tDCS to Treat Hemiplegic Shoulder Pain
Assesing Hemiplegic Shoulder Pain and the Use of tDCS to Treat This Pain
1 other identifier
interventional
100
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Nov 2018
Typical duration for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2016
CompletedFirst Posted
Study publicly available on registry
October 11, 2016
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedJuly 18, 2018
July 1, 2018
2 years
October 9, 2016
July 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in VAS (Visual Ananlof Scale) for pain assessment
using an validated score 0 (lowest) to 10 (highest)
1 month
Secondary Outcomes (1)
Change in Fugl-Meyer assessment
1 month
Study Arms (3)
Intervention
EXPERIMENTALElectrode 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 COMPARATORThe 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 INTERVENTIONPatients hospitalized in the Loewenstein department of neurologic rehabilitation after first clinical stroke who do not have hemiplegic shoulder pain.
Interventions
Device: neuroConn\_CE\_DC-STIMULATOR. Anodal stimulation to affected hemisphere.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Shoulder pain predating the stroke
- Epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Motti Ratmansky
Loewenstein Rehabilition Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of pain unit, Loewenstein Hospital
Study Record Dates
First Submitted
October 9, 2016
First Posted
October 11, 2016
Study Start
November 1, 2018
Primary Completion
November 1, 2020
Study Completion
November 1, 2020
Last Updated
July 18, 2018
Record last verified: 2018-07