NeuralgiaPhase 2DBSforPainNCT01899170
Towards Individualized Deep Brain Stimulation Treatment of Chronic Neuropathic Pain
A Phase 2 study testing Deep brain stimulation, Cervel Neurotech, Multi-coil TMS and 11C-Carfentanil in people with Neuralgia, run by University of Aarhus at 1 site in Denmark.
Trial summary
Chronic neuropathic pain affects millions of individuals worldwide. It causes marked reduction of health, utility and quality of life and represents a considerable economic burden to society due to loss of work capacity and large treatment expenses. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuralgia
- What is being tested?
- Deep brain stimulation, Cervel Neurotech, Multi-coil TMS and 11C-Carfentanil
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2014to 1 Aug 2019
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General inclusion criteria (case and control):
- No gender criteria
- Age > 25 years.
- Legal competency.
- Ability to comply with the proposed protocol schedule.
- Stability of chronic medical diseases.
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- A negative validated pregnancy test for fertile female participants prior to project enrolment.
- Use of validated anti-conception for fertile female participants
- Case-specific inclusion criteria:
- Well-defined neuropathic pain [21].
- Chronic and stable pain condition. Numerical Rating Scale score > 5.
- Documented resistance to, or poor tolerance of pharmacological treatments. Unless contraindicated, the treatment must have included opiate derivatives, tri-cyclic antidepressants and anti-epileptic drugs.
Who cannot join
- General exclusion criteria:
- Pregnancy or nursing.
- Cognitive impairment.
- Alcohol or drug abuse
- Severe psychiatric disorders.
- Allergies towards compounds used in the trial, such as PET tracers, Capsaicin, etc. Other significant medical allergies.
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- Severe medical disorders
- Neurodegenerative disorders
- Severe cerebrovascular diseases and risk-factors, malignant hypertension, vascular abnormalities.
- Prior intracranial surgery
- Cardiac pacemaker or other implanted electronic medical devices
- Coagulopathy (excl. drug induced)
- Structural brain abnormalities
- Epilepsy or prior isolated seizure.
- Severe obesity
- Severe claustrophobia
- Magnetic metallic implants
- Other conditions that may contraindicate deep brain stimulation surgery, full anesthesia, transcranial magnetic stimulation, PET/CT imaging (specifically the use of carfentanil) or magnetic resonance imaging. This will be evaluated according to specific investigational product specifications and clinical guidelines.
- Control specific exclusion criteria:
- Chronic pain syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Chronic neuropathic pain affects millions of individuals worldwide. It causes marked reduction of health, utility and quality of life and represents a considerable economic burden to society due to loss of work capacity and large treatment expenses. The proposed project will explore new and rational methods for deep brain stimulation treatment of patients with severe chronic neuropathic pain, resistant to conventional treatment. Deep brain stimulation is a neurosurgical procedure in which a small stimulating electrode is implanted into deep brain areas. Furthermore, we will utilize new positron emission tomography neuroimaging and a new prototyped technology, called targeted transcranial magnetic stimulation, to predict the outcome of deep brain stimulation and localize brain regions with maximum symptom relief for each patient. This will optimize the selection of patients for deep brain stimulation and provide a rational customized choice of brain target for each patient, without surgical intervention. Novel techniques will be validated on healthy volunteers and at the same time provide new insights into the mechanisms underlying brain stimulation and pain perception. The project has great clinical impact, potential for innovative development and industrial spin-out, facilitates exchange for Danish research talents and senior researchers with Stanford University and California Pacific Medical Research Institute in San Francisco, and unites world leading experts in pain research and clinical treatment to achieve its goals.
- Conditions
- Neuralgia
- Being tested
- Deep brain stimulation, Cervel Neurotech, Multi-coil TMS, 11C-Carfentanil
- Keywords
- deep brain stimulation, multi-coil transcranial magnetic stimulation, PET-imaging, personalized treatment
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationProcedure or surgery
Implantation of a deep brain stimulation electrode into pain processing brain areas
Cervel Neurotech, Multi-coil TMSDevice
Also called TMS
Non-invasive selective stimulation of deep brain areas using magnetic fields.
