Status:
RECRUITING
Thalamic-Burst-DBS for Neuropathic Pain
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Central Post-stroke Pain
Neuropathic Pain
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Central post-stroke pain (CPSP) is a neuropathic pain syndrome and one of the major sequelae after ischemic or hemorrhagic cerebral stroke. Recently, a modified stimulation paradigm has been develope...
Detailed Description
Central post-stroke pain (CPSP) is a neuropathic pain syndrome and one of the major sequelae after ischemic or hemorrhagic cerebral stroke. Neuropathic facial pain (NFP) can arise after damage to or a...
Eligibility Criteria
Inclusion
- Signed informed consent
- Age 18-75 years
- Patients suffering from chronic (duration \> 12 months) unilateral neuropathic pain caused by an ischemic or haemorrhagic cerebral stroke or
- Patients suffering from chronic (duration \> 12 months) unilateral neuropathic facial pain due to one of the following causes:
- post-herpes-zoster-neuralgia,
- posttraumatic, neuropathic facial pain,
- atypical trigeminal neuralgia after surgical intervention
- Severe baseline pain intensity (VAS score \> 6/10) considered as resistant to medication specific to neuropathic pain at sufficient doses and durations (including at least antiepileptics and antidepressants)
Exclusion
- Significant cognitive impairment (total MOCA score \< 1.5 standard deviations from age- and education adapted mean values),
- DSMIV axis I or II psychiatric disorder
- Relevant psychosocial risk factors (any of): history of other chronic pain syndrome, pain catastrophizing, substance abuse, secondary gain
- Contra-indication to surgery, anesthesia, or MRI
- Known or suspected non-compliance or inability to operate the DBS system
- Woman with childbearing potential
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia. etc. of the subject
- Participation in another interventional clinical trial within 30 days prior to this trial or during the trial
- Previous enrollment into the current trial
- Enrolment of the investigator's family members, employees, and other dependent persons
- Patients who are planned to undergo diathermy, electroshock therapy or transcranial magnetic stimulation (TMS)
- Patients with implanted electric devices (i.e. cardiac defibrillator, pacemaker)
- Patients who are at poor surgical risk (i.e. patients with multiple severe illnesses or active general infections)
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05204472
Start Date
September 1 2022
End Date
February 1 2027
Last Update
October 17 2024
Active Locations (1)
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1
Dep. of Neurosurgery, Bern University Hospital
Bern, Switzerland, 3000