Neuropathic PainNCT01554332
Motor Cortex Stimulation for Chronic Neuropathic Pain
A study testing Motor Cortex Stimulation using SJM EonC Stimulator in people with Neuropathic Pain and Facial Pain, run by Abbott Medical Devices at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of cortical stimulation (CS) as an adjunctive treatment for chronic neuropathic pain. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Neuropathic Pain, Facial Pain, Post-stroke Pain
- What is being tested?
- Motor Cortex Stimulation using SJM EonC Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2012to 31 Dec 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women (non-pregnant) age 21-70 years;
- Able to give informed consent in accordance with institutional policies;
- Diagnosis of chronic neuropathic pain according to the DN4 Neuropathic Pain Diagnosis scale (score ≥ 4).
- Documented pain for at least 12 months;
- Documented previous or current treatment for neuropathic pain with medications from at least two of the following groups at adequate doses: antidepressants, anticonvulsants, and/or gabapentinoids;
- VAS scores of at least 6 during baselines #1 and 2.
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- Documented clinical diagnosis of neuropathic pain associated with one of the following conditions: facial pain, post-stroke pain, brachial plexus avulsion, or phantom limb pain of the upper extremities.
- In the group with post-stroke pain, only patients with predominant face and upper extremity pain will be included. This will be defined as a difference of ≥ 30% or ≥ 2 points in VAS scores between these regions and lower extremity (in patients who also have pain in the leg).
- No change in current neuropathic pain medication regimen for at least 4 weeks prior to study enrollment.
- Able to comply with all testing and follow-up requirements as defined by the study protocol.
- Must be determined medically stable by surgeon to undergo cortical stimulation surgical procedure.
Who cannot join
- Alcohol, medication, or illegal substance dependence or abuse within last 12 months;
- Trigeminal neuralgia or atypical facial pain.
- Post-stroke pain predominantly in the lower extremity.
- Advanced cardiovascular disease which renders anesthesia and surgery as unsafe as determined by neurosurgeon;
- Clinically relevant abnormality (e.g. tumor) on study MRI;
- Has cardiac pacemaker/defibrillator or other implanted active stimulator;
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- Has a medical condition requiring a repetitive MRI body scan;
- Requires chemotherapy for the treatment of malignancy or requiring chronic oral or intravenous, immunosuppressive, or steroid therapy;
- Is unable to comply with study visit schedule and timeline;
- Past ablative or relevant intracranial surgery;
- A female lactating or of child bearing potential, with a positive pregnancy test or not using adequate contraception;
- Other medical conditions likely to require hospitalization within the next year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Evaluation for the Management of Patients With Chronic Neuropathic Pain With Cortical Stimulation
The purpose of this study is to evaluate the efficacy of cortical stimulation (CS) as an adjunctive treatment for chronic neuropathic pain.
Read the detailed description
Prospective, controlled, double blind, randomized, crossover study with endpoint evaluations at the end of each 3-month treatment period.
An interim analysis will be conducted by a blinded committee when approximately half of the patients have finished the study.
- Conditions
- Neuropathic Pain, Facial Pain, Post-stroke Pain, Brachial Plexus Avulsion, Phantom Limb Pain of the Upper Extremities
- Being tested
- Motor Cortex Stimulation using SJM EonC Stimulator
- Keywords
- Motor Cortex Stimulation, Neuropathic pain
- Medical subject headings
- Neuralgia, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Cortex Stimulation using SJM EonC StimulatorDevice
Patients will be randomized to receive either active stimulation the first 3 months followed by a one-month washout, followed by Sham Stimulation the next 3 months, vs. the reverse order of treatment, followed by single blind stimulation, and an open label phase.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Active comparator | Not described Receives: Device: Motor Cortex Stimulation using SJM EonC Stimulator |
| Sham stimulation | Sham comparator | Not described Receives: Device: Motor Cortex Stimulation using SJM EonC Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The primary analysis of effectiveness is based on the mean differences in changes from the period-specific baseline in VAS scores when patients are receiving 3 month of active vs. 3 months of sham stimulation on a double-blinded fashion.
