tDCS and VI to Treat Neuropathic Pain and Function in SCI
tDCS Stimulation Combined With VI as a Possible Therapy for Enhancing Functional Ability in SCI With Neuropathic Pain
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) will be applied for patient who suffer from neuropathic pain following spinal cord injury The tDCS treatment will be coupled with a video of a man walking (creating a visual illusion) in order to enhance functional ability and reduce pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Typical duration for not_applicable
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
January 29, 2017
CompletedFirst Posted
Study publicly available on registry
February 14, 2017
CompletedStudy Start
First participant enrolled
March 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2020
CompletedFebruary 14, 2017
February 1, 2017
3 years
January 29, 2017
February 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in SCIM 3 (scale)
spinal cord independence measure
up to 7 day before and following the treatment
Secondary Outcomes (2)
change in VAS (Visual Analog Scale)
up to 7 day before and following the treatment
change in BPI (Brief Pain Inventory)
up to 24h before and following the treatment
Study Arms (2)
intervention tDCS+VI
EXPERIMENTALThe anode will be placed over C3-C4 (EEG 10/20 system) to target M1 and the cathode over the contralateral supraorbital area. The stimulation will apply to the hemisphere which contralateral to the more painful hemi body. 2mA will be delivered over 20 min via neuroConn DC stimulator combined with video presenting walking legs. A total of 10 sessions (5 per week) will be administrated at the same manner.
tDCS Sham+VI Sham
SHAM COMPARATORThe stimulation will be turned on for only short duration (up to 30 sec), the video film will contains graphical illustrations or nature movie without human movement.
Interventions
2mA will be delivered over 20min to M1 via neuroConn DC stimulator combined with video presenting walking legs.
2mA will be delivered up to 30 sec to M1 via neuroConn DC stimulator combined with video presenting graphical illustration or nature movie for total duration of 20 min.
Eligibility Criteria
You may qualify if:
- patients hospitalized in spinal cord rehabilitation department
- neuropathic pain following spinal cord injury
- able to seat on a wheel chair
- able to understand and comply with basic instructions
- Hebrew speakers
You may not qualify if:
- epilepsy
- pregnancy
- non-neuropathic pain
- medical condition that affect cognitive functioning
- medical condition other then the spinal cord injury that affect functioning
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Motti Ratmansky, MD
Loewenstein Rehabilitation 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
- Director, Pain Unit
Study Record Dates
First Submitted
January 29, 2017
First Posted
February 14, 2017
Study Start
March 15, 2017
Primary Completion
March 15, 2020
Study Completion
March 15, 2020
Last Updated
February 14, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share