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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002385-39 | EudraCT Number |
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Device for multi coil TMS no longer supported
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| Name | Class |
|---|---|
| Stanford University | OTHER |
| California Pacific Medical Center Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham-DBS | Sham Comparator | Only patients. Inactive deep brain stimulation for the initial three months following implantation. |
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| Active DBS | Active Comparator | Only patients. Active deep brain stimulation for the initial three months following surgery. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Procedure | Implantation of a deep brain stimulation electrode into pain processing brain areas |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Assessed upon final evaluation of deep brain stimulation outcome (expected 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 3 and 12 months of active deep brain stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of transcranial magnetic stimulation on pain ratings, cingulate opioid binding and blood flow | We will do test/re-test PET imaging with transcranial magnetic stimulation in between. We will evaluate quantitative effects on 1) pain ratings using the numerical rating scale, 2) cingulate opioid binding using 11C-carfentanil PET and 3) cingulate blood flow using 15O-water PET. Results will be compared for sham stimulation and active stimulation in each individual, and also between cases and controls. |
Inclusion Criteria:
General inclusion criteria (case and control):
Case-specific inclusion criteria:
Exclusion Criteria:
General exclusion criteria:
Control specific exclusion criteria:
- Chronic pain syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Jens Christian H Sørensen, MD,PhD,DMSc | Aarhus University Hospital, Department of Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Central Jutland | 8000 | Denmark |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| C017114 | carfentanil |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Cervel Neurotech, Multi-coil TMS | Device | Non-invasive selective stimulation of deep brain areas using magnetic fields. |
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| 11C-Carfentanil | Drug | PET-radioligand for functional brain imaging to assess opioid binding. The compound is a potent synthetic opioid. |
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| 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. | After 3 and 12 months of active deep brain stimulation |
| results will be assessed upon final transcranial magnetic stimulation session (last participant/last treatment, average 5 weeks) |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |