SCI - Spinal Cord InjuryNCT03052244
tDCS and VI to Treat Neuropathic Pain and Function in SCI
A study testing tDCS+VI in people with SCI - Spinal Cord Injury, run by Loewenstein Hospital.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- tDCS+VI
- 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
- 15 Mar 2017to 15 Mar 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- epilepsy
- pregnancy
- non-neuropathic pain
- medical condition that affect cognitive functioning
- medical condition other then the spinal cord injury that affect functioning
Trial locations and contacts
No sites are listed yet.
About this study
Official title: tDCS Stimulation Combined With VI as a Possible Therapy for Enhancing Functional Ability in SCI With Neuropathic Pain
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
Read the detailed description
Non-invasive cortical brain stimulation is a promising method for treating cases of neuropathic pain in patients with spinal cord injury (SCI). Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) appears to modulate cortical excitability and can reduce pain levels following SCI, however its effects remaining for short-term and may not be useful for the rehabilitation progress in these patients.
Recent findings suggest that M1 stimulation combined with visual illusion (VI) enhances the reduction in pain which maintain up to 3 month following treatment. The current study aims to reveal whether reduction of neuropathic pain in patients with SCI through tDCS have beneficial effect on functional ability during rehabilitation program.
In the present study the investigators will use anodal stimulation of the M1 via neuroConn DC stimulator. Current intensity of 2mA or sham stimulation will be given during 20 min in parallel to a visual illusion of walking legs (or neutral video for sham stimuli).
- Conditions
- SCI - Spinal Cord Injury
- Being tested
- tDCS+VI, tDCS Sham+VI Sham
- Keywords
- tDCS (trans cranial direct current stimulation), Visual illusion, Neuropathic pain, Spinal cord Injury
- Medical subject headings
- Spinal Cord Injuries, Illusions, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS+VIDevice
Also called transcranial direct current stimulation+visual illusion
2mA will be delivered over 20min to M1 via neuroConn DC stimulator combined with video presenting walking legs.
tDCS Sham+VI ShamDevice
Also called Sham
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention tDCS+VI | Experimental | The 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. Receives: Device: tDCS+VI |
| tDCS Sham+VI Sham | Sham comparator | The 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. Receives: Device: tDCS Sham+VI Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in SCIM 3 (scale)
spinal cord independence measure
Measured: up to 7 day before and following the treatment
Secondary outcomes (2)
change in VAS (Visual Analog Scale)
reported subjective pain scale
Measured: up to 7 day before and following the treatment
change in BPI (Brief Pain Inventory)
Measured: up to 24h before and following the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start15 Mar 2017 (estimated)
- Primary completion15 Mar 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies 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, Loewenstein Hospital
- Investigators
- Motti Ratmansky, MD, Principal investigator, Loewenstein Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052244
- Sponsor's protocol ID
- Loe160029CTIL
- Status last verified
- Feb 2017
- First submitted
- 29 Jan 2017
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS Stimulation Combined With VI as a Possible Therapy for Enhancing Functional Ability in SCI With Neuropathic Pain
- ClinicalTrials.gov ID
- NCT03052244
- Acronym / sponsor ID
- Loe160029CTIL
- Conditions
- SCI - Spinal Cord Injury
- Keywords
- tDCS (trans cranial direct current stimulation), Visual illusion, Neuropathic pain, Spinal cord Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Study start
- 15 Mar 2017 (estimated)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 14 Feb 2017 (actual)
- 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.
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
Detailed description
Non-invasive cortical brain stimulation is a promising method for treating cases of neuropathic pain in patients with spinal cord injury (SCI). Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) appears to modulate cortical excitability and can reduce pain levels following SCI, however its effects remaining for short-term and may not be useful for the rehabilitation progress in these patients.
Recent findings suggest that M1 stimulation combined with visual illusion (VI) enhances the reduction in pain which maintain up to 3 month following treatment. The current study aims to reveal whether reduction of neuropathic pain in patients with SCI through tDCS have beneficial effect on functional ability during rehabilitation program.
In the present study the investigators will use anodal stimulation of the M1 via neuroConn DC stimulator. Current intensity of 2mA or sham stimulation will be given during 20 min in parallel to a visual illusion of walking legs (or neutral video for sham stimuli).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention tDCS+VI | Experimental | Device: tDCS+VIThe 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 comparator | Device: tDCS Sham+VI ShamThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- epilepsy
- pregnancy
- non-neuropathic pain
- medical condition that affect cognitive functioning
- medical condition other then the spinal cord injury that affect functioning
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 |
|---|---|---|
| tDCS+VIAlso: transcranial direct current stimulation+visual illusion2mA will be delivered over 20min to M1 via neuroConn DC stimulator combined with video presenting walking legs. | Device | intervention tDCS+VI |
| tDCS Sham+VI ShamAlso: Sham2mA 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. | Device | tDCS Sham+VI Sham |
Primary outcome
change in SCIM 3 (scale)
Time frame: up to 7 day before and following the treatment
spinal cord independence measure
2 secondary outcomes
change in VAS (Visual Analog Scale)
Time frame: up to 7 day before and following the treatment
change in BPI (Brief Pain Inventory)
Time frame: up to 24h before and following the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Individual participant dataSharing planned: No
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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, MD principal investigator
Loewenstein Rehabilitation Center
Questions about this trial
What is this clinical trial studying?
A study testing tDCS+VI in people with SCI - Spinal Cord Injury, 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 5 inclusion and 5 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 14 Feb 2017. 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 Rotem Gur, Ph.D (97297709170, rotemgu@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 SCIM 3 (scale) (time frame: up to 7 day before and following the treatment). 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 14 Feb 2017.