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tDCS to Treat Hemiplegic Shoulder Pain

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ClinicalTrials.gov Identifier: NCT02929784
Recruitment Status : Not yet recruiting
First Posted : October 11, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Motti Ratmansky, MD, Loewenstein Hospital

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.


Condition or disease Intervention/treatment Phase
Stroke Device: Intervention Device: Sham Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assesing Hemiplegic Shoulder Pain and the Use of tDCS to Treat This Pain
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Arm Intervention/treatment
Experimental: Intervention
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.
Device: Intervention
Device: neuroConn_CE_DC-STIMULATOR. Anodal stimulation to affected hemisphere.

Sham Comparator: Sham
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.
Device: Sham
no meaningful stimulation will be given.

No Intervention: no HSP
Patients hospitalized in the Loewenstein department of neurologic rehabilitation after first clinical stroke who do not have hemiplegic shoulder pain.



Primary Outcome Measures :
  1. Change in VAS (Visual Ananlof Scale) for pain assessment [ Time Frame: 1 month ]
    using an validated score 0 (lowest) to 10 (highest)


Secondary Outcome Measures :
  1. Change in Fugl-Meyer assessment [ Time Frame: 1 month ]
    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.



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929784


Contacts
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Contact: Osnat Granot 97297709957 osnatel@clalit.org.il

Sponsors and Collaborators
Loewenstein Hospital
Investigators
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Principal Investigator: Motti Ratmansky Loewenstein Rehabilition Center

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Responsible Party: Motti Ratmansky, MD, Head of pain unit, Loewenstein Hospital, Loewenstein Hospital
ClinicalTrials.gov Identifier: NCT02929784     History of Changes
Other Study ID Numbers: loe160033ctil
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Motti Ratmansky, MD, Loewenstein Hospital:
Hemiplegic Shoulder Pain
transcranial Direct Current Stimulation
Stroke
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms