StrokeNCT02929784
tDCS to Treat Hemiplegic Shoulder Pain
A study testing Intervention in people with Stroke, run by Loewenstein Hospital.
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Shoulder pain predating the stroke
- Epilepsy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Stroke
- Being tested
- Intervention, Sham
- Keywords
- Hemiplegic Shoulder Pain, transcranial Direct Current Stimulation, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDevice
Device: neuroConn_CE_DC-STIMULATOR. Anodal stimulation to affected hemisphere.
ShamDevice
no meaningful stimulation will be given.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Device: Intervention |
| Sham | Sham comparator | 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. Receives: Device: Sham |
| no HSP | No intervention | Patients hospitalized in the Loewenstein department of neurologic rehabilitation after first clinical stroke who do not have hemiplegic shoulder pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS (Visual Ananlof Scale) for pain assessment
using an validated score 0 (lowest) to 10 (highest)
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study start1 Nov 2018 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Motti Ratmansky, MD, Loewenstein Hospital
- Investigators
- Motti Ratmansky, Principal investigator, Loewenstein Rehabilition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929784
- Sponsor's protocol ID
- loe160033ctil
- Status last verified
- Jul 2018
- First submitted
- 9 Oct 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesing Hemiplegic Shoulder Pain and the Use of tDCS to Treat This Pain
- ClinicalTrials.gov ID
- NCT02929784
- Acronym / sponsor ID
- loe160033ctil
- Conditions
- Stroke
- Keywords
- Hemiplegic Shoulder Pain, transcranial Direct Current Stimulation, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: InterventionElectrode 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. |
| Sham | Sham comparator | Device: ShamThe 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. |
| no HSP | No intervention | –Patients hospitalized in the Loewenstein department of neurologic rehabilitation after first clinical stroke who do not have hemiplegic shoulder pain. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Shoulder pain predating the stroke
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionDevice: neuroConn_CE_DC-STIMULATOR. Anodal stimulation to affected hemisphere. | Device | Intervention |
| Shamno meaningful stimulation will be given. | Device | Sham |
Primary outcome
Change in VAS (Visual Ananlof Scale) for pain assessment
Time frame: 1 month
using an validated score 0 (lowest) to 10 (highest)
1 secondary outcome
Change in Fugl-Meyer assessment
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Motti Ratmansky principal investigator
Loewenstein Rehabilition Center
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Stroke, run by Loewenstein Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osnat Granot (97297709957, osnatel@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VAS (Visual Ananlof Scale) for pain assessment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.