Neuropathic PainNCT02465918
Cyclization of Motor Cortex Stimulation
A study testing motor cortex stimulation (Change of Stimulation Timing) in people with Neuropathic Pain, run by University of British Columbia at 1 site in Canada.
Trial summary
Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic pain not responsive to medication. An electrode is placed on the surface of the brain and connected to a programmable battery in the chest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- motor cortex stimulation (Change of Stimulation Timing)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Jul 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient more than 18 years of age
- Chronic neuropathic pain effectively treated with motor cortex stimulation
- Stable medication during the trial
- Willing and able to comply with the study protocol and to return per the follow-up visit schedule and able to provide informed consent.
Who cannot join
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
- Technical malfunction of the MCS device
- History of seizures
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Vancouver General Hospital
Vancouver, British Columbia, V5Z 4E3
About this study
Official title: The Relationship Between Cyclizing Stimulation and Effective Stimulation During Motor Cortex Stimulation
Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic pain not responsive to medication. An electrode is placed on the surface of the brain and connected to a programmable battery in the chest.
The strength of stimulation can be individually adjusted by changing the voltage of stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low voltage will not provide pain control.
The aim of this study is to analyze the optimal stimulation timing parameters in patients already implanted with MCS and have received good pain relief. The investigators wish to cyclize on/off MCS in order to save the battery life of the stimulator and also decrease stimulus habituation. The investigators hope to determine these timing parameters while maintaining optimal pain relief.
- Conditions
- Neuropathic Pain
- Being tested
- motor cortex stimulation (Change of Stimulation Timing)
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor cortex stimulation (Change of Stimulation Timing)Device
| Study group | Role | What they receive |
|---|---|---|
| Original Setting- MCS 30 min off/0 min off | Active comparator | Patients at baseline with their original MCS settings: on 30 minutes, off 0 minutes in any single half-hour. Receives: Device: motor cortex stimulation (Change of Stimulation Timing) |
| MCS 25 min on/5 min off | Experimental | Patient MCS settings programmed to: on 25 minutes, off 5 minutes in any single half-hour. Receives: Device: motor cortex stimulation (Change of Stimulation Timing) |
| MCS 20 min on/10 min off | Experimental | Patient MCS settings programmed to: on 20 minutes, off 10 minutes in any single half-hour. Receives: Device: motor cortex stimulation (Change of Stimulation Timing) |
| MCS 15 min on/15 min off | Experimental | Patient MCS settings programmed to: on 15 minutes, off 15 minutes in any single hour. Receives: Device: motor cortex stimulation (Change of Stimulation Timing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain measured on the Visual Analogue Scale (VAS) with different stimulation settings
Measured: At the End of each trial period, typically 14 days after change in stimulation settings
Secondary outcomes (1)
Quality of Life assessment with the SF-36 questionnaire
Measured: At the end of each trial period, typically at 14 days after change in stimulation settings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 University of British ColumbiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Honey, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465918
- Sponsor's protocol ID
- H15-01420
- Status last verified
- Oct 2020
- First submitted
- 4 Jun 2015
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Treatment of thalamic pain by chronic motor cortex stimulation. Pacing Clin Electrophysiol. 1991 Jan;14(1):131-4. doi: 10.1111/j.1540-8159.1991.tb04058.x.
PubMed 1705329Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Chronic motor cortex stimulation for the treatment of central pain. Acta Neurochir Suppl (Wien). 1991;52:137-9. doi: 10.1007/978-3-7091-9160-6_37.
PubMed 1792954Peyron R, Garcia-Larrea L, Deiber MP, Cinotti L, Convers P, Sindou M, Mauguiere F, Laurent B. Electrical stimulation of precentral cortical area in the treatment of central pain: electrophysiological and PET study. Pain. 1995 Sep;62(3):275-286. doi: 10.1016/0304-3959(94)00211-V.
PubMed 8657427Lima MC, Fregni F. Motor cortex stimulation for chronic pain: systematic review and meta-analysis of the literature. Neurology. 2008 Jun 10;70(24):2329-37. doi: 10.1212/01.wnl.0000314649.38527.93.
