tDCS to Treat Hemiplegic Shoulder Pain

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Sham Device
    Intervention Desc: no meaningful stimulation will be given.
    ARM 1: Kind: Experimental
    Label: Sham
    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.
  • Intervention Device
    Intervention Desc: Device: neuroConn_CE_DC-STIMULATOR. Anodal stimulation to affected hemisphere.
    ARM 1: Kind: Experimental
    Label: Intervention
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in VAS assessment 1 month No
Secondary Change in Fugl-Meyer assessment 1 month No

Sponsors