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NCT05204472Recruiting

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

Source: ClinicalTrials.gov · Last updated 6 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
12 Jan 2022
Start date
1 Sept 2022
Primary completion date
Aug 2026
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Diseases
Stroke
NCT number
NCT05204472

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 1 Sept 2022 to the primary completion date, Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contra-indication to surgery, anesthesia, or MRI
  • Participation in another interventional clinical trial within 30 days prior to this trial or during the trial
  • Previous enrollment into the current trial
  • Patients who are planned to undergo diathermy, electroshock therapy or transcranial magnetic stimulation (TMS)

Other illness

  • 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
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia. etc. of the subject
  • 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)

Age

  • Significant cognitive impairment (total MOCA score \< 1.5 standard deviations from age- and education adapted mean values),

Other

  • Known or suspected non-compliance or inability to operate the DBS system
  • Woman with childbearing potential
  • Enrolment of the investigator's family members, employees, and other dependent persons

Who the study is looking for

  • 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)

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dep. of Neurosurgery, Bern University Hospital
Coordinator of this site? Confirm its status
BernSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.