (Visual Ananlof Scale) for pain assessment
    Description
    using an validated score 0 (lowest) to 10 (highest)
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Change in Fugl-Meyer assessment
    Description
    The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients hospitalized in the department of neurologic rehabilitation of Loewenstein Rehabilitation Center after first clinical stroke. Able to understand and comply with basic instructions Signed an informed consent form Hebrew speaking Exclusion Criteria: Shoulder pain predating the stroke Epilepsy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Osnat Granot
    Phone
    97297709957
    Email
    osnatel@clalit.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Motti Ratmansky
    Organizational Affiliation
    Loewenstein Rehabilition Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    tDCS to Treat Hemiplegic Shoulder Pain

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