Towards Individualized Deep Brain Stimulation Treatment of Chronic Neuropathic Pain
NCT01899170 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2021-09-14
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. 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
Interventions
- PROCEDURE
-
Deep brain stimulation
Implantation of a deep brain stimulation electrode into pain processing brain areas
- DEVICE
-
Cervel Neurotech, Multi-coil TMS
Non-invasive selective stimulation of deep brain areas using magnetic fields.
- DRUG
-
11C-Carfentanil
PET-radioligand for functional brain imaging to assess opioid binding. The compound is a potent synthetic opioid.
Sponsors & Collaborators
- collaborator OTHER
-
California Pacific Medical Center Research Institute
collaborator OTHER -
University of Aarhus
lead OTHER
Principal Investigators
-
Jens Christian H Sørensen, MD,PhD,DMSc · Aarhus University Hospital, Department of Neurosurgery
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-04-01
- Primary Completion
- 2019-08-01
- Completion
- 2019-08-01
Countries
- Denmark
Study Locations
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