Thalamic-Burst-DBS for Neuropathic Pain
Burst-Deep Brain Stimulation of the Thalamus for Neuropathic Facial Pain and Central Poststroke Pain: a Prospective, Randomized Cross-over Feasibility Trial
Insel Gruppe AG, University Hospital Bern
20 participants
Sep 1, 2022
INTERVENTIONAL
Conditions
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 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
Inclusion Criteria8
- 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 Criteria13
- 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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Interventions
Patients undergo stereotactic implantation of DBS electrodes in the thalamus under local anesthesia. The DBS electrodes will be connected to an external pacemaker for a time period of four weeks. On the first day following surgery, patients will undergo an empirical clinical testing of the stimulation parameter settings. At the same day patients will undergo somatosensory- and contact heat-evoked potential recording for phenotype-stratification (post-hoc analysis).During the next 24 days with the electrodes externalized and connected to the external pacemaker, patients will be randomly assigned in a 1:1 ratio to one of the two groups that undergo two blocks of stimulation: 12 days of of Burst-stimulation followed by 12 days active tonic stimulation (Burst-DBS -\> tonic-DBS) Between each stimulation block the stimulator will be switched off for one day to prevent any hang-over effects of stimulation (wash-out period).
Patients undergo stereotactic implantation of DBS electrodes in the thalamus under local anesthesia. The DBS electrodes will be connected to an external pacemaker for a time period of four weeks. On the first day following surgery, patients will undergo an empirical clinical testing of the stimulation parameter settings. At the same day patients will undergo somatosensory- and contact heat-evoked potential recording for phenotype-stratification (post-hoc analysis).During the next 24 days with the electrodes externalized and connected to the external pacemaker, patients will be randomly assigned in a 1:1 ratio to one of the two groups that undergo two blocks of stimulation: 12 days of active tonic stimulation followed by 12 days of Burst-stimulation (tonic-DBS -\> Burst-DBS) Between each stimulation block the stimulator will be switched off for one day to prevent any hang-over effects of stimulation (wash-out period).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05204472