tDCS to Treat Hemiplegic Shoulder Pain

NCT ID: NCT02929784

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-11-01

Brief Summary

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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

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Intervention

Intervention Type DEVICE

Device: neuroConn\_CE\_DC-STIMULATOR. Anodal stimulation to affected hemisphere.

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.

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

no meaningful stimulation will be given.

no HSP

Patients hospitalized in the Loewenstein department of neurologic rehabilitation after first clinical stroke who do not have hemiplegic shoulder pain.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention

Device: neuroConn\_CE\_DC-STIMULATOR. Anodal stimulation to affected hemisphere.

Intervention Type DEVICE

Sham

no meaningful stimulation will be given.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loewenstein Hospital

OTHER

Sponsor Role lead

Responsible Party

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Motti Ratmansky, MD

Head of pain unit, Loewenstein Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Motti Ratmansky

Role: PRINCIPAL_INVESTIGATOR

Loewenstein Rehabilition Center

Central Contacts

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Osnat Granot

Role: CONTACT

97297709957

Other Identifiers

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loe160033ctil

Identifier Type: -

Identifier Source: org_study_id

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