Neuropathic PainPhase 2NCT01781065
The Effects of Transcranial Direct Current Stimulation on Central Pain in Patients With Spinal Cord Injury
A Phase 2 study testing transcranial direct current stimulation in people with Neuropathic Pain and Spinal Cord Injury, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the analgesic effect of transcranial direct current stimulation (tDCS) applied on motor cortex in patients with spinal cord injury who have chronic neuropathic pain. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Neuropathic Pain, Spinal Cord Injury
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2008to Jun 2013
- Phase
- Phase 2
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- elapsed time since spinal cord injury more than 6 months
- stable chronic pain for at least 3 preceding months
- pain that was not attributable to cause other that neuropathic pain
- pain that was resistant to various types of medications or physical or complementary medicine treatment
Who cannot join
- any kind of metal implant in the head
- heart disease including having a cardiac maker
- family or personal history of epilepsy, or neuropsychiatric illness
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-802
About this study
Official title: The Analgesic Effect of Transcranial Direct Current Stimulation Over the Primary Motor Cortex on Central Neuropathic Pain Patients With Spinal Cord Injury
The purpose of this study is to evaluate the analgesic effect of transcranial direct current stimulation (tDCS) applied on motor cortex in patients with spinal cord injury who have chronic neuropathic pain.
Read the detailed description
- anodal stimulation of the primary motor cortex (M1)
- anode electrode: C3 (EEG 10/20 system)
- cathode electrode: contralateral supraorbital area
- constant current of 2mA intensity for 20 min
- twice a day with a more than 4 hours interval during of 2 weeks (from Monday to Friday, total 20 treatment session)
- Conditions
- Neuropathic Pain, Spinal Cord Injury
- Being tested
- transcranial direct current stimulation
- Medical subject headings
- Neuralgia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Also called Iomed Phoresor II Auto
| Study group | Role | What they receive |
|---|---|---|
| transcranial direct current stimulation | Experimental | Anodal stimulation on motor cortex Receives: Device: transcranial direct current stimulation |
| Sham transcranial direct current stimulation | Sham comparator | Turn off after 10 s of stimulation Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale for average pain over the preceding 24h
Measured: before the first tDCS session, and 1, 2, 4, 6 and 8 wk after the start of the stimulation
Secondary outcomes (1)
Patient global impression of change for pain
Measured: before the first tDCS session, and 1, 2, 4, 6, and 8 wk after the start of the stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startMar 2008
- Primary completionFeb 2009
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung-Ik Shin, Seoul National University Bundang Hospital
- Investigators
- Hyung Ik Shin, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781065
- Sponsor's protocol ID
- 11-2008-010 SNUBH
- Status last verified
- Jul 2013
- First submitted
- 29 Jan 2013
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.
PubMed 16564618
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effect of Transcranial Direct Current Stimulation Over the Primary Motor Cortex on Central Neuropathic Pain Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01781065
- Acronym / sponsor ID
- 11-2008-010 SNUBH
- Conditions
- Neuropathic Pain, Spinal Cord Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 31 Jan 2013 (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 this study is to evaluate the analgesic effect of transcranial direct current stimulation (tDCS) applied on motor cortex in patients with spinal cord injury who have chronic neuropathic pain.
Detailed description
- anodal stimulation of the primary motor cortex (M1)
- anode electrode: C3 (EEG 10/20 system)
- cathode electrode: contralateral supraorbital area
- constant current of 2mA intensity for 20 min
- twice a day with a more than 4 hours interval during of 2 weeks (from Monday to Friday, total 20 treatment session)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcranial direct current stimulation | Experimental | Device: transcranial direct current stimulationAnodal stimulation on motor cortex |
| Sham transcranial direct current stimulation | Sham comparator | Device: transcranial direct current stimulationTurn off after 10 s of stimulation |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- elapsed time since spinal cord injury more than 6 months
- stable chronic pain for at least 3 preceding months
- pain that was not attributable to cause other that neuropathic pain
- pain that was resistant to various types of medications or physical or complementary medicine treatment
Key exclusion criteria (3 listed)
- any kind of metal implant in the head
- heart disease including having a cardiac maker
- family or personal history of epilepsy, or neuropsychiatric illness
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 |
|---|---|---|
| transcranial direct current stimulationAlso: Iomed Phoresor II Auto | Device | Sham transcranial direct current stimulation, transcranial direct current stimulation |
Primary outcome
Numeric rating scale for average pain over the preceding 24h
Time frame: before the first tDCS session, and 1, 2, 4, 6 and 8 wk after the start of the stimulation
1 secondary outcome
Patient global impression of change for pain
Time frame: before the first tDCS session, and 1, 2, 4, 6, and 8 wk after the start of the stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
- Background: PubMed 16564618Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.
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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.
Hyung Ik Shin principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing transcranial direct current stimulation in people with Neuropathic Pain and Spinal Cord Injury, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 3 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: finished, as of the sponsor's last update on 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale for average pain over the preceding 24h (time frame: before the first tDCS session, and 1, 2, 4, 6 and 8 wk after the start of the stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01781065, which also lists 1 linked publication.
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 15 Jul 2013.