PubMed 18541887
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Cyclizing Stimulation and Effective Stimulation During Motor Cortex Stimulation
- ClinicalTrials.gov ID
- NCT02465918
- Acronym / sponsor ID
- H15-01420
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Jun 2015 (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.
Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic pain not responsive to medication. An electrode is placed on the surface of the brain and connected to a programmable battery in the chest.
The strength of stimulation can be individually adjusted by changing the voltage of stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low voltage will not provide pain control.
The aim of this study is to analyze the optimal stimulation timing parameters in patients already implanted with MCS and have received good pain relief. The investigators wish to cyclize on/off MCS in order to save the battery life of the stimulator and also decrease stimulus habituation. The investigators hope to determine these timing parameters while maintaining optimal pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Original Setting- MCS 30 min off/0 min off | Active comparator | Device: motor cortex stimulation (Change of Stimulation Timing)Patients at baseline with their original MCS settings: on 30 minutes, off 0 minutes in any single half-hour. |
| MCS 25 min on/5 min off | Experimental | Device: motor cortex stimulation (Change of Stimulation Timing)Patient MCS settings programmed to: on 25 minutes, off 5 minutes in any single half-hour. |
| MCS 20 min on/10 min off | Experimental | Device: motor cortex stimulation (Change of Stimulation Timing)Patient MCS settings programmed to: on 20 minutes, off 10 minutes in any single half-hour. |
| MCS 15 min on/15 min off | Experimental | Device: motor cortex stimulation (Change of Stimulation Timing)Patient MCS settings programmed to: on 15 minutes, off 15 minutes in any single hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient more than 18 years of age
- Chronic neuropathic pain effectively treated with motor cortex stimulation
- Stable medication during the trial
- Willing and able to comply with the study protocol and to return per the follow-up visit schedule and able to provide informed consent.
Key exclusion criteria (4 listed)
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
- Technical malfunction of the MCS device
- History of seizures
- Unable to provide informed consent
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 |
|---|---|---|
| motor cortex stimulation (Change of Stimulation Timing) | Device | MCS 15 min on/15 min off, MCS 20 min on/10 min off, MCS 25 min on/5 min off, Original Setting- MCS 30 min off/0 min off |
Primary outcome
Change in Pain measured on the Visual Analogue Scale (VAS) with different stimulation settings
Time frame: At the End of each trial period, typically 14 days after change in stimulation settings
1 secondary outcome
Quality of Life assessment with the SF-36 questionnaire
Time frame: At the end of each trial period, typically at 14 days after change in stimulation settings
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 30 Oct 2020.
- Results publication: PubMed 1705329Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Treatment of thalamic pain by chronic motor cortex stimulation. Pacing Clin Electrophysiol. 1991 Jan;14(1):131-4. doi: 10.1111/j.1540-8159.1991.tb04058.x.
- Results publication: PubMed 1792954Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Chronic motor cortex stimulation for the treatment of central pain. Acta Neurochir Suppl (Wien). 1991;52:137-9. doi: 10.1007/978-3-7091-9160-6_37.
- Results publication: PubMed 8657427Peyron R, Garcia-Larrea L, Deiber MP, Cinotti L, Convers P, Sindou M, Mauguiere F, Laurent B. Electrical stimulation of precentral cortical area in the treatment of central pain: electrophysiological and PET study. Pain. 1995 Sep;62(3):275-286. doi: 10.1016/0304-3959(94)00211-V.
- Results publication: PubMed 18541887Lima MC, Fregni F. Motor cortex stimulation for chronic pain: systematic review and meta-analysis of the literature. Neurology. 2008 Jun 10;70(24):2329-37. doi: 10.1212/01.wnl.0000314649.38527.93.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor cortex stimulation (Change of Stimulation Timing) in people with Neuropathic Pain, run by University of British Columbia at 1 site in Canada.
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 4 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 30 Oct 2020. 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 Canada. 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. 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?
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?
Change in Pain measured on the Visual Analogue Scale (VAS) with different stimulation settings (time frame: At the End of each trial period, typically 14 days after change in stimulation settings). 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 NCT02465918, which also lists 4 linked publications.
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 30 Oct 2020.