11C-CarfentanilDrug
Also called 11C-Carfentanyl
PET-radioligand for functional brain imaging to assess opioid binding. The compound is a potent synthetic opioid.
| Study group | Role | What they receive |
|---|---|---|
| Sham-DBS | Sham comparator | Only patients. Inactive deep brain stimulation for the initial three months following implantation. Receives: Procedure: Deep brain stimulation; Device: Cervel Neurotech, Multi-coil TMS; Drug: 11C-Carfentanil |
| Active DBS | Active comparator | Only patients. Active deep brain stimulation for the initial three months following surgery. Receives: Procedure: Deep brain stimulation; Device: Cervel Neurotech, Multi-coil TMS; Drug: 11C-Carfentanil |
| TMS and PET imaging | Experimental | This experiment includes all participants (cases and controls). Each subject will undergo both active and sham stimulation (cross-over) with Cervel Neurotech Multi-coil TMS and related test/re-test PET imaging with 11C-Carfentanil. Only patients will proceed into deep brain stimulation experiments. Receives: Device: Cervel Neurotech, Multi-coil TMS; Drug: 11C-Carfentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief upon deep brain stimulation of the dorsal anterior cingulate cortex.
We will measure the changes in pain ratings upon deep brain stimulation of the dorsal anterior cingulate gyrus. Results will be based on the numerical rating scale and validated questionnaires. We will compare active and sham stimulation and changes upon activation of initial sham-stimulation.
Measured: Assessment after 3 and 12 months of active stimulation
Predictive values of PET imaging and transcranial magnetic stimulation on deep brain stimulation outcome
Individuals will be classified according to PET activity/no-activity and positive/null-negative outcome of transcranial magnetic stimulation. We will correlate the effect of deep brian stimulation to these categories and evaluate their predictive values.
Measured: Assessed upon final evaluation of deep brain stimulation outcome (expected 2 years)
Secondary outcomes (2)
Effect of deep brain stimulation on cingulate opioid binding and blood flow.
We will do test/re-test PET imaging before and after deep brain stimulation surgery to assess the effect of this treatment on cingulate opioid binding and blood flow. We will utilize 11C-Carfentanil and 15O-water PET, respectively.
Measured: After 3 and 12 months of active deep brain stimulation
Pain relief upon individualized deep brain stimulation
Patients that derive no benefit from initial deep brain stimulation treatment of the dorsal anterior cingulate, will be offered deep brain stimulation of another expectedly efficacious brain area. The choice of target will be based of PET images and magnetic stimulation testing. Results of deep brain stimulation will be based on the numerical rating scale and validated pain questionnaires.
Measured: After 3 and 12 months of active deep brain stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study start1 Apr 2014
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Why it stopped: Device for multi coil TMS no longer supported
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, California Pacific Medical Center Research Institute
- Responsible party
- Sponsor
- Investigators
- Jens Christian H Sørensen, MD,PhD,DMSc, Principal investigator, Aarhus University Hospital, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899170
- Sponsor's protocol ID
- 28052013
- Other IDs
- 2013-002385-39
- Acronym
- DBSforPain
- Status last verified
- Jul 2013
- First submitted
- 3 Jul 2013
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Individualized Deep Brain Stimulation Treatment of Chronic Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01899170
- Acronym / sponsor ID
- DBSforPain / 28052013
- Conditions
- Neuralgia
- Keywords
- deep brain stimulation, multi-coil transcranial magnetic stimulation, PET-imaging, personalized treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device for multi coil TMS no longer supported
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Stanford University, California Pacific Medical Center Research Institute
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 15 Jul 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.