Measured: Approximately 7 months
Secondary outcomes (10)
Visual Analog Scale, responder
defined as a ≥30% or 2 points reduction from baseline in VAS scores
Measured: Participants will be followed for approximatley 18 months
Neuropathic Pain Symptom Inventory (NPSI)
Measured: Participants will be followed for approximatley 18 months
Brief Pain Inventory (BPI)
Measured: Participants will be followed for approximatley 18 months
Short Form of the McGill Pain Questionnaire(SF-MPQ)
Measured: Participants will be followed for approximatley 18 months
Sickness Impact Profile (SIP)
Measured: Participants will be followed for approximatley 18 months
Medication Quantification Scale (MQS)
Measured: Participants will be followed for approximatley 18 months
SF-36 Health Survey and safety
Measured: Participants will be followed for approximatley 18 months
Pain Catastrophizing Scale (PCS)
Measured: Participants will be followed for approximatley 18 months
Global Impression of Change (patient and evaluator's version)
Measured: Participants will be followed for approximatley 18 months
Device related Adverse Events
Measured: Participants will be followed for approximatley 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startOct 2012
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Karst, Study director, Abbott Neuromodulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554332
- Sponsor's protocol ID
- C-11-13
- Status last verified
- Jun 2020
- First submitted
- 13 Jan 2012
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation for the Management of Patients With Chronic Neuropathic Pain With Cortical Stimulation
- ClinicalTrials.gov ID
- NCT01554332
- Acronym / sponsor ID
- C-11-13
- Conditions
- Neuropathic Pain, Facial Pain, Post-stroke Pain, Brachial Plexus Avulsion, Phantom Limb Pain of the Upper Extremities
- Keywords
- Motor Cortex Stimulation, Neuropathic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Mar 2012 (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 efficacy of cortical stimulation (CS) as an adjunctive treatment for chronic neuropathic pain.
Detailed description
Prospective, controlled, double blind, randomized, crossover study with endpoint evaluations at the end of each 3-month treatment period.
An interim analysis will be conducted by a blinded committee when approximately half of the patients have finished the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Active comparator | Device: Motor Cortex Stimulation using SJM EonC Stimulator |
| Sham stimulation | Sham comparator | Device: Motor Cortex Stimulation using SJM EonC Stimulator |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women (non-pregnant) age 21-70 years;
- Able to give informed consent in accordance with institutional policies;
- Diagnosis of chronic neuropathic pain according to the DN4 Neuropathic Pain Diagnosis scale (score ≥ 4).
- Documented pain for at least 12 months;
- Documented previous or current treatment for neuropathic pain with medications from at least two of the following groups at adequate doses: antidepressants, anticonvulsants, and/or gabapentinoids;
Key exclusion criteria (12 listed)
- Alcohol, medication, or illegal substance dependence or abuse within last 12 months;
- Trigeminal neuralgia or atypical facial pain.
- Post-stroke pain predominantly in the lower extremity.
- Advanced cardiovascular disease which renders anesthesia and surgery as unsafe as determined by neurosurgeon;
- Clinically relevant abnormality (e.g. tumor) on study MRI;
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 using SJM EonC StimulatorPatients will be randomized to receive either active stimulation the first 3 months followed by a one-month washout, followed by Sham Stimulation the next 3 months, vs. the reverse order of treatment, followed by single blind stimulation, and an open label phase. | Device | Active stimulation, Sham stimulation |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Approximately 7 months
The primary analysis of effectiveness is based on the mean differences in changes from the period-specific baseline in VAS scores when patients are receiving 3 month of active vs. 3 months of sham stimulation on a double-blinded fashion.
10 secondary outcomes
Visual Analog Scale, responder
Time frame: Participants will be followed for approximatley 18 months
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Participants will be followed for approximatley 18 months
Brief Pain Inventory (BPI)
Time frame: Participants will be followed for approximatley 18 months
Short Form of the McGill Pain Questionnaire(SF-MPQ)
Time frame: Participants will be followed for approximatley 18 months
Sickness Impact Profile (SIP)
Time frame: Participants will be followed for approximatley 18 months
Medication Quantification Scale (MQS)
Time frame: Participants will be followed for approximatley 18 months
SF-36 Health Survey and safety
Time frame: Participants will be followed for approximatley 18 months
Pain Catastrophizing Scale (PCS)
Time frame: Participants will be followed for approximatley 18 months
Global Impression of Change (patient and evaluator's version)
Time frame: Participants will be followed for approximatley 18 months
Device related Adverse Events
Time frame: Participants will be followed for approximatley 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
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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.
Edward Karst study director
Abbott Neuromodulation
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 using SJM EonC Stimulator in people with Neuropathic Pain and Facial Pain, run by Abbott Medical Devices at 1 site in Brazil.
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 11 inclusion and 12 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 12 Jun 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 Brazil. 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.
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?
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?
Visual Analog Scale (VAS) (time frame: Approximately 7 months). 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 12 Jun 2020.