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Clinical Trials/NCT01899170
NCT01899170
Terminated
Phase 2

Towards Individualized Deep Brain Stimulation Treatment of Chronic Neuropathic Pain

University of Aarhus1 site in 1 country3 target enrollmentApril 1, 2014

Overview

Phase
Phase 2
Intervention
Deep brain stimulation
Conditions
Neuralgia
Sponsor
University of Aarhus
Enrollment
3
Locations
1
Primary Endpoint
Pain relief upon deep brain stimulation of the dorsal anterior cingulate cortex.
Status
Terminated
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2014
End Date
August 1, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.
  • 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 \[21\].

Exclusion Criteria

  • 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.
  • Severe medical disorders
  • Neurodegenerative disorders
  • Severe cerebrovascular diseases and risk-factors, malignant hypertension, vascular abnormalities.
  • Prior intracranial surgery

Arms & Interventions

Sham-DBS

Only patients. Inactive deep brain stimulation for the initial three months following implantation.

Intervention: Deep brain stimulation

Sham-DBS

Only patients. Inactive deep brain stimulation for the initial three months following implantation.

Intervention: Cervel Neurotech, Multi-coil TMS

Sham-DBS

Only patients. Inactive deep brain stimulation for the initial three months following implantation.

Intervention: 11C-Carfentanil

Active DBS

Only patients. Active deep brain stimulation for the initial three months following surgery.

Intervention: Deep brain stimulation

Active DBS

Only patients. Active deep brain stimulation for the initial three months following surgery.

Intervention: Cervel Neurotech, Multi-coil TMS

Active DBS

Only patients. Active deep brain stimulation for the initial three months following surgery.

Intervention: 11C-Carfentanil

TMS and PET imaging

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.

Intervention: Cervel Neurotech, Multi-coil TMS

TMS and PET imaging

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.

Intervention: 11C-Carfentanil

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Effect of deep brain stimulation on cingulate opioid binding and blood flow.(After 3 and 12 months of active deep brain stimulation)
  • Pain relief upon individualized deep brain stimulation(After 3 and 12 months of active deep brain stimulation)

Study Sites (1)

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