Burst-Deep Brain Stimulation of the Thalamus for Neuropathic Facial Pain and Central Poststroke Pain: a Prospective, Randomized Cross-over Feasibility Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Switzerland
Dep. of Neurosurgery, Bern University Hospital
RECRUITING
Bern
Contact Information
Primary
Andreas Nowacki, MD
andreas.nowacki@insel.ch
+41 31 6320014
Backup
Söll Nicole
nicole.soell@insel.ch
+41316323164
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2027-02
Participants
Target number of participants: 20
Treatments
Experimental: Burst DBS first, Tonic DBS second
10 days of Burst-stimulation followed by 10 days of active tonic stimulation (Burst-DBS -\> tonic-DBS)
Active_comparator: Tonic DBS first, Burst DBS second
10 days of active tonic stimulation followed by 10 days of Burst-stimulation (tonic-DBS -\> Burst-DBS)
Related Therapeutic Areas
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov