Status:
TERMINATED
Towards Individualized Deep Brain Stimulation Treatment of Chronic Neuropathic Pain
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Stanford University
California Pacific Medical Center Research Institute
Conditions:
Neuralgia
Eligibility:
All Genders
25-70 years
Phase:
PHASE2
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 lo...
Eligibility Criteria
Inclusion
- 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 \[21\].
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01899170
Start Date
April 1 2014
End Date
August 1 2019
Last Update
September 14 2021
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Central Jutland, Denmark, 8000