An interventional study of Intervention and Sham in Stroke, sponsored by Loewenstein Hospital. Status unknown. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-07-18.
Sponsored by Loewenstein Hospital · Not applicable, Interventional, and Treatment
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.
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.
7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Loewenstein Hospital is the lead sponsor of 25 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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
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
Patients hospitalized in the Loewenstein department of neurologic rehabilitation after first clinical stroke who do not have hemiplegic shoulder pain.
Device: neuroConn\_CE\_DC-STIMULATOR. Anodal stimulation to affected hemisphere.
no meaningful stimulation will be given.
Change in VAS (Visual Ananlof Scale) for pain assessment
using an validated score 0 (lowest) to 10 (highest)
Time frame: 1 month
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.
Time frame: 1 month
No study locations are listed for this record.
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Loewenstein Hospital