tDCS to Treat Hemiplegic Shoulder Pain

Stroke Clinical Trial

Official title:

Assesing Hemiplegic Shoulder Pain and the Use of tDCS to Treat This Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02929784
• Other study ID #: loe160033ctil
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: July 2018
• Source: Loewenstein Hospital
• Contact: Osnat Granot
• Phone: 97297709957
• Email: osnatel[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain
• Stroke

Intervention

Device:
• Intervention
Device: neuroConn_CE_DC-STIMULATOR. Anodal stimulation to affected hemisphere.
• Sham
no meaningful stimulation will be given.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Loewenstein Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VAS (Visual Ananlof Scale) for pain assessment	using an validated score 0 (lowest) to 10 (highest)	1 month
Secondary	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.	1 month