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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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: 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.
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.
- Change in VAS (Visual Ananlof Scale) for pain assessment [ Time Frame: 1 month ]using an validated score 0 (lowest) to 10 (highest)
- 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.
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
|Contact: Osnat Granotemail@example.com|
|Principal Investigator:||Motti Ratmansky||Loewenstein Rehabilition Center|