Thalamic-Burst-DBS for Neuropathic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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.
Eligibility criteria
Qualifiers
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
post-herpes-zoster-neuralgia,
Disqualifiers
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
Trial design
Treatments tested in this trial
- Burst DBS
- Tonic DBS
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov