tDCS to Treat Hemiplegic Shoulder Pain

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: Intervention; Device: Sham

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Osnat Granot; Phone Number: 97297709957; Email: osnatel@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VAS (Visual Ananlof Scale) for pain assessment	using an validated score 0 (lowest) to 10 (highest)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Loewenstein Hospital
• Investigators: Principal Investigator: Motti Ratmansky, Loewenstein Rehabilition Center

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: October 9, 2016
• First Submitted That Met QC Criteria: October 10, 2016
• First Posted (Estimate): October 11, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Stroke; transcranial Direct Current Stimulation; Hemiplegic Shoulder Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: loe160033ctil

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No