💬In plain words
What the trial is, and whether it could suit you
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 developed in the field of spinal cord stimulation (SCS) for a variety of neuropathic pain disorders. To date, this stimulation paradigm has not yet been evaluated systematically for deep brain stimulation to treat neuropathic pain disorders.
The purpose of this clinical investigation is to investigate if Burst-DBS of the thalamus is more effective compared to classical continuous low-frequency stimulation DBS to reduce the subjective pain intensity in patients with chronic neuropathic pain after stroke or in patients with neuropathic facial pain.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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:
1. post-herpes-zoster-neuralgia,
2. posttraumatic, neuropathic facial pain,
3. 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 Criteria:
* 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)
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