Towards Individualized Deep Brain Stimulation Treatment of Chronic Neuropathic Pain

NCT01899170 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-09-14

No results posted yet for this study

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

  • Stanford University

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01899170 on ClinicalTrials.gov