Chronic neuropathic pain affects millions of individuals worldwide. It causes marked reduction of health, utility and quality of life and represents a considerable economic burden to society due to loss of work capacity and large treatment expenses. The proposed project will explore new and rational methods for deep brain stimulation treatment of patients with severe chronic neuropathic pain, resistant to conventional treatment. Deep brain stimulation is a neurosurgical procedure in which a small stimulating electrode is implanted into deep brain areas. Furthermore, we will utilize new positron emission tomography neuroimaging and a new prototyped technology, called targeted transcranial magnetic stimulation, to predict the outcome of deep brain stimulation and localize brain regions with maximum symptom relief for each patient. This will optimize the selection of patients for deep brain stimulation and provide a rational customized choice of brain target for each patient, without surgical intervention. Novel techniques will be validated on healthy volunteers and at the same time provide new insights into the mechanisms underlying brain stimulation and pain perception. The project has great clinical impact, potential for innovative development and industrial spin-out, facilitates exchange for Danish research talents and senior researchers with Stanford University and California Pacific Medical Research Institute in San Francisco, and unites world leading experts in pain research and clinical treatment to achieve its goals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham-DBS | Sham comparator | Procedure: Deep brain stimulation, Device: Cervel Neurotech, Multi-coil TMS, Drug: 11C-CarfentanilOnly patients. Inactive deep brain stimulation for the initial three months following implantation. |
| Active DBS | Active comparator | Procedure: Deep brain stimulation, Device: Cervel Neurotech, Multi-coil TMS, Drug: 11C-CarfentanilOnly patients. Active deep brain stimulation for the initial three months following surgery. |
| TMS and PET imaging | Experimental | Device: Cervel Neurotech, Multi-coil TMS, Drug: 11C-CarfentanilThis experiment includes all participants (cases and controls). Each subject will undergo both active and sham stimulation (cross-over) with Cervel Neurotech Multi-coil TMS and related test/re-test PET imaging with 11C-Carfentanil. Only patients will proceed into deep brain stimulation experiments. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- No gender criteria
- Age > 25 years.
- Legal competency.
- Ability to comply with the proposed protocol schedule.
- Stability of chronic medical diseases.
Key exclusion criteria (20 listed)
- Pregnancy or nursing.
- Cognitive impairment.
- Alcohol or drug abuse
- Severe psychiatric disorders.
- Allergies towards compounds used in the trial, such as PET tracers, Capsaicin, etc. Other significant medical allergies.
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 |
|---|---|---|
| Deep brain stimulationImplantation of a deep brain stimulation electrode into pain processing brain areas | Procedure or surgery | Active DBS, Sham-DBS |
| Cervel Neurotech, Multi-coil TMSAlso: TMSNon-invasive selective stimulation of deep brain areas using magnetic fields. | Device | Active DBS, Sham-DBS, TMS and PET imaging |
| 11C-CarfentanilAlso: 11C-CarfentanylPET-radioligand for functional brain imaging to assess opioid binding. The compound is a potent synthetic opioid. | Drug | Active DBS, Sham-DBS, TMS and PET imaging |
Primary outcome
Pain relief upon deep brain stimulation of the dorsal anterior cingulate cortex.
Time frame: Assessment after 3 and 12 months of active stimulation
We will measure the changes in pain ratings upon deep brain stimulation of the dorsal anterior cingulate gyrus. Results will be based on the numerical rating scale and validated questionnaires. We will compare active and sham stimulation and changes upon activation of initial sham-stimulation.
Predictive values of PET imaging and transcranial magnetic stimulation on deep brain stimulation outcome
Time frame: Assessed upon final evaluation of deep brain stimulation outcome (expected 2 years)
Individuals will be classified according to PET activity/no-activity and positive/null-negative outcome of transcranial magnetic stimulation. We will correlate the effect of deep brian stimulation to these categories and evaluate their predictive values.
2 secondary outcomes
Effect of deep brain stimulation on cingulate opioid binding and blood flow.
Time frame: After 3 and 12 months of active deep brain stimulation
Pain relief upon individualized deep brain stimulation
Time frame: After 3 and 12 months of active deep brain stimulation
Results and safety
The study was stopped early (reason given: Device for multi coil TMS no longer supported). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
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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.
Jens Christian H Sørensen, MD,PhD,DMSc principal investigator
Aarhus University Hospital, Department of Neurosurgery
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 Deep brain stimulation, Cervel Neurotech, Multi-coil TMS and 11C-Carfentanil in people with Neuralgia, run by University of Aarhus at 1 site in Denmark.
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 12 inclusion and 20 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: stopped early, as of the sponsor's last update on 14 Sep 2021. 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 Denmark. 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 was stopped early (reason given: Device for multi coil TMS no longer supported). 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?
Pain relief upon deep brain stimulation of the dorsal anterior cingulate cortex. (time frame: Assessment after 3 and 12 months of active stimulation). The study lists 2 primary outcomes in all. 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 Sep 2021.