Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05204472

Thalamic-Burst-DBS for Neuropathic Pain

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-06

20

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Thalamic-Burst-DBS for Neuropathic Pain

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Age between 18 and 75 years
  • Chronic unilateral neuropathic pain lasting more than 12 months caused by ischemic or hemorrhagic stroke
  • Chronic unilateral neuropathic facial pain lasting more than 12 months caused by post-herpes-zoster neuralgia, posttraumatic neuropathic facial pain, or atypical trigeminal neuralgia after surgery
  • Severe baseline pain intensity (VAS score > 6/10) resistant to neuropathic pain medications including antiepileptics and antidepressants
Not Eligible

You will not qualify if you...

  • Significant cognitive impairment based on MOCA score
  • Psychiatric disorder according to DSMIV axis I or II
  • Psychosocial risk factors such as other chronic pain syndromes, pain catastrophizing, substance abuse, or secondary gain
  • Contraindications to surgery, anesthesia, or MRI
  • Known or suspected inability to comply with or operate the DBS system
  • Woman with childbearing potential
  • Inability to follow study procedures due to language, psychological, or cognitive issues
  • Participation in another interventional trial within 30 days or during this trial
  • Previous enrollment in this trial
  • Investigator's family members, employees, or dependents
  • Planned diathermy, electroshock therapy, or transcranial magnetic stimulation
  • Presence of implanted electrical devices like pacemakers or cardiac defibrillators
  • Poor surgical risk due to multiple severe illnesses or active infections

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dep. of Neurosurgery, Bern University Hospital

Bern, Switzerland, 3000

Actively Recruiting

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Research Team

A

Andreas Nowacki, MD

CONTACT

S

Söll Nicole

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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